Abstract
Background
Anxiety disorders are the most common mental health problems. They are chronic and unremitting. Effective treatments are available, but access to services is limited. Media‐delivered behavioural and cognitive behavioural interventions (self‐help) aim to deliver treatment with less input from professionals compared with traditional therapies.
Objectives
To assess the effects of media‐delivered behavioural and cognitive behavioural therapies for anxiety disorders in adults.
Search methods
Published and unpublished studies were considered without restriction by language or date. The Cochrane Depression, Anxiety and Neurosis Review Group's Specialized Register (CCDANCTR) was searched all years to 1 January 2013. The CCDANCTR includes relevant randomised controlled trials from the following bibliographic databases: The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). Complementary searches were carried out on Ovid MEDLINE (1950 to 23 February 2013) and PsycINFO (1987 to February, Week 2, 2013), together with International trial registries (the trials portal of the World Health Organization (ICTRP) and ClinicalTrials.gov). Reference lists from previous meta‐analyses and reports of randomised controlled trials were checked, and authors were contacted for unpublished data.
Selection criteria
Randomised controlled trials of media‐delivered behavioural or cognitive behavioural therapy in adults with anxiety disorders (other than post‐traumatic stress disorder) compared with no intervention (including attention/relaxation controls) or compared with face‐to‐face therapy.
Data collection and analysis
Both review authors independently screened titles and abstracts. Study characteristics and outcomes were extracted in duplicate. Outcomes were combined using random‐effects models, and tests for heterogeneity and for small study bias were conducted. We examined subgroup differences by type of disorder, type of intervention provided, type of media, and recruitment methods used.
Main results
One hundred and one studies with 8403 participants were included; 92 studies were included in the quantitative synthesis. These trials compared several types of media‐delivered interventions (with varying levels of support) with no treatment and with face‐to‐face interventions. Inconsistency and risk of bias reduced our confidence in the overall results. For the primary outcome of symptoms of anxiety, moderate‐quality evidence showed medium effects compared with no intervention (standardised mean difference (SMD) 0.67, 95% confidence interval (CI) 0.55 to 0.80; 72 studies, 4537 participants), and low‐quality evidence of small effects favoured face‐to‐face therapy (SMD ‐0.23, 95% CI ‐0.36 to ‐0.09; 24 studies, 1360 participants). The intervention was associated with greater response than was seen with no treatment (risk ratio (RR) 2.34, 95% CI 1.81 to 3.03; 21 studies, 1547 participants) and was not significantly inferior to face‐to‐face therapy in these studies (RR 0.78, 95 % CI 0.56 to 1.09; 10 studies, 575 participants), but the latter comparison included versions of therapies that were not as comprehensive as those provided in routine clinical practice. Evidence suggested benefit for secondary outcome measures (depression, mental‐health related disability, quality of life and dropout), but this evidence was of low to moderate quality. Evidence regarding harm was lacking.
Authors' conclusions
Self‐help may be useful for people who are not able or are not willing to use other services for people with anxiety disorders; for people who can access it, face‐to‐face cognitive behavioural therapy is probably clinically superior. Economic analyses were beyond the scope of this review.
Important heterogeneity was noted across trials. Recent interventions for specific problems that incorporate clinician support may be more effective than transdiagnostic interventions (i.e. interventions for multiple disorders) provided with no guidance, but these issues are confounded in the available trials.
Although many small trials have been conducted, the generalisability of their findings is limited. Most interventions tested are not available to consumers. Self‐help has been recommended as the first step in the treatment of some anxiety disorders, but the short‐term and long‐term effectiveness of media‐delivered interventions has not been established. Large, pragmatic trials are needed to evaluate and to maximise the benefits of self‐help interventions.
Keywords: Adult; Humans; Anxiety Disorders; Anxiety Disorders/therapy; Cognitive Behavioral Therapy; Cognitive Behavioral Therapy/methods; Depression; Depression/therapy; Desensitization, Psychologic; Desensitization, Psychologic/methods; Health Services Accessibility; Pamphlets; Randomized Controlled Trials as Topic; Relaxation Therapy; Relaxation Therapy/methods; Self Care; Self Care/methods; Therapy, Computer‐Assisted; Therapy, Computer‐Assisted/methods; Treatment Outcome; Videotape Recording
Plain language summary
Self‐help for anxiety disorders
Anxiety disorders are common. They interfere with normal living, and they tend not to go away without treatment. Effective treatments are available, including cognitive behavioural therapy. These are known to work when delivered in person, but many people cannot access face‐to‐face treatment. This review examined 101 clinical trials of self‐help and statistically analysed 92 of them. In these trials, 8403 people received self‐help or were assigned to a control condition.
Overall, self‐help with some support from a professional appears to be more effective than no treatment. Only half of the people who used self‐help were better at the end of treatment, but self‐help may still be considered effective because people with anxiety do not tend to get better without treatment. Self‐help may be less effective than normal face‐to‐face therapy. Some results were difficult to interpret because the effects of treatments varied and the risk of overestimating the results was serious because of limitations in the study methods. We conclude that self‐help is probably better than no treatment, but many people with an anxiety disorder would get better results from treatment provided by a skilled psychologist. Furthermore, most of the self‐help materials used in these studies are intended for research and are not available to the public, so the results reported here may not apply to commercially available products.
Summary of findings
for the main comparison.
| Media‐delivered interventions compared with no intervention for anxiety disorders | ||||||
|
Patient or population: adults with anxiety Settings: recruited from referrals and advertising Intervention: media‐delivered cognitive behavioural therapy or behavioural therapy Comparison: wait‐list, no intervention, treatment as usual | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| No intervention | Media‐delivered intervention | |||||
| Anxiety (any measure), self‐rated at post‐treatment | Across studies, the typical scores in intervention conditions were, on average, 0.67 standard deviations better (with a 95% CI ranging from 0.55 to 0.78 standard deviations) than scores in the control conditions | 4537 (72 studies) |
⊕⊕⊕⊝ moderate 1 | This is a medium effect | ||
| Response (specific), self‐rated at post‐treatment | 180 per 1000 | 421 per 1000 | RR 2.34 (1.81 to 3.03) | 1547 (21 studies) |
⊕⊕⊝⊝ low 1,2 | The probability of clinical improvement doubled, but most people did not improve |
| Depression, self‐rated at post‐treatment | Across studies, the typical scores in intervention conditions were, on average, 0.47 standard deviations better (with a 95% CI ranging from 0.36 to 0.58 standard deviations) than scores in the control conditions | 3682 (50 studies) |
⊕⊕⊕⊝ moderate 1 | This is a medium effect | ||
| Quality of life, self‐rated at post‐treatment | Across studies, the typical scores in intervention conditions were, on average, 0.36 standard deviations better (with a 95% CI ranging from 0.22 to 0.49 standard deviations) than scores in the control conditions | 1344 (18 studies) |
⊕⊕⊝⊝ low 1,2 | This is a medium effect | ||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio. | ||||||
| GRADE Working Group grades of evidence: High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1Downgraded for inconsistency.
2Downgraded for risk of bias.
2.
| Media‐delivered interventions compared with face‐to‐face intervention for anxiety disorders | ||||||
|
Patient or population: adults with anxiety Settings: recruited from referrals and advertising Intervention: media‐delivered cognitive behavioural therapy or behavioural therapy Comparison: face‐to‐face interventions | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Face‐to‐face intervention | Media‐delivered intervention | |||||
| Anxiety (any measure), self‐rated at post‐treatment |
SMD ‐0.23 (‐0.36 to ‐0.09) Across studies, the typical scores in intervention conditions were, on average, 0.23 standard deviations worse (with a 95% CI ranging from 0.09 to 0.36 standard deviations) than scores in the control conditions |
1360 (24) | ⊕⊕⊝⊝ low 2,3 | This is a small effect in favour of face‐to‐face intervention | ||
| Response (specific), self‐rated at post‐treatment | 537 per 1000 | 419 per 1000 | RR 0.78 (0.56 to 1.09) | 575 (10) | ⊕⊝⊝⊝ very low1,2,3 | The difference was not statistically significant |
| Depression, self‐rated at post‐treatment | Across studies, the typical scores in intervention conditions were, on average, 0.01 standard deviations worse (with a 95% CI ranging from ‐0.21 to 0.22 standard deviations) than scores in the control conditions | 906 (13) | ⊕⊝⊝⊝ very low 1,2,3 | The difference was not statistically significant | ||
| Quality of life, self‐rated at post‐treatment | Across studies, the typical scores in intervention conditions were, on average, 0.08 standard deviations better (with a 95% CI ranging from ‐0.23 to 0.38 standard deviations) than scores in the control conditions | 282 (4) | ⊕⊝⊝⊝ very low 1,2,3 | The difference was not statistically significant | ||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio. | ||||||
| GRADE Working Group grades of evidence: High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1Downgraded for inconsistency.
2Downgraded for risk of bias.
3Downgraded for indirectness.
Background
Description of the condition
Anxiety disorders include generalised anxiety disorder (GAD), obsessive compulsive disorder (OCD), panic disorder (with or without agoraphobia), social phobia (social anxiety disorder) and specific phobias (APA 1994). They are characterised by excessive fears and worries that are difficult to control. Avoidance of feared situations or stimuli (including thoughts) is a cardinal behavioural feature of most anxiety disorders.
Anxiety disorders are the most common class of mental disorders. They are seen across cultures (Demyttenaere 2004) and will be experienced by about 18% of adults every year and by about 32% of people during their lifetimes (Kessler 2005a; Kessler 2005b). Half of all anxiety disorders begin by the age of 11 years (Kessler 2005a; Kessler 2005b), and most are chronic and unremitting (Bruce 2005). Anxiety reduces quality of life (Cramer 2005; Rapaport 2005; Saarni 2007) and contributes to disability (Bloom 2011), causing severe occupational impairment and lost productivity (Greenberg 1999, Ormel 1994). Despite their severity and prevalence, few people with anxiety disorders ever obtain professional treatment, and fewer obtain specialty care (Wittchen 2002).
Description of the intervention
Cognitive behavioural therapy (CBT) and behavioural therapy (BT) are well‐established and effective treatments in the short and medium term (Mitte 2005a; Mitte 2005b; Butler 2006). They are the most researched therapies for anxiety, and they are recommended by the National Institute for Health and Care Excellence (NICE) as front‐line treatments for both adults and young people (Kendall 2011; NCCMH 2006; Pilling 2013). Despite its effectiveness, face‐to‐face therapy is expensive and difficult to access.
To increase access to care and to reduce burden on therapists, computer programmes, books and other types of media have been developed to deliver CBT and BT. Self‐help has been defined as "(a) a therapeutic intervention administered through text‐audiotape, videotape or computer text, or through group meetings or individual exercises such as ‘therapeutic writing’, and (b) designed to be conducted predominantly independently of professional contact" (Bower 2001). Guided self‐help usually involves minimal contact that is primarily "of supportive or facilitative nature, and is meant to support the patient in working through the standardised psychological treatment" (Cuijpers 2010); it is commonly prescribed in primary and secondary care (Clark 2009). An overwhelming majority of behavioural and cognitive therapists use self‐help materials, most often in addition to traditional therapy (Keeley 2002).
How the intervention might work
Behavioural therapy has proved effective in the treatment of people with anxiety. Exposure therapy puts participants in direct and prolonged contact with feared situations (Marks 1971). Exposure in vivo (Emmelkamp 1975) aims to evoke fearful responses and to help participants develop coping strategies that will generalise to everyday circumstances (Foa 1986). Some reviews suggest that progressive muscle relaxation (Jacobson 1938) and controlled breathing are efficacious (Conrad 2007). Little evidence of long‐term benefit has been found when relaxation is used alone; muscle relaxation is sometimes used as an attentional control in the evaluation of treatments for anxiety. Applied relaxation teaches users to use relaxation techniques as coping mechanisms during exposure therapy, and it may provide some other benefits (Öst 1987; Öst 1988).
Cognitive behavioural therapy often includes (1) behavioural experiments, which aim to test one’s fears rather than habituate to a stimulus (Bennett‐Levy 2004), and (2) cognitive restructuring, which teaches people to recognise negative thoughts as they occur and to challenge unrealistic thoughts (Wells 1997). Treatment for anxiety may include other specific techniques, including exposure with ritual prevention for OCD (Steketee 1982), attention training for social anxiety (Rapee 2009) and meta‐cognitive training for GAD (Wells 2006). CBT may also include many non‐specific components that are common to effective forms of psychotherapy (e.g. goal setting, psychoeducation).
Why it is important to do this review
Media‐delivered interventions are intended to be inexpensive and easily accessible. Many literature reviews (Bessell 2002; Bower 2001; Glasgow 1978; Kaltenthaler 2002; Newman 2003; Richards 2003b; Riordan 1989; Schrank 1981; Stevens 1982; Mataix‐Cols 2006; Przeworski 2006; Pull 2006; van Boeijen 2005b) and meta‐analyses (Andrews 2010; Bower 2001; Cuijpers 2009; Cuijpers 2010; den Boer 2004; Gould 1993b; Griffiths 2006; Griffiths 2010b; Haug 2012; Hirai 2006; Kaltenthaler 2008; Lewis 2012; Marrs 1995; Menchola 2007; Norton 2007; Reger 2009; Scogin 1990; Spek 2007) have suggested that media‐delivered CBT may be effective in treating psychological problems, including anxiety, alone or in conjunction with other interventions.
Differences in inclusion criteria and methodological inconsistencies contribute to different conclusions across these reviews. An analysis of interventions for GAD found a large overall effect (g = 0.80, 95% CI 0.29 to 1.30) but significant heterogeneity (Mitte 2005a), similar to a recent review (Haug 2012), which reported a large effect across disorders (g = 0.78, 95% CI 0.67 to 0.90). However, another review (Bower 2001) reports a much smaller effect of self‐help manuals (d = 0.41; 95% CI 0.09 to 0.72), similar to an earlier review of bibliotherapy for many conditions (Marrs 1995). Several reviews reference the Cochrane Handbook for Systematic Reviews of Interventions, but one summed items on the risk of bias tool and failed to follow Cochrane methods for assessing each item (Andrews 2010). Despite the title, one recent review was not systematic (Wade 2010). A recent meta‐analysis (Lewis 2012) missed many studies that should have been included and suggested that media‐delivered interventions have large effects. The most recent analysis used single coding and included no assessment of bias (Haug 2012). Research in this area is advancing quickly, with many studies reported each year, and a rigorous and up‐to‐date review is needed to estimate the effects of media‐delivered interventions provided with or without professional support.
Objectives
To assess the effects of media‐delivered behavioural and cognitive behavioural therapies for anxiety disorders in adults.
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials and cluster‐randomised trials with a parallel‐group design, in which intervention and control groups were enrolled concurrently.
Types of participants
Adults (older than 18 years) with an anxiety disorder (as measured through diagnostic interview or questionnaire) other than post‐traumatic stress disorder (PTSD) or acute stress disorder were included.
We included studies of health anxiety because it shares the cardinal features of anxiety disorders, and it is included in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM‐V), as “illness anxiety disorder”.
We excluded PTSD and acute stress disorder, which differ from other anxiety disorders. They may involve physical injury, difficulty separating past from present events and feelings of guilt. Reactions to severe stress are treated separately in the Tenth Revision of the International Classification of Diseases (ICD‐10) and in DSM‐V.
Studies of people experiencing worries or stress as the result of upcoming events (e.g. medical procedures) were excluded unless participants demonstrated symptoms of an underlying anxiety disorder (e.g. phobic avoidance of dental examinations). Other fears were excluded (e.g. "test anxiety", "fear of public speaking") unless participants met criteria for an anxiety disorder (e.g. specific phobia, social anxiety).
Studies including participants with other problems (e.g. depression) were eligible if participants with anxiety (including those with co‐morbid problems) could be separated from other participants (i.e. those whose problems do not include anxiety), or if most of the population had an anxiety disorder. In the absence of diagnostic interviews, studies were included when average scores on validated measures of anxiety were indicative of caseness.
No restrictions by setting were applied.
Types of interventions
Experimential intervention
Interventions must have delivered CBT or BT using printed materials, audio recordings, video recordings, or computers (including Internet), or via some combination of media. It must have been possible to use them as stand‐alone interventions (i.e. without a therapist), but we included studies with researcher or therapist contact and support. Computer programmes that could be used without the aid of a therapist were included whilst virtual reality systems, which use technology to facilitate therapist‐delivered interventions, were excluded. Interventions that encouraged users to enlist the help of a spouse or a friend were included.
We included studies of media‐delivered interventions alone and studies of media‐delivered interventions as adjuncts to treatment as usual or another intervention.
Comparator
We compared media‐delivered interventions with no intervention and with face‐to‐face behavioural or cognitive behavioural interventions. Only intervention arms in which the difference was a media‐delivered intervention were compared. Thus, '10 hours of therapy' versus '10 hours of therapy plus booklet‐delivered CBT' was eligible; '10 hours of therapy' versus '5 hours of therapy plus booklet‐delivered CBT' was not eligible. If data had been available, we also would have compared media‐delivered interventions with medication, psychoeducation and other forms of media‐delivered interventions.
If it had been possible to analyse the effects of media‐delivered interventions with and without adjunct medication, we would have treated these separately; most trials included participants with and without concurrent medication, so it was not possible to separate “standalone” and “adjunct” treatments. Instead, we report the number of participants in each trial who are taking medication.
Types of outcome measures
Clinician‐ and self‐rated measures were analysed separately because service users and clinicians may have different views about a person's improvement, and because these outcomes may be at risk of bias for different reasons.
Primary outcomes
1. Symptoms of anxiety:
a) Continuous symptom measures (e.g. Agoraphobic Cognitions Questionnaire (Chambless 1984), Beck Anxiety Inventory (Beck 1988), Liebowitz Social Anxiety Scale (Liebowitz 1987));
b) Response (e.g. Clinical Global Impression (Zaider 2003));
c) Recovery (e.g. no longer met criteria for diagnosis).
Secondary outcomes
2. Behavioural test (level of hierarchy achieved).
3. Behavioural test (subjective units of distress).
4. Depression.
5. Mental‐health related disability.
6. Quality of life.
7. Dropout.
Timing of outcome assessment
Outcome measures were grouped by length of follow‐up. We analysed outcomes at post‐treatment, at follow‐up less than six months after randomisation and at follow‐up longer than six months after randomisation. For outcomes measured at multiple time points in a single period, we included the longest time point after randomisation.
Search methods for identification of studies
Published and unpublished studies were considered without language restriction, although all searches were conducted in English and all contacts with authors were initiated in English. No date restrictions were applied.
Electronic searches
Searches were conducted using the following databases (Appendix 1).
The Cochrane Depression, Anxiety and Neurosis Review Group's Specialized Register (CCDANCTR‐Studies and CCDANCTR‐References) (all years to 1 January 2013). This search was conducted at the editorial base by the Group's Trials Search Co‐ordinator (TSC).
The Cochrane Central Register of Controlled Trials (CENTRAL) (all years to 2 April 2012) restricted to records submitted from the CCDANCTR‐References Register (SR‐DEPRESSN). Original search was conducted by the author team.
Ovid MEDLINE (all years to 23 February 2013).
Ovid PsycINFO (all years to February, Week 2, 2013).
International trial registries were also searched via the World Health Organization's trials portal (ICTRP) and ClinicalTrials.gov to identify unpublished or ongoing studies (all years to 1 Januray 2013).
Searching other resources
References from previous meta‐analyses and from articles retrieved during the search were examined for additional studies, and authors of included studies were contacted for unpublished data.
Data collection and analysis
Selection of studies
Two review authors independently screened titles and abstracts to determine which were eligible for inclusion. We were not blind to study authors, institutions, journal of publication or results. Disagreements regarding eligibility were resolved by seeking additional information and through discussion.
Data extraction and management
Data regarding methodology and outcomes were extracted independently in Excel by EM‐W and a second rater.
We included the following information from each study:
Year;
Location (country, urban/rural);
Method of recruitment;
Diagnosis (DSM category, method of assessment);
Inclusion criteria;
Risk of bias (see later).
Participants:
Socio‐demographics (e.g. age, sex);
Co‐morbidities.
For each intervention and comparison group of interest:
Type of intervention;
Type of media;
Duration;
Contact with participants.
For each outcome of interest:
Time points (collected and reported);
Loss to follow‐up.
Main comparisons
Media‐delivered intervention versus no treatment.
Media‐delivered intervention versus face‐to‐face intervention.
Media‐delivered intervention versus psychoeducation.
Media‐delivered intervention versus medication.
Assessment of risk of bias in included studies
EM‐W and a second rater (JJ, RC or AH) coded each included study using the Cochrane Collaboration's tool for assessing risk of bias (Higgins 2011). We judged whether each study was at low, high or unclear risk of bias in relation to sequence generation; allocation concealment; blinding of personnel; blinding of outcome assessors; incomplete outcome data; selective outcome reporting; and other sources of bias. Disagreements were resolved through discussion and by seeking further information.
Measures of treatment effect
Studies often report outcomes using multiple definitions and outcome measures. We gave preference to data that involved the least manipulation by authors or inference by review authors, that is, we extracted raw values at endpoint (e.g. means, standard deviations) rather than calculated effect sizes (e.g. Cohen’s d).
Unit of analysis issues
Cluster‐randomised trials
For each cluster‐randomised trial, we would have determined whether or not its data incorporated sufficient controls for clustering (e.g. robust standard errors, hierarchical linear models). If the data did not have proper controls, then we would have attempted to obtain an appropriate estimate of the data’s intra‐cluster correlation coefficient (ICC). If we could not find an estimate in the report of the trial, then we would have requested an estimate from the trial report authors. If the authors could not provide an estimate, then we would have obtained one from a similar study and conducted a sensitivity analysis to determine whether the results were robust when different values were imputed. We would have used the ICC estimate to control the trial’s data for clustering (Higgins 2011).
Cross‐over trials
For cross‐over trials, we extracted and analysed data from the first period only.
Studies with multiple treatment groups
For factorial studies, we included all comparisons. In other studies with multiple eligible intervention groups (e.g. interventions with or without a specific component), all eligible intervention groups were combined to estimate an average treatment effect compared with the control.
Dealing with missing data
Missing data, and methods for imputing such data, may affect the magnitude and direction of effects. For all analyses, we attempted to include all randomly assigned study participants. When analyses were reported for completers and controlled for the effects of missing cases (e.g. using mixed effects), we extracted the latter. If data were missing for some cases, or if reasons for dropout were not reported, we contacted study authors to request missing data and further information about dropouts. We conducted a sensitivity analysis that excluded studies at high risk of bias (see Sensitivity analysis).
Assessment of heterogeneity
Differences among included studies are discussed in terms of their participants, interventions, outcomes and methods. For each meta‐analysis, we also visually inspected forest plots to see whether the confidence intervals of individual studies had poor overlap (a rough indication of statistical heterogeneity); conducted a Chi2 test; and calculated the I2 statistic (Higgins 2011). We considered meta‐analyses to have heterogeneity when the P value for Chi2 was less than 0.10 and I2 was greater than 25%.
Assessment of reporting biases
For each meta‐analysis that included 10 or more studies, we drew a funnel plot and looked for asymmetry to assess the possibility of small study or reporting bias. We also compared effects using random‐effects and fixed‐effect models (see Sensitivity analysis), and we identified unpublished studies through correspondence and trial registration databases.
Data synthesis
In studies of transdiagnostic interventions (i.e. interventions for multiple anxiety disorders) that reported outcomes separately for participants with specific diagnoses (e.g. panic disorder, social anxiety), symptoms of anxiety were extracted for each diagnostic group where possible.
We used Review Manager (RevMan) Version 5.1 (Review Manager 2011) to conduct all meta‐analyses. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for dichotomous outcomes and were combined with the use of Mantel‐Haenszel methods. Standardised mean differences (SMDs) and 95% CIs were calculated for continuous measures and were combined by using inverse variance methods. Random‐effects models were used because studies included different interventions and populations. When studies reported more than one measure of a particular outcome (e.g. symptoms of social anxiety measured using two scales), we averaged the results in Comprehensive Meta‐Analysis Version 2 software (Borenstein 2005) before entering them into RevMan (e.g. Imdad 2010); the specific measures included in each analysis for each study are listed in the Characteristics of included studies. For all analyses, the area to the right of the 'line of no effect' (SMD > 0, RR > 1) indicates a favourable outcome for media‐delivered interventions.
Subgroup analysis and investigation of heterogeneity
For the primary outcome, we conducted the following subgroup analyses to explore possible differences across the disorders and interventions included in this review. Because many factors co‐varied (e.g. several research groups contributed multiple studies in which the intervention and the population were very similar), these were considered hypothesis generating rather than hypothesis testing.
-
Types of controls.
Wait‐list, attention controls, treatment as usual, adjunct to a treatment versus other treatment alone.
Group psychotherapy, individual psychotherapy.
Types of disorders: GAD, health anxiety, mixed populations, OCD, panic disorder, social anxiety, specific phobias.
Types of interventions: CBT, exposure/desensitisation, relaxation.
Types of media: book, computer/Internet, other.
Types of recruitment: advertising only, referral only, other.
In future updates, we plan to investigate the level of therapist contact as a subgroup analysis.
Sensitivity analysis
We conducted the following sensitivity analyses to determine whether findings were robust to methodological decisions made throughout the review process.
We repeated the analyses using fixed‐effect models.
To investigate the influence of bias, we repeated the primary meta‐analysis by excluding studies at high risk of bias as the result of incomplete outcome data, which we considered the most important source of bias in the available data.
Results
Description of studies
Results of the search
The searches retrieved 1456 (CCDANCTR) and 1323 (Medline and PsycINFO) citations (Figure 1). After duplicates were removed electronically, two review authors screened 2801 abstracts.
1.
Study flow diagram.
Included studies
One hundred and one studies reported in 159 papers were included. Eighteen studies included multiple eligible comparisons, which we treated separately, and 21 studies included multiple eligible intervention groups, which we combined for analysis.
Included studies randomly assigned 8403 participants (mean 83, median 60); the largest included 274 participants with anxiety, depression or mixed anxiety and depression (Proudfoot 2004a). Across studies, approximately 4277 participants received media‐delivered intervention, 2850 received no intervention, 916 received face‐to‐face intervention and 383 were assigned to a group not included in this review.
Ten included studies were not included in the quantitative synthesis because they reported no outcome data that could be analysed (Barrera 1977; Botella 2009; Holdsworth 1996; Koszycki 2011; Salaberria 1995; Tyrer 1988) or compared only two eligible interventions (Fraser 2001; Matthews 2011; Titov 2010b; Tortella‐Feliu 2011). Thus, characteristics are described for 101 studies, and 91 are included in a meta‐analysis.
Design
All studies randomly assigned individuals (Characteristics of included studies). One study randomly assigned general practices, then randomly assigned participants within practices (van Boeijen 2005a).
Setting
Studies were reported between 1973 and 2012; more were reported in 2011 than in any previous year. Most were conducted in four countries: UK (26), Australia (21), USA (17) and Sweden (20).
Participants
Studies included participants who were predominantly female (67% mean of means), white (94%) and in their 30s (37 years), who had more than a high school education (13 years). Most had long‐standing disorders (14 years), and many participants were taking an antidepressant or some other psychiatric medication (35%).
Interventions targeted panic (19 panic disorder, 3 panic disorder with agoraphobia, 3 panic attacks), social anxiety (19 unspecified, 2 specific subtype, 2 general subtype), specific phobias (11 spider, 2 snake, 1 flying, 1 heights), GAD (10), OCD (5), health anxiety (2), several diagnoses (11) or unspecified symptoms of anxiety (14). Some studies included participants with symptoms of anxiety or depression (9); these were included because a minority of participants had depression only, and further details are included in the Characteristics of included studies (Fletcher 2005; Grime 2004; Holdsworth 1996; Maunder 2009; Mead 2005; Proudfoot 2004a; Seekles 2011; Tyrer 1988; Zetterqvist 2003). Most studies assessed participants through a clinical interview (61 face‐to‐face interviews, 28 telephone interviews) or relied on a previous diagnosis (2), although some used questionnaires (10).
Participants were recruited through advertising (56), referral (24), mixed advertising and referral (15), college classes (Lewis 1978; Muller 2011; Shoenberger 2008), prison (Maunder 2009) or workplace (Grime 2004); the recruitment strategy was unclear in one study (Tolin 2011). Exclusion rates varied with method of recruitment and ranged from 0% to 99% (mean 48%). Studies reported that participants were excluded for suicidality (66), depression (54), drug or alcohol misuse (53) or physical health problems (33). Studies also explicitly excluded participants who had received psychotherapy previously (20) or were receiving it currently (64). Most studies (66) restricted the amount or type of medication that participants could be taking or asked participants to remain on a stable dose throughout the study.
Interventions
Of the included studies, 81 compared a media‐delivered intervention with no treatment (including wait‐list and attention controls). Additionally, 29 compared a media‐delivered intervention with a face‐to‐face intervention. Four compared a media‐delivered intervention only with another form of media‐delivered intervention; studies including more than one type of media‐delivered intervention and those comparing multiple forms of media‐delivered intervention only were idiosyncratic in design and objectives, thus a systematic synthesis was not possible. No studies that included a medication group reported outcomes that could be synthesised (Koszycki 2011; Tyrer 1988). Some studies provided information about anxiety or relaxation instructions to control for non‐specific intervention factors (Al‐Kubaisy 1992; Carlbring 2003; Furmark 2009b; Gilroy 2000; Greist 2002; Marks 2004; Schneider 2005); we treated these as attention controls rather than as active comparisons because the comparisons were described with the use of terms like “relaxation placebo” (Gilroy 2000) and “self‐relaxation as a placebo” (Marks 2004).
In most studies, interventions were developed by the authors (89). Exposure and behavioural experiments were the most common components (84). Most studies provided a version of cognitive behavioural therapy (70); others tested exposure alone (19), desensitisation alone (2), muscle relaxation (6), applied relaxation (3) or “self‐examination therapy”, which the author described as a type of CBT but which appears similar to problem solving (Bowman 1997). Interventions were designed to take up to 12 weeks to complete (mean 57 days to post‐treatment assessment), but some consisted of a single session (Heading 2001; Matthews 2011), and others did not specify how long the interventions should take to complete, with some lasting up to six months before assessment (Carlbring 2003; Wright 1997a).
Almost as many studies examined the use of books and booklets (39) as studied Internet‐delivered interventions (43). Most Internet‐delivered interventions did not exceed the capabilities of printed materials, that is, they provided static content on a Website or in a PDF. Some studies tested computer‐delivered interventions (11), mixed media (8) or a computerised telephone system (Greist 2002), and some of these were interactive. Interventions in 13 studies (including 10 of the computerised interventions) had to be used in a general practice office, a clinic, or a workplace.
Therapist contact
In most studies, participants had some contact with providers during treatment, and this is an important source of heterogeneity across studies (82). Contact occurred face‐to‐face (35), by e‐mail (22), by e‐mail and phone (11), by e‐mail and short message service (SMS) (1), by Internet forum only (1) or by telephone (12). When providers had contact with participants, this ranged from 10 minutes to about 6 hours. When studies with no contact and studies in which some contact was common to both groups were excluded (Kenardy 2003; Salaberria 1995), about eight (mean of means) contacts during treatment (six median of means) lasted about 103 (standard deviation (SD) 92) minutes (median 81). A few studies included automated reminders (e‐mail or SMS), which we recorded separately.
Excluded studies
We immediately excluded studies that were not randomised controlled trials, treatments for post‐traumatic stress, treatments for stress associated with medical procedures and other interventions that were not relevant to this review. In other studies, participants did not have anxiety disorders (64); these included studies of hoarding, perfectionism, public speaking, specific fears, stress, test anxiety and trichotillomania (currently listed as an impulse control disorder). Additionally, we excluded studies in which participants were younger than 18 years of age (21), interventions were not stand‐alone (27) or no eligible comparison was available (18). In others, the intervention was not BT or CBT, including a book about snakes (2) and interventions that were educational only (2), attentional retraining alone (2) or designed for group leaders (1; Characteristics of excluded studies). We also excluded a relapse prevention study (Wright 1997) that followed another study in this review (Febbraro 1997a). Ninety studies were identified through correspondence and the checking of reference lists and were excluded.
Two studies appeared likely to be eligible but were discontinued early because of poor recruitment; neither reported any results (Hetherton 2004; Jones 2002b).
Ongoing studies
We identified 11 studies that appear to be ongoing (Characteristics of ongoing studies).
Studies awaiting classification
We identified 15 studies that appear to be completed but not yet reported (Characteristics of studies awaiting classification).
Risk of bias in included studies
Because of the nature of the intervention, it was impossible to blind participants, so all studies were at high risk of bias. Other sources of bias are described later (see also Figure 2).
2.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Allocation
Sequence generation
All included studies were described as randomised controlled trials: 57 specified the method of sequence generation and were at low risk of bias, but the method of randomisation was not described in 34. Ten studies had high risk of bias because randomisation appeared to be inadequate or undermined.
Allocation concealment
Allocation concealment was adequate in most studies reporting the method of randomisation, and 54 studies were at low risk of bias; risk of bias was unclear in 31 and high in 16.
Blinding
Providers
In nine studies, participants had no contact with researchers or clinicians, or providers were blind. Providers were not blind in 89 studies, which were at high risk of bias, and provider blinding was unclear in three studies.
Assessors
Most studies either did not report assessor‐rated outcomes or used blind assessors, thus 85 were at low risk of bias. Blinding of assessors was at high risk of bias in 13 studies and unclear in three. Of the studies that used assessor ratings (46), most (30) reported that assessors were blind.
Incomplete outcome data
For response and recovery (dichotomous) data, we assumed that dropouts in both groups did not improve.
For continuous outcomes, 60 studies reported no dropout or analysed outcomes in a manner that mitigated the effect of missing cases and measures. Methods of analysis were at high risk of bias in 38 studies. It was unclear how three studies handled missing data.
Selective reporting
Most of the studies in the review included multiple outcome measures. Only 20 studies appeared to be free of selective outcome reporting, and 40 clearly omitted measured outcomes and were at high risk of bias. Risk of selective outcome reporting was unclear in 41 studies that reported all outcomes mentioned in the text but did not reference a protocol.
Other potential sources of bias
In addition to the sources of bias already discussed, 11 studies were at risk of bias for other reasons, which are described in the Characteristics of included studies.
Effects of interventions
Comparison 1: Media‐delivered interventions versus no intervention
Primary Outcomes
1.1 Symptoms of anxiety
1.1.a Continuous symptom measures
Any measure of anxiety (mean effect of all measures of anxiety in each study)
At post‐treatment, 72 studies, including 4537 participants, reported any self‐rated measure of anxiety (Figure 3). A medium effect was noted (SMD 0.67, 95% CI 0.55 to 0.78), although heterogeneity was substantial (Chi² = 227.97, degrees of freedom (df) = 75, P < 0.00001, I² = 67%). Only 13 studies, including 684 participants, reported controlled follow‐up within six months; a slightly smaller overall effect was reported (SMD 0.49, 95% CI 0.24 to 0.75) with substantial heterogeneity (Chi² = 32.96, df = 14, P = 0.003, I² = 58%). Long‐term follow‐up (> 6 months) was reported in five studies, including 287 participants; the overall effect was not significant (SMD 0.18, 95% CI ‐0.15 to 0.52), though heterogeneity approached significance (Chi² = 6.60, df = 4, P = 0.16, I² = 39%).
3.
1 Self‐help compared with no treatment.
1.3 Anxiety (any measure), self‐rated at post‐treatment (by disorder).
Specific and general symptoms of anxiety
Effects described previously (any measure of anxiety) include the average of all measures of anxiety for each study, which are listed in the Characteristics of included studies. Most studies in the main analysis measured symptoms of a particular disorder (e.g. Leibowitz Social Anxiety Scale), but to ensure that the results were not influenced by the inclusion of broader measures (e.g. Beck Anxiety Inventory), we also analysed specific and general measures separately.
At post‐treatment, 55 studies including 3192 participants reported a self‐rated measure of a specific anxiety disorder. A medium to large effect was noted (SMD 0.68, 95% CI 0.57 to 0.80), though heterogeneity was moderate (Chi² = 128.49, df = 58, P < 0.00001, I² = 55%). Only 10 studies including 439 participants reported controlled follow‐up within six months, and a slightly smaller overall effect was found (SMD 0.61, 95% CI 0.27 to 0.94) with substantial heterogeneity (Chi² = 31.13, df = 11, P = 0.0004, I² = 65%). Long‐term follow‐up was reported in two studies including 194 participants; the overall effect was not significant (SMD 0.20, 95% CI ‐0.22 to 0.62), although heterogeneity approached significance (Chi² = 5.90, df = 4, P = 0.21, I² = 32%). The pattern of results in subgroup analyses was unchanged.
Additionally, 13 studies including 629 participants reported a clinician‐rated measure of a specific anxiety disorder. There was a large effect (SMD 1.04, 95% CI 0.50 to 1.58), though heterogeneity was considerable (Chi² = 124.76, df = 14, P < 0.00001, I² = 89%). Only five studies including 98 participants reported controlled follow‐up within six months, and a larger overall effect was described (SMD 1.12, 95% CI 0.70 to 1.53). No studies reported long‐term follow‐up. At post‐treatment, studies reporting a clinician‐rated measure were consistent with all self‐rated measures (SMD 0.70, 95% CI 0.46 to 0.95); larger effects on clinician‐rated measures may be explained by bias.
At post‐treatment, 48 studies including 3101 participants reported a self‐rated measure of general symptoms. There was a medium effect (SMD 0.58, 95% CI 0.43 to 0.73), though heterogeneity was considerable (Chi² = 176.38, df = 47, P < 0.00001, I² = 73%). Only nine studies including 569 participants reported controlled follow‐up within six months, and a small effect was described (SMD 0.22, 95% CI 0.06 to 0.39) with no important heterogeneity (Chi² = 7.46, df = 8, P = 0.49, I² = 0%). Long‐term follow‐up was reported in two studies including 194 participants; the overall effect was not significant (SMD ‐0.07, 95% CI ‐0.63 to 0.49), but the studies were inconsistent (Chi² = 3.19, df = 1, P = 0.07, I² = 69%).
1.1.b Response
At post‐treatment, 21 studies including 1547 participants reported response to treatment according to study criteria (Figure 4). Overall, intervention participants were twice as likely to respond (RR 2.34, 95% CI 1.81 to 3.03), although heterogeneity was moderate (Chi² = 40.30, df = 20, P = 0.005, I² = 50%). Only two studies including 128 participants reported controlled follow‐up within six months, and the effect was maintained (RR 2.12, 95% CI 1.18 to 3.79) with no heterogeneity (Chi² = 0.35, df = 1, P = 0.55, I² = 0%). No studies reported long‐term follow‐up. Several studies reported exceptional effect sizes, but only 18% of all participants in the comparison groups were classified as responders at the end of treatment; in absolute terms, media‐delivered interventions were associated with a 31% (95% CI 0.22 to 0.40) increase in response (number needed to treat for an additional beneficial outcome (NNTB = 3)).
4.
1 Self‐help compared with no treatment.
1.26 Response at post‐treatment (by disorder).
1.1.c Recovery
Only nine studies with 605 participants reported the number of participants no longer meeting criteria for diagnosis at the end of treatment. Overall, media‐delivered interventions were associated with a fivefold increase in recovery (RR 5.36, 95% CI 1.62 to 17.68), but heterogeneity was considerable (Chi² = 74.23, df = 8, P < 0.00001, I² = 89%). Only one study reported more than 20% recovery in the comparison group, which could be explained by participants seeking treatment outside the study (Baillie 2002); in the other studies, only 6% of participants in the comparison groups recovered, and media‐delivered interventions were associated with a 45% (95% CI 0.26 to 0.65) increase in recovery (NNTB = 2).
Secondary outcomes
1.2 Behavioural test (level achieved)
Some studies of animal or situational phobias also reported behavioural measures. At post‐treatment, seven studies including 250 participants reported the level completed in a behavioural assessment; a large overall effect was described (SMD 1.11, 95% CI 0.36 to 1.87), but heterogeneity was considerable (Chi² = 37.20, df = 6, P < 0.00001, I² = 84%). When one study (Hassan 1992) that reported an implausible effect was excluded (SMD 8.17), a medium to large effect was still described (SMD 0.76, 95% CI 0.32 to 1.21). At follow‐up, one study including 30 participants reported a large difference (SMD 1.23, 95% CI 0.47 to 1.99). No studies reported long‐term follow‐up.
1.3 Behavioural test (symptoms)
At post‐treatment, five studies including 191 participants reported symptom ratings, and the overall effect was not significant (SMD 0.59, 95% CI ‐0.33 to 1.51), but heterogeneity was considerable (Chi² = 30.48, df = 4, P < 0.00001, I² = 87%). At follow‐up, one study including 30 participants reported no significant difference (SMD 0.60, 95% CI ‐0.11 to 1.31). No studies reported long‐term follow‐up.
1.4 Depression
At post‐treatment, 50 studies including 3682 participants reported a self‐rated measure of depression. A medium effect was described (SMD 0.47, 95% CI 0.36 to 0.58), although heterogeneity was substantial (Chi² = 120.40, df = 50, P < 0.00001, I² = 58%). Only seven studies including 526 participants reported controlled follow‐up within six months, and the combined effect was small (SMD 0.28, 95% CI 0.05 to 0.52), but heterogeneity was substantial (Chi² = 9.89, df = 6, P = 0.13, I² = 39%). When the largest study in the review, which targeted both anxiety and depression (Proudfoot 2004a), was excluded, the effect at follow‐up was not significant (SMD 0.20, 95% CI ‐0.04 to 0.43), and the results were not significantly heterogeneous (Chi² = 6.00, df = 5, P = 0.31, I² = 17%). Long‐term follow‐up was reported in two studies including 194 participants; the overall effect was not significant (SMD ‐0.25, 95% CI ‐0.58 to 0.08), and heterogeneity was not significant (Chi² = 1.11, df = 1, P = 0.29, I² = 10%).
1.5 Mental‐health related disability
At post‐treatment, 20 studies including 1629 participants reported a self‐rated measure of disability. A medium effect was found (SMD 0.48, 95% CI 0.33 to 0.63), although heterogeneity was substantial (Chi² = 37.21, df = 19, P = 0.007, I² = 49%). Only seven studies including 513 participants reported controlled follow‐up within six months, and no significant effect was found (SMD 0.21, 95% CI ‐0.15 to 0.57), but heterogeneity was substantial (Chi² = 22.09, df = 6, P = 0.001, I² = 73%). Long‐term follow‐up was reported in three studies including 147 participants; the overall effect was not significant (SMD ‐0.14, 95% CI ‐0.33 to 0.60), and heterogeneity was not significant (Chi² = 3.50, df = 2, P = 0.17, I² = 43%).
1.6 Quality of life
At post‐treatment, 18 studies including 1344 participants reported a self‐rated measure of quality of life. A medium effect was found (SMD 0.36, 95% CI 0.22 to 0.49), although heterogeneity was moderate (Chi² = 24.58, df = 17, P = 0.10, I² = 31%). Only three studies including 211 participants reported controlled follow‐up within six months, and the combined effect was not significant (SMD 0.08, 95% CI ‐0.19 to 0.35) with no heterogeneity (Chi² = 0.95, df = 2, P = 0.62, I² = 0%). One study reported no effect at long‐term follow‐up (SMD ‐0.06, 95% CI ‐0.48 to 0.36).
1.7 Dropout
Of those receiving media‐delivered interventions and no‐intervention, 855 (20%) and 463 (16%) did not complete the study. A small difference favoured no treatment (RR 0.96, 95% CI 0.94 to 0.99), and heterogeneity was moderate (Chi² = 129.33, df = 77, P = 0.0002, I² = 40%).
Comparison 2: Media‐delivered interventions versus face‐to‐face interventions
Primary Outcomes
2.1 Symptoms of anxiety
2.1.a Continuous symptom measures
Any measure of anxiety (mean effect of all measures of anxiety in each study)
At post‐treatment, 24 studies, including 1360 participants, reported any self‐rated measure of anxiety (Figure 5). A small effect favoured face‐to‐face intervention (SMD ‐0.23, 95% CI ‐0.36 to ‐0.09), and moderate heterogeneity approached significance (Chi² = 31.46, df = 23, P = 0.11, I² = 27%). Only 11 studies including 677 participants reported controlled follow‐up within six months, and a slightly smaller effect favoured face‐to‐face intervention (SMD ‐0.14, 95% CI ‐0.30 to ‐0.01) with no heterogeneity (Chi² = 6.50, df = 10, P = 0.77, I² = 0%). Long‐term follow‐up (> 6 months) was reported in eight studies including 423 participants; the overall difference was not significant (SMD ‐0.16, 95% CI ‐0.50 to 0.18), although heterogeneity was substantial (Chi² = 18.09, df = 7, P = 0.01, I² = 61%) and was attributable to one study that reported a large effect favouring face‐to‐face intervention (Ost 1991); in that study, values for participants in the media‐delivered intervention group were consistent with those of other studies, and the face‐to‐face intervention appeared to be very effective.
5.
2 Self‐help compared with face‐to‐face therapy.
2.3 Anxiety (any measure), self‐rated at post‐treatment (by disorder).
Specific and general symptoms of anxiety
At post‐treatment, 23 studies including 1255 participants reported a self‐rated measure of a specific anxiety disorder. A small effect favoured face‐to‐face intervention (SMD ‐0.23, 95% CI ‐0.37 to ‐0.10), and moderate heterogeneity approached significance (Chi² = 30.57, df = 22, P = 0.11, I² = 28%). Only 10 studies including 573 participants reported controlled follow‐up within six months, and the overall difference was not significant (SMD ‐0.15, 95% CI ‐0.31 to ‐0.02) with no heterogeneity (Chi² = 8.61, df = 9, P = 0.47, I² = 0%). Long‐term follow‐up (> 6 months) was reported in eight studies including 423 participants; the overall difference was not significant (SMD ‐0.20, 95% CI ‐0.54 to 0.14), although heterogeneity was substantial (Chi² = 18.08, df = 7, P = 0.01, I² = 61%) and was attributable to one study that reported a large effect favouring face‐to‐face intervention (Ost 1991). The pattern of results in subgroup analyses was unchanged.
Additionally, six studies including 418 participants reported a clinician‐rated measure of a specific anxiety disorder. The difference was not significant (SMD ‐0.13, 95% CI ‐0.33 to 0.06), and no heterogeneity was noted (Chi² = 3.97, df = 5, P = 0.55, I² = 0%). Only three studies including 185 participants reported controlled follow‐up within six months, and the effect was similar to the effect at post‐treatment (SMD ‐0.19, 95% CI ‐0.69 to 0.30). Only one study including 98 participants reported long‐term follow‐up, and the effect was similar to the effect at post‐treatment (SMD ‐0.13, 95% CI ‐0.53 to 0.28).
At post‐treatment, 11 studies including 627 participants reported a self‐rated measure of general symptoms. No significant difference between groups was noted (SMD ‐0.08, 95% CI ‐0.36 to 0.20), although heterogeneity was substantial (Chi² = 30.19, df = 10, P = 0.0008, I² = 67%). Only five studies including 308 participants reported controlled follow‐up within 6 months, and no significant difference (SMD 0.10, 95% CI ‐0.30 to 0.09) and no important heterogeneity were described (Chi² = 1.24, df = 4, P = 0.87, I² = 0%). Long‐term follow‐up was reported in four studies including 241 participants; no significant difference was noted (SMD 0.04, 95% CI ‐0.22 to 0.30), and no heterogeneity was reported (Chi² = 1.34, df = 3, P = 0.72, I² = 0%).
2.1.b Response
At post‐treatment, 10 studies including 575 participants reported response to treatment (Figure 6). Overall effects were not significant (RR 0.78, 95% CI 0.56 to 1.09), but heterogeneity was substantial (Chi² = 32.38, df = 9, P = 0.0002, I² = 72%). The absolute difference also was not significant (RD ‐0.15, 95% CI ‐0.35 to 0.04), but the absolute rate of response was only 47% overall. Only four studies including 224 participants reported controlled follow‐up within six months, and although no significant difference was found (RR 0.99, 95% CI 0.73 to 1.35), heterogeneity was substantial (Chi² = 7.97, df = 3, P = 0.05, I² = 62%). Three studies including 116 participants reported long‐term follow‐up and no significant difference (RR 0.58, 95% CI 0.20 to 1.64), but heterogeneity was considerable (Chi² = 8.68, df = 2, P = 0.01, I² = 77%).
6.
Forest plot of comparison: 2 Media‐delivered intervention compared with face‐to‐face therapy, outcome. 2.21 Response (specific), self‐rated at post‐treatment (by disorder).
2.1.c Recovery
Only six studies including 587 participants reported the number of participants no longer meeting criteria for diagnosis at the end of treatment. No significant difference in recovery was found (RR 1.05, 95% CI 0.88 to 1.24), and no heterogeneity was noted (Chi² = 2.65, df = 5, P = 0.75, I² = 0%). Only three studies including 354 participants reported controlled follow‐up within six months; no significant difference was found (RR 1.04, 95% CI 0.70 to 1.56), but heterogeneity was substantial (Chi² = 4.02, df = 2, P = 0.13, I² = 50%). Only two studies including 147 participants reported long‐term follow‐up; no significant difference was found (RR 0.90, 95% CI 0.64 to 1.25), but the studies were inconsistent (Chi² = 3.60, df = 1, P = 0.06, I² = 72%).
Secondary outcomes
2.2 Behavioural test (level achieved)
Six studies included behavioural tests. At post‐treatment, five studies including 211 participants reported the level completed; a small to medium effect was found (SMD ‐0.44, 95% CI ‐0.76 to ‐0.13), and no important heterogeneity was noted (Chi² = 4.75, df = 4, P = 0.31, I² = 16%). Two studies including 60 participants reported the level competed at follow‐up; no significant difference was noted (SMD ‐0.02, 95% CI ‐0.74 to 0.71), but the studies were inconsistent (Chi² = 2.02, df = 1, P = 0.16, I² = 50%). Two studies including 122 participants reported the level completed at long‐term follow‐up; no significant difference was found (SMD ‐0.1, 95% CI ‐0.97 to 0.76), but the studies were not consistent (Chi² = 3.83, df = 1, P = 0.05, I² = 74%).
2.3 Behavioural test (symptoms)
At post‐treatment, five studies including 209 participants reported self‐rated symptoms, the overall difference was not significant (SMD ‐0.57, 95% CI ‐1.35 to 0.21) and considerable heterogeneity was noted (Chi² = 26.16, df = 4, P < 0.0001, I² = 85%). One study including 30 participants reported symptoms at follow‐up, and no significant difference was noted (SMD ‐0.09, 95% CI ‐0.79 to 0.60). Three studies including 162 participants reported symptoms at long‐term follow‐up, and no significant difference was found (SMD ‐0.46, 95% CI ‐1.19 to 0.27), but heterogeneity was considerable (Chi² = 8.93, df = 2, P = 0.01, I² = 78%).
2.4 Depression
At post‐treatment, 13 studies including 906 participants reported a self‐rated measure of depression. No overall difference was found (SMD ‐0.01, 95% CI ‐0.22 to 0.21), lthough heterogeneity was substantial (Chi² = 28.27, df = 12, P = 0.005, I² = 58%). Only five studies including 403 participants reported controlled follow‐up within six months, and the combined effect was not significant (SMD 0.09, 95% CI ‐0.19 to 0.36), but heterogeneity was moderate (Chi² = 7.11, df = 4, P = 0.13, I² = 44%). Long‐term follow‐up was reported in five studies including 339 participants; the overall effect was not significant (SMD 0.08, 95% CI ‐0.14 to 0.30), and no important heterogeneity was noted (Chi² = 4.08, df = 4, P = 0.40, I² = 2%).
2.5 Mental‐health related disability
At post‐treatment, 10 studies including 670 participants reported a self‐rated measure of disability. No significant difference was found (SMD ‐0.07, 95% CI ‐0.33 to 0.20), although heterogeneity was substantial (Chi² = 25.58, df = 9, P = 0.002, I² = 65%). Only five studies including 337 participants reported controlled follow‐up within six months, and the combined effect was not significant (SMD ‐0.10, 95% CI ‐0.39 to 0.19), but heterogeneity was moderate (Chi² = 6.80, df = 4, P = 0.15, I² = 41%). Long‐term follow‐up was reported in three studies including 242 participants; the overall effect was not significant (SMD ‐0.21, 95% CI ‐0.47 to 0.04), and no heterogeneity was noted (Chi² = 0.11, df = 2, P = 0.95, I² = 0%).
2.6 Quality of life
At post‐treatment, four studies including 282 participants reported a self‐rated measure of disability. No significant difference was found (SMD 0.08, 95% CI ‐0.23 to 0.38), although heterogeneity was moderate (Chi² = 4.82, df = 3, P = 0.19, I² = 38%). Only two studies including 143 participants reported controlled follow‐up within six months, and the combined effect favoured media‐delivered intervention (SMD 0.40, 95% CI ‐0.07 to 0.73) with no heterogeneity noted (Chi² = 0.64, df = 1, P = 0.43, I² = 0%). One study reported no difference at long‐term follow‐up (SMD ‐0.15, 95% CI ‐0.41 to 0.70).
2.7 Dropout
Of those receiving media‐delivered interventions and face‐to‐face interventions, 855 (20%) and 166 (18%) did not complete the studies. This difference was not significant (RR 1.08, 95% CI 0.90 to 1.30), and no heterogeneity was noted (Chi² = 25.77, df = 26, P = 0.48, I² = 0%).
Comparison 3: Media‐delivered interventions versus psychoeducation
No outcomes could be analysed.
Comparison 4: Media‐delivered interventions versus medication
No outcomes could be analysed.
Subgroup analyses
Comparison 1: Media‐delivered interventions versus no intervention
We examined the impact of methodological differences.
Types of controls
The specific control condition appeared related to relative effects (Chi² = 21.84, df = 3, P = 0.0001, I² = 86%). Specifically, interventions had similar effects compared with wait‐list and attention controls (Chi² = 3.99, df = 2, P = 0.14, I² = 50%), but the overall effect was small when participants were recruited from clinical settings and interventions were compared with treatment as usual (SMD 0.21, 95% CI 0.02 to 0.40). Without studies of treatment as usual, the overall effect was not importantly different from the primary result (SMD 0.72, 95% CI 0.61 to 0.84), and heterogeneity remained substantial (Chi² = 183.67, df = 68, P < 0.00001, I² = 63%).
Types of disorders
Effects were significantly different across types of disorders (Chi² = 17.04, df = 6, P = 0.009, I² = 65%). Studies of mixed disorders reported the smallest combined effect (SMD 0.36, 95% CI 0.19 to 0.52). After these were excluded, subgroups were no longer heterogeneous (Chi² = 3.96, df = 5, P = 0.56, I² = 0%); the overall effect remained medium to large (SMD 0.77, 95% CI 0.64 to 0.91), and heterogeneity remained substantial (Chi² = 157.63, df = 57, P < 0.00001, I² = 64%).
Types of interventions
Effects were not significantly different across types of interventions (Chi² = 1.88, df = 3, P = 0.60, I² = 0%), although the effect for relaxation was not significant. A medium effect for media‐delivered CBT was found (SMD 0.62, 95% CI 0.51 to 0.73), along with substantial heterogeneity (Chi² = 127.24, df = 55, P < 0.00001, I² = 57%).
Types of media
Effects were significantly different across types of media (Chi² = 7.70, df = 3, P = 0.05, I² = 61%) and were largest for Internet‐delivered interventions (SMD 0.79, 95% CI 0.62 to 0.96), although heterogeneity within this group was substantial (Chi² = 132.37, df = 35, P < 0.00001, I² = 74%).
Types of recruitment
Studies that advertised through mass media (including the Internet) reported larger effects than studies recruiting only through clinical referrals (Chi² = 14.98, df = 2, P = 0.0006, I² = 87%), although heterogeneity remained substantial among studies that used advertising (Chi² = 168.47, df = 54, P < 0.00001, I² = 68%).
Comparison 2: Media‐delivered interventions versus face‐to‐face interventions
Types of disorders
Effects were not significantly different across types of disorders (Chi² = 6.22, df = 4, P = 0.18, I² = 35.7%), although studies of specific phobias reported the largest difference between media‐delivered and face‐to‐face interventions (SMD ‐0.39, 95% CI ‐0.73 to ‐0.06), and studies of social anxiety reported the smallest (SMD 0.02, 95% CI ‐0.18 to 0.22).
Types of interventions
Disorders varied with types of therapy, and the difference between media‐delivered exposure and face‐to‐face exposure might be larger than the difference between different deliveries of CBT (Chi² = 2.36, df = 1, P = 0.12, I² = 57.6%), but no between‐group heterogeneity was noted after one study was removed from the exposure group (Ost 1991). Effects did not vary between individual and group CBT.
Types of media
Effects were not significantly different across types of media (Chi² = 5.07, df = 3, P = 0.17, I² = 40.9%).
Types of recruitment
Consistent with the first comparison, studies recruiting through advertisements found smaller differences than studies recruiting only through clinical referrals (Chi² = 2.94, df = 1, P = 0.09, I² = 66.0%), that is, recruiting participants through advertising was associated with more favourable outcomes for media‐delivered therapy.
Discussion
Summary of main results
This review suggests that media‐delivered interventions may be superior to no intervention for people with anxiety; there were positive effects on symptoms of anxiety and depression, response and recovery from illness, disability, and quality of life. Face‐to‐face interventions may be superior to media‐delivered interventions; there were differences favouring face‐to‐face treatment for symptoms of anxiety, but no significant differences in response and recovery from illness, disability and quality of life. Statistical heterogeneity suggests that effects probably vary across participants and interventions. Effects may be maintained after cessation of treatment, but few studies included follow‐up after six months.
Overall, interventions for specific disorders may be superior to interventions for any anxiety disorder. However, one recent transdiagnostic study reported effects that were consistent with the effects of interventions for specific disorders (Titov 2010a). The largest effects were reported in studies of Internet‐based CBT, which may be a superior medium for delivering interventions; however, many of these studies offered only documents for download and printing (PDFs) or access to non‐interactive Websites. More recent trials follow current models for treatment, so changes in intervention components and content may correlate with changes in disorders studied and technologies used, thus confounding these effects.
Overall completeness and applicability of evidence
In general, studies were conducted in high‐income, English‐speaking countries among white, female, middle‐aged participants; these results may not generalise to other settings or participants. Trials had high exclusion rates, for example, one study excluded 100 of 333 applications for high scores on a measure of depression, or for risk of suicide (Titov 2008a). Despite the large numbers of studies and participants in this review, the combined results of efficacy studies cannot demonstrate effectiveness in the general population, and few controlled comparisons suggest that benefits may be maintained after cessation of treatment.
For people seeking treatment, the magnitude of these effects should be interpreted with caution. For example, standardised effects appear similar to effective pharmacotherapies (Kapczinski 2003; Schneier 2001), but there was virtually no response among wait‐list and no‐treatment controls. It is also true that wait‐list participants who receive many face‐to‐face psychotherapies do not respond, but within‐group changes in these studies were not comparable with evidence‐based face‐to‐face interventions in which most participants respond or recover (e.g. Clark 2006).
Differences between media‐delivered interventions and face‐to‐face interventions were small, but some studies (particularly the older ones) provided face‐to‐face interventions designed to control for specific effects of media‐delivered interventions rather than face‐to‐face interventions as they would be provided in usual services. Established interventions may be more effective than these diminished controls. For example, one study demonstrated that a single session of therapist‐guided exposure was greatly superior to media‐delivered intervention for people with specific phobias (Ost 1991).
On the other hand, these interventions increase the number of people receiving help. Anxiety disorders are very common, most people with anxiety never receive treatment and these disorders are naturally chronic and unremitting. For people who would not receive another intervention, NNTBs of 2 and 3 may be valid estimates of treatment efficacy.
Among trials that included some contact with participants, the amount of therapist input varied greatly. Interventions in these studies may not be representative of the interventions that users can access outside of clinical trials or outside of particular services that are designed to offer guided self‐help.
Quality of the evidence
This review includes large numbers of studies and participants. Most trials reported the primary outcome, self‐rated symptoms of anxiety, and the evidence was of moderate quality compared with no treatment (Table 1) but of low quality compared with face‐to‐face intervention (Table 2).
Overall, methods of randomisation and allocation concealment appear unlikely to influence overall effects. However, participants and providers were not blind, and assessors were blind in only 64% of studies using clinician ratings. Compared with self‐ratings, clinician ratings suggest a greater effect compared with no treatment and a smaller difference compared with face‐to‐face therapy. Studies reporting self‐ratings and clinician ratings have reported effects on self‐ratings that were consistent with the average effect for all studies. Additionally, the post‐treatment effect for recovery (SMD 0.75, 95% CI 0.61 to 0.90) was slightly larger than the effect for symptoms of anxiety. Few studies referenced a protocol and reported all outcomes, thus the results of this review may be overestimated because of selective outcome reporting, which could explain the relatively larger effects on clinician‐rated outcomes and recovery. Compared with no intervention and compared with face‐to‐face intervention, 10 of 82 studies and 5 of 29 studies did not report a measure of anxiety that could be included in the main analysis. Incomplete outcome data may also lead to overestimation of continuous outcomes; however, for dichotomous outcomes, we assumed that dropouts did not respond, thus the response and recovery outcomes are unlikely to be overestimated due to missing data. Anxiety disorders tend to be chronic and naturally unremitting, so the assumption that dropouts did not improve may represent the true outcome for most missing cases. Subgroup analyses should be interpreted with caution, as some variables may correlate with risk of bias, for example, average effects of exposure alone may be overestimated compared with the effects of CBT.
Safety data were inadequately reported. Whilst a few studies mentioned adverse events in intervention or control groups, a systematic synthesis was not possible. It is unclear whether adverse events were not reported because they do not occur, or if they were not reported because they were not monitored; most trials excluded participants at greatest risk. Similarly, measures of participant satisfaction, the need for alternative interventions and costs were reported so selectively and incompletely that a formal synthesis would be inappropriate.
Statistical heterogeneity was substantial in most analyses (i.e. I2 > 50%). We attempted to explain this heterogeneity through prespecified analyses, but inconsistency remained within subgroups. Many of the individual studies were not significantly different from zero, but most reported positive effects compared with no intervention.
The quality of most outcomes was low according to GRADE criteria (GRADE 2004), although the quality of response and recovery data was moderate. Outcomes were downgraded for risk of selective outcome reporting. Continuous data were downgraded due to risk of bias, especially for incomplete outcome data.
Potential biases in the review process
This review included a comprehensive search for published and unpublished data. We obtained some unpublished data for 25 studies: Seven completely unpublished studies were included, we obtained an additional report of seven published papers (e.g. a thesis) and authors provided unpublished outcomes for nine studies reported only in published papers. To examine the effects of small study bias, the main analysis was repeated for each comparison using a fixed‐effect model. The magnitude and the precision of the effects were essentially unchanged compared with no treatment (SMD 0.64, 95% CI 0.58 to 0.70) and compared with face‐to‐face therapy (SMD, ‐0.21, 95% CI ‐0.32 to ‐0.10). Funnel plots appeared symmetrical; however, these tests for small study bias were unlikely to identify bias in a review with a large number of small studies, each of which received similar weight in the analysis. The Characteristics of studies awaiting classification include several trials that may be complete, and the Characteristics of excluded studies include two trials that were discontinued.
Several trials included participants with anxiety or depression. Two did not report symptoms of anxiety (Holdsworth 1996; Tyrer 1988), and one excluded participants with depression from the analysis because so few people with depression were recruited (Maunder 2009). Six others contributed to the primary analysis (Fletcher 2005; Grime 2004; Mead 2005; Proudfoot 2004a; Seekles 2011; Zetterqvist 2003). Excluding these studies did not importantly change the overall effect (SMD 0.70, 95% CI 0.58 to 0.82; Chi² = 210.97, df = 69, P < 0.00001, I² = 67%); furthermore, these studies were not included in an analysis restricted to symptoms of a specific anxiety disorder, which was also consistent with the primary analysis.
Agreements and disagreements with other studies or reviews
Many recent reviews have focused on Internet‐ and computer‐delivered interventions, and this review has a wider scope. After accounting for differences in inclusion criteria, this review still includes more trials than previous syntheses of self‐help for anxiety. As a result, few trials appear in both this review and most other meta‐analyses, but overlap is difficult to characterise for other reasons. For example, one review aimed to include studies with less than an hour of contact (Lewis 2012); by contacting the authors, we discovered that many included studies did not meet this criterion. In addition to studies of PTSD, one review (Haug 2012) included a study that was not randomised (the wait‐list taken from another trial in Tillfors 2008), one study that the author described as quasi‐randomised (Lucock 2008) and one study that combined self‐help with another intervention (i.e. Andersson 2006 compared self‐help with in vivo exposure vs waiting list). One meta‐analysis refers to studies that report outcome data but do not appear in the quantitative summary (Spek 2007). Another meta‐analysis omitted many studies that we included, and it included studies that met neither our inclusion criteria nor its stated criteria (Hirai 2006).
Effects on symptoms of anxiety were somewhat smaller than those reported in recent reviews (Andrews 2010; Cuijpers 2010; Griffiths 2010b; Haug 2012; Lewis 2012; Reger 2009), and we report effects for secondary outcomes that have not been widely analysed. Furthermore, this review includes more information about the characteristics of included studies than was provided in previous reviews. This review also includes a comprehensive assessment of risk of bias, which identifies some important limitations in the results that have not been fully considered elsewhere.
Authors' conclusions
Implications for practice.
We found evidence of efficacy compared with no intervention, and media‐delivered interventions could be useful for people who are not seeking other services, but only a small number of people respond and recover when using media‐delivered interventions alone. For people seeking services, face‐to‐face interventions appear to be superior to media‐delivered interventions, leading to higher rates of recovery in practice.
This review identifies a lack of evidence about safety. No reports suggest that media‐delivered interventions are unsafe, although trials have been limited to people who do not have severe depression, substance misuse or other risk factors. Confidence in the results of this review are also mitigated by risk of bias and differences among the included studies.
Many of the included studies provided therapist input averaging just over an hour. Contact during the intervention for research and treatment purposes could be related to compliance and efficacy.
Studies used a variety of delivery formats, and users may prefer different media. Although effects for Internet‐delivered interventions were larger than effects for other media, books with similar content could be equally effective.
This evidence is consistent with recent guidance indicating that people seeking treatment for social anxiety disorder in England and Wales should be offered individual cognitive therapy first; those who decline individual therapy should be offered supported self‐help (Pilling 2013). Current recommendations for the treatment of generalised anxiety disorder suggest a stepped‐care approach (Kendall 2011), which is not consistent with clinical results in this review, but health economic modelling based on these clinical results might inform an update of these guidelines.
Implications for research.
Many studies have demonstrated the efficacy of particular interventions in particular populations; however, some of these interventions are not available outside a few academic groups. Most studies were conducted by the intervention developers. Further research is needed to examine publicly available interventions (e.g. self‐help books) and interventions that could be widely rolled‐out. Some of the included studies have also been examined in uncontrolled longitudinal studies (Hilvert‐Bruce 2012; Mewton 2012; Sunderland 2012), but large effectiveness trials are needed to demonstrate that such interventions work for large populations.
The benefits that can be achieved using media‐delivered interventions may be limited; however, improved treatment manuals, increased interactivity and other innovations might lead to better outcomes than those observed here.
In many trials, study dropout rate was high, and some participants completing assessments did not complete treatment. Large studies could investigate mediators and moderators of compliance by monitoring how participants use Websites and which core components they receive, for example, a case series preceding an ongoing trial includes details about the interventions offered and actual uptake by participants (Stott 2013). Many trials in this review share limitations that have been documented in reports of complex interventions (Grant 2013), and future research would be more useful if similar data about implementation and uptake of interventions were reported consistently across trials (Mayo‐Wilson 2007).
Most people do not respond to media‐delivered interventions, but it is unclear why response and recovery rates are so low. Identifying the differences between responders and non‐responders could help improve treatment effectiveness and could help clinicians determine how to allocate people with anxiety to different services in a stepped‐care framework.
Few studies have compared media‐delivered CBT with CBT as it is normally delivered. Future studies of face‐to‐face therapies might use media‐delivered CBT as a control condition (rather than no treatment). In addition, future studies might examine media‐delivered interventions to prime people before they begin face‐to‐face therapy, to support face‐to‐face therapy or to help maintain gains from face‐to‐face therapy to examine the effects of media‐delivered interventions at various stages in a stepped‐care pathway.
Finally, this review includes a large number of studies and multiple co‐variates, in addition to the main outcomes. Although the subgroup analyses already described are informative, a multivariate meta‐regression might be a useful way to explore the importance of potential mediators and moderators, including contact with professionals.
Acknowledgements
Many authors of included and excluded studies answered questions and provided information about methods, study characteristics and outcomes; we are very grateful for their help in conducting this review.
We gratefully acknowledge support from the Centre for Evidence‐Based Intervention (Department of Social Policy and Intervention; University of Oxford). EM‐W also thanks the Centre for Outcomes Research and Effectiveness (Research Department of Clinical, Educational & Health Psychology; University College London) and the National Collaborating Centre for Mental Health (NCCMH). We thank Rachel Churchill, the Cochrane Methods Groups and anonymous reviewers for their helpful suggestions.
CRG Funding Acknowledgement: The National Institute for Health Research (NIHR) is the largest single funder of the Cochrane Depression, Anxiety and Neurosis Group.
Disclaimer: The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, the NHS or the Department of Health.
Appendices
Appendix 1. Search strategies
1. The Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR) The Cochrane Depression, Anxiety and Neurosis Group (CCDAN) maintains two clinical trials registers at its editorial base in Bristol, UK: a references register and a studies‐based register. The CCDANCTR References Register contains more than 31,900 reports of randomised controlled trials in depression, anxiety and neurosis. Approximately 65% of these references have been tagged to individual, coded trials. The coded trials are held in the CCDANCTR Studies Register, and records are linked between the two registers through the use of unique Study ID tags. Coding of trials is based on the EU‐Psi coding manual. Please contact the CCDAN Trials Search Co‐ordinator for further details.
Reports of trials for inclusion in the Group's registers are collated from routine (weekly), generic searches of MEDLINE (1950‐), EMBASE (1974‐) and PsycINFO (1967‐) and from quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL) and review‐specific searches of additional databases. Reports of trials are also sourced from international trials registers c/o the World Health Organisation’s trials portal (ICTRP), ClinicalTrials.gov, drug companies and handsearching of key journals, conference proceedings and other (non‐Cochrane) systematic reviews and meta‐analyses.
Details of CCDAN's generic search strategies can be found on the Group's Website.
Both Registers (CCDANCTR Studies and CCDANCTR References) were searched by CCDAN's Trials Serach Co‐ordinator (TSC) (all years to 1 January 2013) using the following free‐text terms:
CONDITION = (anxiety or compulsi* or fear* or GAD or hypochondria* or obsess* or OCD or panic or *phobi* or "public speaking" or shy or shyness or "social avoidance") + INTERVENTION = (*psychotherap* or *cognitive* or *behavio* or bibliotherap* or *CBT* or acceptance* or assertive* or attribution or reattribution or re‐attribution or (brief* and *therap*) or commitment* or desensiti* or expos* or *feedback* or "group therapy" or guided or imag* or implosive or “problem solving” or problem‐solving or "solution focused" or solution‐focused or schema or “contingency management” or “functional analys*” or mindfulness* or “mind training” or psychoeducat* or “rational emotive” or rational‐emotive or REBT or relax* or “role play*” or (self* and (*administer* or *direct* or *examin* or *help))) + MODE OF DELIVERY = (audio* or bibliotherap* or book* or "chat room*" or computer* or CD‐ROM or distance* or DVD or homework or information or instruct* or "instant messaging" or iCBT or Internet* or web* or WWW or phone or mobile or e‐mail* or email* or leaflet* or material* or manual or manuals or multi‐media or multimedia or online* or on‐line or pamphlet or pamphlets or program or programme or remote or tele* or tape or taped or video* or virtual* or workbook*)
An additional search of the CCDANCTR‐Studies Register was conducted using a set of controlled vocabulary terms for Condition + Intervention (only) to ensure no studies had been missed: CONDITION = (anxiety or compulsi* or fear* or GAD or hypochondria* or obsess* or OCD or panic or *phobi* or “psychological stress” or "public speaking" or shy or shyness or "social avoidance") + INTERVENTION = (*self* or internet or computer or format or setting) The searches of the Studies Register were limited to adult studies.
2. The Cochrane Central Register of Controlled Trials (CENTRAL)－restricted to records submitted from the CCDANCTR References Register (SR‐DEPRESSN) Authors carried out their own, independent search of the CCDANCTR c/o CENTRAL (all years to 2 April 2012) using the following free‐text terms: #1. anxiety or anxious or agoraphobi* or phobi* or “panic disorder” or asthenia or obsess* or compuls* #2. (audiotherapy or bibliotherapy or book* or CD* or computer* or cyber* or DVD or internet* or “interactive voice response” or interapy or inter‐therapy or intertherapy or multimedia or multi‐media or online or on‐line or pamphlet or pamphlets or pc* or pcs or self administered or self desensiti* or self directed or self exposure or self help or tape or taped or video* or web* or www) or (“beating the blues" or “blues begone” or btstep* or bt step* or caccbt or CALM or CAVE or ccbt or “coping with panic” or fearfighter or “fear fighter” or ffeducation or “ff education” or “glasgow steps” or internetff or internet ff or “living with fear” or “living life to the full” or “managing anxiety” or moodgym or “mood gym” or netcope or net cope or nettff or nett ff or ocfighter or oc fighter or “overcoming anxiety” or “overcoming obsessive” or “overcoming panic” or “overcoming shyness” or “panic control” or “panic online” or “panic surfing” or positivestep or “positive step” or standaloneff or standalone ff or “stop obsessing” or stresspac or “talk to me”):ti,ab,kw #3. SR‐DEPRESSN
3. Ovid MEDLINE and PsycINFO (cross‐search) Additional searches were conducted on Ovid MEDLINE (23 February 2013) and PsycINFO (February, Week 2, 2013) simultaneously, using the following terms:
1. exp Agoraphobia/ 2. exp Hypochondriasis/ 3. exp Obsessive‐compulsive disorder/ 4. exp Panic disorder/ 5. exp Phobic disorders/ 6. (fear$ adj3 (air travel or animal$ or blood$ or buses or ((closed or public) adj2 space$) or crowd$ or dark$ or dental$ or dentist$ or dog$1 or dying or flight$ or fly or flying or height$ or hypochondriacal or injection$ or injur$ or lightening or movement$ or needle$ or negative evaluation or panic$ or performance or plane$ or snake$ or social or space$ or spider$ or sweat& or thunder$ or train$ or travel$ or tremble$ or water)).ti,ab. 7. (acrophob$ or agoraphob$ or agrophobi$ or ((anxiety$ or phobi$) adj2 neuros$) or anxiety disorders or claustrophob$ or Compul$ or emetophob$ or GAD or ((generalised or generalized or health) adj2 anxiety) or hypochondri$ or ((interpersonal or inter personal or social or speak$) adj3 (anxiety$ or avoid$ or fear$)) or kinesiophob$ or (specific adj2 (phobi$ or fear$)) or Obsess$ or OCD or (panic adj3 (attack$ or disorder$ or fear or symptoms)) or SAD or shyness).ti,ab. 8. anxiety.ti. 9. stress.ti. 10. anxiety.ti,ab. 11. 9 and 10 12. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 11 13. exp bibliotherapy/ 14. (audiotherapy or bibliotherapy or biblio therap$ or book$ or CD$ or computer$ or cyber$ or DVD or internet$ or interactive voice response or interapy or inter‐therapy or intertherapy or multimedia or multi media or online or on‐line or pamphlet or pamphlets or pc$ or pcs or (self adj (administered or desensiti$ or directed or exposure or help)) or tape or taped or video$ or web$ or www).ti,ab. 15. 13 or 14 16. (CBT or (cognitive adj2 behav$) or ((cognitive or behav$) adj3 (therap$ or intervention$ or program$ or restructur$)) or CT or desensiti$ or exposure or flooding or implosion or MCBT or mindfulness$ or metacognitive or mymct or modelling or relax$).ti,ab. 17. 15 and 16 18. (blues begone or caccbt or CALM or CAVE or ccbt or c cbt or (coping adj2 panic) or ffeducation or ff education or glasgow steps or internetff or internet ff or (living adj2 fear) or (living life adj3 full) or managing anxiety or moodgym or mood gym or netcope or net cope or nettff or nett ff or ocfighter or oc fighter or overcoming anxiety or overcoming obsessive or overcoming panic or overcoming shyness or (panic adj2 control) or (panic adj2 online) or (panic adj2 surfing) or positivestep or positive step or ((shyness or wellbeing) adj4 (program or programme)) or standaloneff or standalone ff or stop obsessing or stresspac or talk to me).ti,ab. 19. (bibliotherapy or self‐help or interapy or (internet‐based adj2 (intervention$ or management or self‐help or treatment$ or therapy or therapies or program$))).ti. 20. 17 or 18 or 19 21. 12 and 20 22. ((beating adj2 blues) or btstep$ or bt step$ or fearfighter or fear fighter).ti,ab. 23. 21 or 22 24. exp clinical trial/ 25. random$.af. 26. ((clinical$ adj2 control$) or cross over or crossover or dummy or experiment$ or factorial or mask$ or ((single$ or doubl$ or trebl$ or tripl$) adj2 blind) or (singleblind$ or doubleblind$ or trebleblind$ or tripleblind$) or placebo$ or trial or ((wait list or waitlist or waiting list or no treatment) adj (condition or control or group))).ti,ab. 27. 24 or 25 or 26 28. limit 27 to animal 29. limit 27 to animal studies 30. 28 or 29 31. limit 30 to humans 32. 30 not 31 33. 27 not 32 34. 23 and 33 35. remove duplicates from 34
Data and analyses
Comparison 1. Media‐delivered interventions compared to no intervention.
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1 Anxiety (any measure), self‐rated at post‐treatment | 76 | 4537 | Std. Mean Difference (Random, 95% CI) | 0.67 [0.55, 0.78] |
| 2 Anxiety (any measure), self‐rated at post‐treatment (type of control) | 76 | 4537 | Std. Mean Difference (Random, 95% CI) | 0.67 [0.55, 0.78] |
| 2.1 Adjunct | 1 | 93 | Std. Mean Difference (Random, 95% CI) | 0.33 [‐0.08, 0.75] |
| 2.2 Attention controls | 22 | 1028 | Std. Mean Difference (Random, 95% CI) | 0.65 [0.48, 0.82] |
| 2.3 Treatment as Usual | 7 | 745 | Std. Mean Difference (Random, 95% CI) | 0.21 [0.02, 0.40] |
| 2.4 Wait‐List | 46 | 2671 | Std. Mean Difference (Random, 95% CI) | 0.77 [0.61, 0.92] |
| 3 Anxiety (any measure), self‐rated at post‐treatment (by disorder) | 76 | 4537 | Std. Mean Difference (Random, 95% CI) | 0.67 [0.55, 0.78] |
| 3.1 GAD | 10 | 649 | Std. Mean Difference (Random, 95% CI) | 0.95 [0.44, 1.45] |
| 3.2 Health | 2 | 120 | Std. Mean Difference (Random, 95% CI) | 1.01 [0.24, 1.78] |
| 3.3 Mixed | 18 | 1376 | Std. Mean Difference (Random, 95% CI) | 0.36 [0.19, 0.52] |
| 3.4 OCD | 2 | 220 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.41, 0.95] |
| 3.5 Panic | 21 | 797 | Std. Mean Difference (Random, 95% CI) | 0.62 [0.45, 0.79] |
| 3.6 Social | 15 | 1152 | Std. Mean Difference (Random, 95% CI) | 0.73 [0.59, 0.87] |
| 3.7 Specific | 8 | 223 | Std. Mean Difference (Random, 95% CI) | 0.99 [0.50, 1.48] |
| 4 Anxiety (any measure), self‐rated at post‐treatment (by media) | 76 | 4537 | Std. Mean Difference (Random, 95% CI) | 0.67 [0.55, 0.78] |
| 4.1 Book | 27 | 1046 | Std. Mean Difference (Random, 95% CI) | 0.48 [0.30, 0.65] |
| 4.2 Computer | 8 | 458 | Std. Mean Difference (Random, 95% CI) | 0.69 [0.31, 1.07] |
| 4.3 Internet | 36 | 2522 | Std. Mean Difference (Random, 95% CI) | 0.79 [0.62, 0.96] |
| 4.4 Other | 5 | 511 | Std. Mean Difference (Random, 95% CI) | 0.51 [0.32, 0.71] |
| 5 Anxiety (any measure), self‐rated at post‐treatment (by therapy) | 76 | 4537 | Std. Mean Difference (Random, 95% CI) | 0.67 [0.55, 0.78] |
| 5.1 CBT | 56 | 3550 | Std. Mean Difference (Random, 95% CI) | 0.62 [0.51, 0.73] |
| 5.2 Exposure/ Desensitization | 13 | 448 | Std. Mean Difference (Random, 95% CI) | 0.79 [0.49, 1.09] |
| 5.3 Relaxation | 6 | 504 | Std. Mean Difference (Random, 95% CI) | 0.84 [‐0.06, 1.73] |
| 5.4 Self‐examination | 1 | 35 | Std. Mean Difference (Random, 95% CI) | 0.92 [0.22, 1.62] |
| 6 Anxiety (any measure), self‐rated at post‐treatment (by setting) | 75 | 4506 | Std. Mean Difference (Random, 95% CI) | 0.67 [0.55, 0.78] |
| 6.1 Advertising | 55 | 3438 | Std. Mean Difference (Random, 95% CI) | 0.77 [0.63, 0.90] |
| 6.2 Referral Only | 16 | 884 | Std. Mean Difference (Random, 95% CI) | 0.32 [0.14, 0.51] |
| 6.3 Other | 4 | 184 | Std. Mean Difference (Random, 95% CI) | 0.46 [0.10, 0.82] |
| 7 Anxiety (any measure), self‐rated at post‐treatment (sensitivity analysis for bias) | 76 | 4537 | Std. Mean Difference (Random, 95% CI) | 0.67 [0.55, 0.78] |
| 7.1 High or Unclear Risk for Incomplete Outcome Data | 30 | 1481 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.46, 0.90] |
| 7.2 Low Risk for Incomplete Outcome Data | 46 | 3056 | Std. Mean Difference (Random, 95% CI) | 0.66 [0.53, 0.79] |
| 8 Specific symptoms, self‐rated at post‐treatment | 59 | 3192 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.57, 0.80] |
| 9 Specific symptoms, self‐rated at post‐treatment (type of control) | 59 | 3192 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.57, 0.80] |
| 9.1 Adjunct | 1 | 93 | Std. Mean Difference (Random, 95% CI) | 0.31 [‐0.10, 0.73] |
| 9.2 Attention controls | 19 | 873 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.47, 0.89] |
| 9.3 Treatment as Usual | 2 | 118 | Std. Mean Difference (Random, 95% CI) | 0.02 [‐0.35, 0.40] |
| 9.4 Wait‐List | 37 | 2108 | Std. Mean Difference (Random, 95% CI) | 0.74 [0.60, 0.88] |
| 10 Specific symptoms, self‐rated at post‐treatment (by disorder) | 58 | 3201 | Std. Mean Difference (Random, 95% CI) | 0.69 [0.57, 0.80] |
| 10.1 GAD | 8 | 514 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.29, 1.07] |
| 10.2 Health | 2 | 120 | Std. Mean Difference (Random, 95% CI) | 0.85 [‐0.50, 2.21] |
| 10.3 Mixed | 4 | 231 | Std. Mean Difference (Random, 95% CI) | 0.21 [‐0.15, 0.57] |
| 10.4 OCD | 2 | 220 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.41, 0.95] |
| 10.5 Panic | 20 | 740 | Std. Mean Difference (Random, 95% CI) | 0.61 [0.43, 0.79] |
| 10.6 Social | 15 | 1153 | Std. Mean Difference (Random, 95% CI) | 0.76 [0.63, 0.89] |
| 10.7 Specific | 8 | 223 | Std. Mean Difference (Random, 95% CI) | 0.99 [0.50, 1.48] |
| 11 Specific symptoms, self‐rated at post‐treatment (by media) | 59 | 3192 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.57, 0.80] |
| 11.1 Book | 19 | 691 | Std. Mean Difference (Random, 95% CI) | 0.53 [0.32, 0.74] |
| 11.2 Computer | 7 | 261 | Std. Mean Difference (Random, 95% CI) | 0.79 [0.29, 1.28] |
| 11.3 Internet | 29 | 1829 | Std. Mean Difference (Random, 95% CI) | 0.77 [0.61, 0.92] |
| 11.4 Other | 4 | 411 | Std. Mean Difference (Random, 95% CI) | 0.60 [0.39, 0.82] |
| 12 Specific symptoms, self‐rated at post‐treatment (by therapy) | 59 | 3192 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.57, 0.80] |
| 12.1 CBT | 44 | 2662 | Std. Mean Difference (Random, 95% CI) | 0.67 [0.54, 0.80] |
| 12.2 Exposure/ Desensitization | 13 | 440 | Std. Mean Difference (Random, 95% CI) | 0.77 [0.46, 1.08] |
| 12.3 Muscle relaxation | 2 | 90 | Std. Mean Difference (Random, 95% CI) | 0.66 [0.22, 1.09] |
| 13 Specific symptoms, self‐rated at post‐treatment (by setting) | 59 | 3192 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.57, 0.80] |
| 13.1 Advertising | 48 | 2749 | Std. Mean Difference (Random, 95% CI) | 0.74 [0.62, 0.86] |
| 13.2 Referral Only | 9 | 350 | Std. Mean Difference (Random, 95% CI) | 0.38 [0.09, 0.67] |
| 13.3 Other | 2 | 93 | Std. Mean Difference (Random, 95% CI) | 0.53 [‐0.25, 1.31] |
| 14 Specific symptoms, self‐rated at post‐treatment (sensitivity analysis for bias) | 59 | 3192 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.57, 0.80] |
| 14.1 High or Unclear Risk for Incomplete Outcome Data | 23 | 949 | Std. Mean Difference (Random, 95% CI) | 0.60 [0.44, 0.76] |
| 14.2 Low Risk for Incomplete Outcome Data | 36 | 2243 | Std. Mean Difference (Random, 95% CI) | 0.73 [0.57, 0.88] |
| 15 Specific symptoms, self‐rated at post‐treatment (studies also reporting clinician rated) | 59 | 3192 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.57, 0.80] |
| 15.1 Not reporting clinician rated | 47 | 2674 | Std. Mean Difference (Random, 95% CI) | 0.68 [0.55, 0.81] |
| 15.2 Also reporting clinician rated | 12 | 518 | Std. Mean Difference (Random, 95% CI) | 0.70 [0.46, 0.95] |
| 16 Specific symptoms, clinician‐rated at post‐treatment | 15 | 629 | Std. Mean Difference (Random, 95% CI) | 1.04 [0.50, 1.58] |
| 17 Specific symptoms, clinician‐rated at post‐treatment | 15 | 629 | Std. Mean Difference (Random, 95% CI) | 1.04 [0.50, 1.58] |
| 17.1 Not reporting self‐rated | 3 | 112 | Std. Mean Difference (Random, 95% CI) | 1.39 [0.97, 1.80] |
| 17.2 Also reporting self‐rated | 12 | 517 | Std. Mean Difference (Random, 95% CI) | 0.97 [0.32, 1.61] |
| 18 General symptoms, self‐rated at post‐treatment | 48 | 3101 | Std. Mean Difference (Random, 95% CI) | 0.58 [0.43, 0.73] |
| 19 Behavioural Test (level), clinician‐rated at post‐treatment | 7 | 250 | Std. Mean Difference (Random, 95% CI) | 1.11 [0.36, 1.87] |
| 20 Behavioural Test (symptoms), self‐rated at post‐treatment | 5 | 196 | Std. Mean Difference (Random, 95% CI) | 0.59 [‐0.33, 1.51] |
| 21 Response (specific), self‐rated at post‐treatment | 21 | 1547 | Risk Ratio (M‐H, Random, 95% CI) | 2.34 [1.81, 3.03] |
| 22 Response (specific), self‐rated at post‐treatment (type of control) | 21 | 1547 | Risk Ratio (M‐H, Random, 95% CI) | 2.34 [1.81, 3.03] |
| 22.1 Adjunct | 1 | 95 | Risk Ratio (M‐H, Random, 95% CI) | 1.43 [0.91, 2.25] |
| 22.2 Attention controls | 7 | 526 | Risk Ratio (M‐H, Random, 95% CI) | 1.85 [1.39, 2.45] |
| 22.3 Treatment as Usual | 1 | 120 | Risk Ratio (M‐H, Random, 95% CI) | 1.33 [0.49, 3.61] |
| 22.4 Wait‐List | 12 | 806 | Risk Ratio (M‐H, Random, 95% CI) | 3.18 [2.16, 4.68] |
| 23 Response (specific), self‐rated at post‐treatment (by disorder) | 21 | 1751 | Risk Ratio (M‐H, Random, 95% CI) | 2.42 [1.88, 3.12] |
| 23.1 GAD | 4 | 342 | Risk Ratio (M‐H, Random, 95% CI) | 4.60 [2.75, 7.68] |
| 23.2 Mixed | 2 | 161 | Risk Ratio (M‐H, Random, 95% CI) | 2.00 [1.23, 3.24] |
| 23.3 OCD | 1 | 149 | Risk Ratio (M‐H, Random, 95% CI) | 2.36 [1.16, 4.82] |
| 23.4 Panic | 9 | 384 | Risk Ratio (M‐H, Random, 95% CI) | 1.73 [1.29, 2.30] |
| 23.5 Social | 4 | 695 | Risk Ratio (M‐H, Random, 95% CI) | 2.85 [1.59, 5.11] |
| 23.6 Specific | 1 | 20 | Risk Ratio (M‐H, Random, 95% CI) | 17.50 [1.16, 263.03] |
| 24 Response (specific), self‐rated at post‐treatment (by media) | 21 | 1751 | Risk Ratio (M‐H, Random, 95% CI) | 2.42 [1.88, 3.12] |
| 24.1 Book | 7 | 250 | Risk Ratio (M‐H, Random, 95% CI) | 1.85 [1.36, 2.52] |
| 24.2 Computer | 2 | 115 | Risk Ratio (M‐H, Random, 95% CI) | 3.75 [0.25, 56.38] |
| 24.3 Internet | 8 | 882 | Risk Ratio (M‐H, Random, 95% CI) | 3.76 [2.84, 4.97] |
| 24.4 Other | 4 | 504 | Risk Ratio (M‐H, Random, 95% CI) | 1.79 [1.08, 2.99] |
| 25 Response (specific), self‐rated at post‐treatment (by therapy) | 21 | 1547 | Risk Ratio (M‐H, Random, 95% CI) | 2.34 [1.81, 3.03] |
| 25.1 Applied relaxation | 0 | 0 | Risk Ratio (M‐H, Random, 95% CI) | 0.0 [0.0, 0.0] |
| 25.2 CBT | 19 | 1378 | Risk Ratio (M‐H, Random, 95% CI) | 2.30 [1.76, 3.01] |
| 25.3 Exposure/ Desensitization | 2 | 169 | Risk Ratio (M‐H, Random, 95% CI) | 4.36 [0.63, 29.98] |
| 25.4 Muscle relaxation | 0 | 0 | Risk Ratio (M‐H, Random, 95% CI) | 0.0 [0.0, 0.0] |
| 25.5 Self‐examination | 0 | 0 | Risk Ratio (M‐H, Random, 95% CI) | 0.0 [0.0, 0.0] |
| 26 Response (specific), self‐rated at post‐treatment (by setting) | 21 | 1547 | Risk Ratio (M‐H, Random, 95% CI) | 2.34 [1.81, 3.03] |
| 26.1 Advertising | 19 | 1386 | Risk Ratio (M‐H, Random, 95% CI) | 2.43 [1.82, 3.25] |
| 26.2 Referral Only | 2 | 161 | Risk Ratio (M‐H, Random, 95% CI) | 2.00 [1.23, 3.24] |
| 26.3 Other | 0 | 0 | Risk Ratio (M‐H, Random, 95% CI) | 0.0 [0.0, 0.0] |
| 27 Response (specific), clinician‐rated at post‐treatment | 11 | 922 | Risk Ratio (M‐H, Random, 95% CI) | 4.90 [3.12, 7.68] |
| 28 Response (general), self‐rated at post‐treatment | 8 | 622 | Risk Ratio (M‐H, Random, 95% CI) | 2.11 [1.13, 3.93] |
| 29 Recovery, clinician‐rated at post‐treatment | 9 | 605 | Risk Difference (M‐H, Random, 95% CI) | 0.40 [0.20, 0.60] |
| 30 Depression, self‐rated at post‐treatment | 51 | 3682 | Std. Mean Difference (Random, 95% CI) | 0.47 [0.36, 0.58] |
| 31 Depression, clinician‐rated at post‐treatment | 1 | 50 | Std. Mean Difference (Random, 95% CI) | 0.06 [‐0.49, 0.60] |
| 32 Depression improvement, self‐rated at post‐treatment | 5 | 224 | Risk Ratio (M‐H, Random, 95% CI) | 2.64 [1.36, 5.14] |
| 33 Disability, self‐rated at post‐treatment | 20 | 1629 | Std. Mean Difference (Random, 95% CI) | 0.48 [0.33, 0.63] |
| 34 Disability, clinician‐rated at post‐treatment | 5 | 293 | Std. Mean Difference (Random, 95% CI) | 0.56 [‐0.01, 1.14] |
| 35 Quality of Life, self‐rated at post‐treatment | 18 | 1344 | Std. Mean Difference (Random, 95% CI) | 0.36 [0.22, 0.49] |
| 36 Dropout at post‐treatment | 78 | 6059 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.94, 0.99] |
| 37 Anxiety (any measure), self‐rated at follow‐up | 15 | 684 | Std. Mean Difference (Random, 95% CI) | 0.49 [0.24, 0.75] |
| 38 Specific symptoms, self‐rated at follow‐up | 12 | 439 | Std. Mean Difference (Random, 95% CI) | 0.61 [0.27, 0.94] |
| 39 Specific symptoms, clinician‐rated at follow‐up | 5 | 98 | Std. Mean Difference (Random, 95% CI) | 1.12 [0.70, 1.53] |
| 40 General symptoms, self‐rated at follow‐up | 9 | 569 | Std. Mean Difference (Random, 95% CI) | 0.22 [0.06, 0.39] |
| 41 Behavioural Test (level), clinician‐rated at follow‐up | 1 | 30 | Std. Mean Difference (Random, 95% CI) | 1.23 [0.47, 1.99] |
| 42 Behavioural Test (symptoms), self‐rated at follow‐up | 1 | 30 | Std. Mean Difference (Random, 95% CI) | 0.60 [‐0.11, 1.31] |
| 43 Response (specific), self‐rated at follow‐up | 2 | 128 | Risk Ratio (M‐H, Random, 95% CI) | 2.12 [1.18, 3.79] |
| 44 Response (specific), clinician‐rated at follow‐up | 1 | 23 | Risk Ratio (M‐H, Random, 95% CI) | 3.93 [0.21, 73.71] |
| 45 Response (general), self‐rated at follow‐up | 1 | 95 | Risk Ratio (M‐H, Random, 95% CI) | 0.97 [0.51, 1.84] |
| 46 Recovery, clinician‐rated at follow‐up | 1 | 117 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.64, 1.28] |
| 47 Depression, self‐rated at follow‐up | 7 | 526 | Std. Mean Difference (Random, 95% CI) | 0.28 [0.05, 0.52] |
| 48 Depression, clinician‐rated at follow‐up | 1 | 50 | Std. Mean Difference (Random, 95% CI) | 0.32 [‐0.23, 0.87] |
| 49 Disability, self‐rated at follow‐up | 7 | 513 | Std. Mean Difference (Random, 95% CI) | 0.21 [‐0.15, 0.57] |
| 50 Disability, clinician‐rated at follow‐up | 3 | 108 | Std. Mean Difference (Random, 95% CI) | 0.53 [0.14, 0.93] |
| 51 Quality of Life, self‐rated at follow‐up | 3 | 211 | Std. Mean Difference (Random, 95% CI) | 0.08 [‐0.19, 0.35] |
| 52 Anxiety (any measure), self‐rated at >6m | 5 | 287 | Std. Mean Difference (Random, 95% CI) | 0.18 [‐0.15, 0.52] |
| 53 Specific symptoms, self‐rated at >6m | 5 | 287 | Std. Mean Difference (Random, 95% CI) | 0.20 [‐0.11, 0.51] |
| 54 General symptoms, self‐rated at >6m | 2 | 194 | Std. Mean Difference (Random, 95% CI) | ‐0.07 [‐0.63, 0.49] |
| 55 Response (specific), self‐rated at >6m | 2 | 148 | Risk Ratio (Random, 95% CI) | 1.51 [0.67, 3.36] |
| 56 Depression, self‐rated at >6m | 2 | 194 | Std. Mean Difference (Random, 95% CI) | ‐0.25 [‐0.58, 0.08] |
| 57 Disability, self‐rated at >6m | 3 | 147 | Std. Mean Difference (Random, 95% CI) | 0.14 [‐0.33, 0.60] |
| 58 Quality of Life, self‐rated at >6m | 1 | 115 | Std. Mean Difference (Random, 95% CI) | ‐0.06 [‐0.48, 0.36] |
1.1. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 1 Anxiety (any measure), self‐rated at post‐treatment.
1.2. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 2 Anxiety (any measure), self‐rated at post‐treatment (type of control).
1.3. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 3 Anxiety (any measure), self‐rated at post‐treatment (by disorder).
1.4. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 4 Anxiety (any measure), self‐rated at post‐treatment (by media).
1.5. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 5 Anxiety (any measure), self‐rated at post‐treatment (by therapy).
1.6. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 6 Anxiety (any measure), self‐rated at post‐treatment (by setting).
1.7. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 7 Anxiety (any measure), self‐rated at post‐treatment (sensitivity analysis for bias).
1.8. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 8 Specific symptoms, self‐rated at post‐treatment.
1.9. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 9 Specific symptoms, self‐rated at post‐treatment (type of control).
1.10. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 10 Specific symptoms, self‐rated at post‐treatment (by disorder).
1.11. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 11 Specific symptoms, self‐rated at post‐treatment (by media).
1.12. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 12 Specific symptoms, self‐rated at post‐treatment (by therapy).
1.13. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 13 Specific symptoms, self‐rated at post‐treatment (by setting).
1.14. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 14 Specific symptoms, self‐rated at post‐treatment (sensitivity analysis for bias).
1.15. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 15 Specific symptoms, self‐rated at post‐treatment (studies also reporting clinician rated).
1.16. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 16 Specific symptoms, clinician‐rated at post‐treatment.
1.17. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 17 Specific symptoms, clinician‐rated at post‐treatment.
1.18. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 18 General symptoms, self‐rated at post‐treatment.
1.19. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 19 Behavioural Test (level), clinician‐rated at post‐treatment.
1.20. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 20 Behavioural Test (symptoms), self‐rated at post‐treatment.
1.21. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 21 Response (specific), self‐rated at post‐treatment.
1.22. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 22 Response (specific), self‐rated at post‐treatment (type of control).
1.23. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 23 Response (specific), self‐rated at post‐treatment (by disorder).
1.24. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 24 Response (specific), self‐rated at post‐treatment (by media).
1.25. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 25 Response (specific), self‐rated at post‐treatment (by therapy).
1.26. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 26 Response (specific), self‐rated at post‐treatment (by setting).
1.27. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 27 Response (specific), clinician‐rated at post‐treatment.
1.28. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 28 Response (general), self‐rated at post‐treatment.
1.29. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 29 Recovery, clinician‐rated at post‐treatment.
1.30. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 30 Depression, self‐rated at post‐treatment.
1.31. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 31 Depression, clinician‐rated at post‐treatment.
1.32. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 32 Depression improvement, self‐rated at post‐treatment.
1.33. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 33 Disability, self‐rated at post‐treatment.
1.34. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 34 Disability, clinician‐rated at post‐treatment.
1.35. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 35 Quality of Life, self‐rated at post‐treatment.
1.36. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 36 Dropout at post‐treatment.
1.37. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 37 Anxiety (any measure), self‐rated at follow‐up.
1.38. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 38 Specific symptoms, self‐rated at follow‐up.
1.39. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 39 Specific symptoms, clinician‐rated at follow‐up.
1.40. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 40 General symptoms, self‐rated at follow‐up.
1.41. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 41 Behavioural Test (level), clinician‐rated at follow‐up.
1.42. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 42 Behavioural Test (symptoms), self‐rated at follow‐up.
1.43. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 43 Response (specific), self‐rated at follow‐up.
1.44. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 44 Response (specific), clinician‐rated at follow‐up.
1.45. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 45 Response (general), self‐rated at follow‐up.
1.46. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 46 Recovery, clinician‐rated at follow‐up.
1.47. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 47 Depression, self‐rated at follow‐up.
1.48. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 48 Depression, clinician‐rated at follow‐up.
1.49. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 49 Disability, self‐rated at follow‐up.
1.50. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 50 Disability, clinician‐rated at follow‐up.
1.51. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 51 Quality of Life, self‐rated at follow‐up.
1.52. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 52 Anxiety (any measure), self‐rated at >6m.
1.53. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 53 Specific symptoms, self‐rated at >6m.
1.54. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 54 General symptoms, self‐rated at >6m.
1.55. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 55 Response (specific), self‐rated at >6m.
1.56. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 56 Depression, self‐rated at >6m.
1.57. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 57 Disability, self‐rated at >6m.
1.58. Analysis.
Comparison 1 Media‐delivered interventions compared to no intervention, Outcome 58 Quality of Life, self‐rated at >6m.
Comparison 2. Media‐delivered interventions compared to face‐to‐face interventions.
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1 Anxiety (any measure), self‐rated at post‐treatment | 24 | 1360 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.36, ‐0.09] |
| 2 Anxiety (any measure), self‐rated at post‐treatment (group versus individual) | 24 | 1360 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.36, ‐0.09] |
| 2.1 Group CBT | 5 | 477 | Std. Mean Difference (Random, 95% CI) | ‐0.18 [‐0.44, 0.09] |
| 2.2 Individual CBT | 9 | 549 | Std. Mean Difference (Random, 95% CI) | ‐0.17 [‐0.34, 0.00] |
| 2.3 Individual Exposure | 10 | 334 | Std. Mean Difference (Random, 95% CI) | ‐0.39 [‐0.65, ‐0.13] |
| 3 Anxiety (any measure), self‐rated at post‐treatment (by disorder) | 24 | 1360 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.36, ‐0.09] |
| 3.1 Mixed | 2 | 165 | Std. Mean Difference (Random, 95% CI) | ‐0.25 [‐0.56, 0.05] |
| 3.2 OCD | 2 | 147 | Std. Mean Difference (Random, 95% CI) | ‐0.26 [‐0.59, 0.06] |
| 3.3 Panic | 8 | 430 | Std. Mean Difference (Random, 95% CI) | ‐0.27 [‐0.51, ‐0.03] |
| 3.4 Social | 4 | 373 | Std. Mean Difference (Random, 95% CI) | 0.02 [‐0.18, 0.22] |
| 3.5 Specific | 8 | 245 | Std. Mean Difference (Random, 95% CI) | ‐0.39 [‐0.73, ‐0.06] |
| 4 Anxiety (any measure), self‐rated at post‐treatment (by media) | 24 | 1360 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.36, ‐0.09] |
| 4.1 Book | 10 | 535 | Std. Mean Difference (Random, 95% CI) | ‐0.34 [‐0.60, ‐0.08] |
| 4.2 Computer | 4 | 136 | Std. Mean Difference (Random, 95% CI) | ‐0.38 [‐0.71, ‐0.04] |
| 4.3 Internet | 7 | 519 | Std. Mean Difference (Random, 95% CI) | ‐0.05 [‐0.22, 0.12] |
| 4.4 Other | 3 | 170 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.53, 0.07] |
| 5 Anxiety (any measure), self‐rated at post‐treatment (by therapy) | 24 | 1360 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.36, ‐0.09] |
| 5.1 CBT | 13 | 916 | Std. Mean Difference (Random, 95% CI) | ‐0.16 [‐0.31, ‐0.00] |
| 5.2 Exposure/ Desensitization | 10 | 419 | Std. Mean Difference (Random, 95% CI) | ‐0.37 [‐0.62, ‐0.13] |
| 5.3 Muscle relaxation | 1 | 25 | Std. Mean Difference (Random, 95% CI) | ‐0.14 [‐0.92, 0.65] |
| 6 Anxiety (any measure), self‐rated at post‐treatment (by setting) | 24 | 1360 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.36, ‐0.09] |
| 6.1 Advertising | 17 | 916 | Std. Mean Difference (Random, 95% CI) | ‐0.15 [‐0.32, 0.02] |
| 6.2 Referral Only | 7 | 444 | Std. Mean Difference (Random, 95% CI) | ‐0.37 [‐0.56, ‐0.18] |
| 7 Anxiety (any measure), self‐rated at post‐treatment (sensitivity analysis for bias) | 24 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.36, ‐0.09] | |
| 7.1 High or Unclear Risk for Incomplete Outcome Data | 11 | Std. Mean Difference (Random, 95% CI) | ‐0.28 [‐0.44, ‐0.13] | |
| 7.2 Low Risk for Incomplete Outcome Data | 13 | Std. Mean Difference (Random, 95% CI) | ‐0.18 [‐0.40, 0.04] | |
| 8 Specific symptoms, self‐rated at post‐treatment | 23 | 1255 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.37, ‐0.10] |
| 9 Specific symptoms, self‐rated at post‐treatment (group versus individual) | 23 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.37, ‐0.10] | |
| 9.1 Group CBT | 4 | Std. Mean Difference (Random, 95% CI) | ‐0.17 [‐0.52, 0.19] | |
| 9.2 Individual CBT | 9 | Std. Mean Difference (Random, 95% CI) | ‐0.18 [‐0.35, ‐0.02] | |
| 9.3 Individual Exposure | 10 | Std. Mean Difference (Random, 95% CI) | ‐0.40 [‐0.65, ‐0.14] | |
| 10 Specific symptoms, self‐rated at post‐treatment (by disorder) | 23 | 1255 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.37, ‐0.10] |
| 10.1 Mixed | 2 | 165 | Std. Mean Difference (Random, 95% CI) | ‐0.24 [‐0.54, 0.07] |
| 10.2 OCD | 2 | 145 | Std. Mean Difference (Random, 95% CI) | ‐0.29 [‐0.62, 0.03] |
| 10.3 Panic | 7 | 327 | Std. Mean Difference (Random, 95% CI) | ‐0.30 [‐0.56, ‐0.04] |
| 10.4 Social | 4 | 373 | Std. Mean Difference (Random, 95% CI) | 0.03 [‐0.18, 0.23] |
| 10.5 Specific | 8 | 245 | Std. Mean Difference (Random, 95% CI) | ‐0.40 [‐0.74, ‐0.06] |
| 11 Specific symptoms, self‐rated at post‐treatment (by media) | 22 | 1275 | Std. Mean Difference (Random, 95% CI) | ‐0.26 [‐0.39, ‐0.12] |
| 11.1 Book | 10 | 553 | Std. Mean Difference (Random, 95% CI) | ‐0.42 [‐0.65, ‐0.20] |
| 11.2 Computer | 4 | 136 | Std. Mean Difference (Random, 95% CI) | ‐0.38 [‐0.71, ‐0.04] |
| 11.3 Internet | 6 | 416 | Std. Mean Difference (Random, 95% CI) | 0.01 [‐0.18, 0.20] |
| 11.4 Other | 3 | 170 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.54, 0.07] |
| 12 Specific symptoms, self‐rated at post‐treatment (by therapy) | 23 | 1255 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.37, ‐0.10] |
| 12.1 CBT | 12 | 811 | Std. Mean Difference (Random, 95% CI) | ‐0.16 [‐0.33, 0.01] |
| 12.2 Exposure/ Desensitization | 10 | 419 | Std. Mean Difference (Random, 95% CI) | ‐0.38 [‐0.62, ‐0.14] |
| 12.3 Muscle relaxation | 1 | 25 | Std. Mean Difference (Random, 95% CI) | ‐0.14 [‐0.92, 0.65] |
| 13 Specific symptoms, self‐rated at post‐treatment (by setting) | 23 | 1255 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.37, ‐0.10] |
| 13.1 Advertising | 17 | 917 | Std. Mean Difference (Random, 95% CI) | ‐0.16 [‐0.32, 0.00] |
| 13.2 Referral Only | 6 | 338 | Std. Mean Difference (Random, 95% CI) | ‐0.42 [‐0.64, ‐0.21] |
| 14 Specific symptoms, self‐rated at post‐treatment (sensitivity analysis for bias) | 23 | 1255 | Std. Mean Difference (Random, 95% CI) | ‐0.23 [‐0.37, ‐0.10] |
| 14.1 High or Unclear Risk for Incomplete Outcome Data | 10 | 523 | Std. Mean Difference (Random, 95% CI) | ‐0.29 [‐0.47, ‐0.12] |
| 14.2 Low Risk for Incomplete Outcome Data | 13 | 732 | Std. Mean Difference (Random, 95% CI) | ‐0.20 [‐0.41, 0.02] |
| 15 Specific symptoms, clinician‐rated at post‐treatment | 6 | 418 | Std. Mean Difference (Random, 95% CI) | ‐0.13 [‐0.33, 0.06] |
| 16 General symptoms, self‐rated at post‐treatment | 11 | 627 | Std. Mean Difference (Random, 95% CI) | ‐0.08 [‐0.36, 0.20] |
| 17 Behavioural Test (level), clinician‐rated at post‐treatment | 5 | 211 | Std. Mean Difference (Random, 95% CI) | ‐0.44 [‐0.76, ‐0.13] |
| 18 Behavioural Test (symptoms), self‐rated at post‐treatment | 5 | 209 | Std. Mean Difference (Random, 95% CI) | ‐0.57 [‐1.35, 0.21] |
| 19 Response (specific), self‐rated at post‐treatment | 10 | 575 | Risk Ratio (M‐H, Random, 95% CI) | 0.78 [0.56, 1.09] |
| 20 Response (specific), self‐rated at post‐treatment (group versus individual) | 10 | 575 | Risk Ratio (M‐H, Random, 95% CI) | 0.78 [0.56, 1.09] |
| 20.1 Group CBT | 1 | 126 | Risk Ratio (M‐H, Random, 95% CI) | 1.61 [1.07, 2.44] |
| 20.2 Individual CBT | 7 | 382 | Risk Ratio (M‐H, Random, 95% CI) | 0.73 [0.53, 1.01] |
| 20.3 Individual Exposure | 2 | 67 | Risk Ratio (M‐H, Random, 95% CI) | 0.39 [0.02, 7.29] |
| 21 Response (specific), self‐rated at post‐treatment (by disorder) | 10 | 575 | Risk Ratio (M‐H, Random, 95% CI) | 0.78 [0.56, 1.09] |
| 21.1 OCD | 3 | 217 | Risk Ratio (M‐H, Random, 95% CI) | 0.59 [0.40, 0.87] |
| 21.2 Panic | 4 | 165 | Risk Ratio (M‐H, Random, 95% CI) | 0.82 [0.55, 1.23] |
| 21.3 Social | 1 | 126 | Risk Ratio (M‐H, Random, 95% CI) | 1.61 [1.07, 2.44] |
| 21.4 Specific | 2 | 67 | Risk Ratio (M‐H, Random, 95% CI) | 0.39 [0.02, 7.29] |
| 22 Response (specific), self‐rated at post‐treatment (by media) | 10 | 575 | Risk Ratio (M‐H, Random, 95% CI) | 0.78 [0.56, 1.09] |
| 22.1 Book | 6 | 224 | Risk Ratio (M‐H, Random, 95% CI) | 0.58 [0.30, 1.10] |
| 22.2 Computer | 1 | 33 | Risk Ratio (M‐H, Random, 95% CI) | 1.06 [0.74, 1.52] |
| 22.3 Internet | 2 | 175 | Risk Ratio (M‐H, Random, 95% CI) | 1.17 [0.61, 2.25] |
| 22.4 Other | 1 | 143 | Risk Ratio (M‐H, Random, 95% CI) | 0.61 [0.39, 0.95] |
| 23 Response (specific), self‐rated at post‐treatment (by therapy) | 10 | 575 | Risk Ratio (M‐H, Random, 95% CI) | 0.78 [0.56, 1.09] |
| 23.1 CBT | 7 | 365 | Risk Ratio (M‐H, Random, 95% CI) | 0.87 [0.60, 1.26] |
| 23.2 Exposure/ Desensitization | 3 | 210 | Risk Ratio (M‐H, Random, 95% CI) | 0.54 [0.22, 1.34] |
| 24 Response (specific), self‐rated at post‐treatment (by setting) | 10 | 575 | Risk Ratio (M‐H, Random, 95% CI) | 0.78 [0.56, 1.09] |
| 24.1 Advertising | 7 | 430 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.64, 1.27] |
| 24.2 Referral Only | 3 | 145 | Risk Ratio (M‐H, Random, 95% CI) | 0.48 [0.30, 0.76] |
| 25 Response (specific), clinician‐rated at post‐treatment | 9 | 663 | Risk Ratio (M‐H, Random, 95% CI) | 0.49 [0.31, 0.77] |
| 26 Response (general), self‐rated at post‐treatment | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 27 Recovery, clinician‐rated at post‐treatment | 6 | 587 | Risk Ratio (M‐H, Random, 95% CI) | 1.05 [0.88, 1.24] |
| 28 Depression, self‐rated at post‐treatment | 13 | 906 | Std. Mean Difference (Random, 95% CI) | ‐0.01 [‐0.22, 0.21] |
| 29 Depression, clinician‐rated at post‐treatment | 1 | Std. Mean Difference (Random, 95% CI) | Totals not selected | |
| 30 Depression improvement, self‐rated at post‐treatment | 2 | 73 | Risk Ratio (M‐H, Random, 95% CI) | 1.21 [0.74, 1.97] |
| 31 Disability, self‐rated at post‐treatment | 10 | 670 | Std. Mean Difference (Random, 95% CI) | ‐0.07 [‐0.33, 0.20] |
| 32 Disability, clinician‐rated at post‐treatment | 3 | 200 | Std. Mean Difference (Random, 95% CI) | 0.24 [‐0.04, 0.52] |
| 33 Quality of Life, self‐rated at post‐treatment | 4 | 282 | Std. Mean Difference (Random, 95% CI) | 0.08 [‐0.23, 0.38] |
| 34 Dropout at post‐treatment | 28 | 1852 | Risk Ratio (M‐H, Random, 95% CI) | 0.99 [0.95, 1.03] |
| 35 Anxiety (any measure), self‐rated at follow‐up | 11 | 677 | Std. Mean Difference (Random, 95% CI) | ‐0.14 [‐0.30, 0.01] |
| 36 Specific symptoms, self‐rated at follow‐up | 10 | 573 | Std. Mean Difference (Random, 95% CI) | ‐0.15 [‐0.31, 0.02] |
| 37 Specific symptoms, clinician‐rated at follow‐up | 3 | 185 | Std. Mean Difference (Random, 95% CI) | ‐0.19 [‐0.69, 0.30] |
| 38 General symptoms, self‐rated at follow‐up | 5 | 308 | Std. Mean Difference (Random, 95% CI) | ‐0.10 [‐0.30, 0.09] |
| 39 Behavioural Test (level), clinician‐rated at follow‐up | 2 | 60 | Std. Mean Difference (Random, 95% CI) | ‐0.02 [‐0.74, 0.71] |
| 40 Behavioural Test (symptoms), self‐rated at follow‐up | 1 | Std. Mean Difference (Random, 95% CI) | Totals not selected | |
| 41 Response (specific), self‐rated at follow‐up | 4 | 224 | Risk Ratio (M‐H, Random, 95% CI) | 0.99 [0.73, 1.35] |
| 42 Response (specific), clinician‐rated at follow‐up | 3 | 280 | Risk Ratio (M‐H, Random, 95% CI) | 1.10 [0.83, 1.45] |
| 43 Recovery, clinician‐rated at follow‐up | 3 | 354 | Risk Ratio (M‐H, Random, 95% CI) | 1.04 [0.70, 1.56] |
| 44 Depression, self‐rated at follow‐up | 5 | 403 | Std. Mean Difference (Random, 95% CI) | 0.09 [‐0.19, 0.36] |
| 45 Depression, clinician‐rated at follow‐up | 1 | Std. Mean Difference (Random, 95% CI) | Totals not selected | |
| 46 Depression improvement, self‐rated at follow‐up | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 47 Disability, self‐rated at follow‐up | 5 | 337 | Std. Mean Difference (Random, 95% CI) | ‐0.10 [‐0.39, 0.19] |
| 48 Disability, clinician‐rated at follow‐up | 2 | 145 | Std. Mean Difference (Random, 95% CI) | 0.18 [‐0.30, 0.65] |
| 49 Quality of Life, self‐rated at follow‐up | 2 | 143 | Std. Mean Difference (Random, 95% CI) | 0.40 [0.07, 0.73] |
| 50 Anxiety (any measure), self‐rated at >6m | 8 | 423 | Std. Mean Difference (Random, 95% CI) | ‐0.16 [‐0.50, 0.18] |
| 51 Specific symptoms, self‐rated at >6m | 8 | 423 | Std. Mean Difference (Random, 95% CI) | ‐0.20 [‐0.54, 0.14] |
| 52 Specific symptoms, clinician‐rated at >6m | 1 | Std. Mean Difference (Random, 95% CI) | Totals not selected | |
| 53 General symptoms, self‐rated at >6m | 4 | 241 | Std. Mean Difference (Random, 95% CI) | 0.04 [‐0.22, 0.30] |
| 54 Behavioural Test (level), clinician‐rated at >6m | 2 | 122 | Std. Mean Difference (Random, 95% CI) | ‐0.11 [‐0.97, 0.76] |
| 55 Behavioural Test (symptoms), self‐rated at >6m | 3 | 162 | Std. Mean Difference (Random, 95% CI) | ‐0.46 [‐1.19, 0.27] |
| 56 Response (specific), self‐rated at >6m | 3 | 116 | Risk Ratio (M‐H, Random, 95% CI) | 0.58 [0.20, 1.64] |
| 57 Response (specific), clinician‐rated at >6m | 2 | 82 | Risk Ratio (M‐H, Random, 95% CI) | 0.54 [0.16, 1.80] |
| 58 Response (general), self‐rated at >6m | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 59 Recovery, clinician‐rated at >6m | 2 | 147 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.64, 1.25] |
| 60 Depression, self‐rated at >6m | 5 | 339 | Std. Mean Difference (Random, 95% CI) | 0.08 [‐0.14, 0.30] |
| 61 Depression improvement, self‐rated at >6m | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 62 Disability, self‐rated at >6m | 3 | 242 | Std. Mean Difference (Random, 95% CI) | ‐0.21 [‐0.47, 0.04] |
| 63 Quality of Life, self‐rated at >6m | 1 | Std. Mean Difference (Random, 95% CI) | Totals not selected |
2.1. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 1 Anxiety (any measure), self‐rated at post‐treatment.
2.2. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 2 Anxiety (any measure), self‐rated at post‐treatment (group versus individual).
2.3. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 3 Anxiety (any measure), self‐rated at post‐treatment (by disorder).
2.4. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 4 Anxiety (any measure), self‐rated at post‐treatment (by media).
2.5. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 5 Anxiety (any measure), self‐rated at post‐treatment (by therapy).
2.6. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 6 Anxiety (any measure), self‐rated at post‐treatment (by setting).
2.7. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 7 Anxiety (any measure), self‐rated at post‐treatment (sensitivity analysis for bias).
2.8. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 8 Specific symptoms, self‐rated at post‐treatment.
2.9. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 9 Specific symptoms, self‐rated at post‐treatment (group versus individual).
2.10. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 10 Specific symptoms, self‐rated at post‐treatment (by disorder).
2.11. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 11 Specific symptoms, self‐rated at post‐treatment (by media).
2.12. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 12 Specific symptoms, self‐rated at post‐treatment (by therapy).
2.13. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 13 Specific symptoms, self‐rated at post‐treatment (by setting).
2.14. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 14 Specific symptoms, self‐rated at post‐treatment (sensitivity analysis for bias).
2.15. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 15 Specific symptoms, clinician‐rated at post‐treatment.
2.16. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 16 General symptoms, self‐rated at post‐treatment.
2.17. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 17 Behavioural Test (level), clinician‐rated at post‐treatment.
2.18. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 18 Behavioural Test (symptoms), self‐rated at post‐treatment.
2.19. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 19 Response (specific), self‐rated at post‐treatment.
2.20. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 20 Response (specific), self‐rated at post‐treatment (group versus individual).
2.21. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 21 Response (specific), self‐rated at post‐treatment (by disorder).
2.22. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 22 Response (specific), self‐rated at post‐treatment (by media).
2.23. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 23 Response (specific), self‐rated at post‐treatment (by therapy).
2.24. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 24 Response (specific), self‐rated at post‐treatment (by setting).
2.25. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 25 Response (specific), clinician‐rated at post‐treatment.
2.26. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 26 Response (general), self‐rated at post‐treatment.
2.27. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 27 Recovery, clinician‐rated at post‐treatment.
2.28. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 28 Depression, self‐rated at post‐treatment.
2.29. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 29 Depression, clinician‐rated at post‐treatment.
2.30. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 30 Depression improvement, self‐rated at post‐treatment.
2.31. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 31 Disability, self‐rated at post‐treatment.
2.32. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 32 Disability, clinician‐rated at post‐treatment.
2.33. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 33 Quality of Life, self‐rated at post‐treatment.
2.34. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 34 Dropout at post‐treatment.
2.35. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 35 Anxiety (any measure), self‐rated at follow‐up.
2.36. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 36 Specific symptoms, self‐rated at follow‐up.
2.37. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 37 Specific symptoms, clinician‐rated at follow‐up.
2.38. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 38 General symptoms, self‐rated at follow‐up.
2.39. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 39 Behavioural Test (level), clinician‐rated at follow‐up.
2.40. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 40 Behavioural Test (symptoms), self‐rated at follow‐up.
2.41. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 41 Response (specific), self‐rated at follow‐up.
2.42. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 42 Response (specific), clinician‐rated at follow‐up.
2.43. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 43 Recovery, clinician‐rated at follow‐up.
2.44. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 44 Depression, self‐rated at follow‐up.
2.45. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 45 Depression, clinician‐rated at follow‐up.
2.46. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 46 Depression improvement, self‐rated at follow‐up.
2.47. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 47 Disability, self‐rated at follow‐up.
2.48. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 48 Disability, clinician‐rated at follow‐up.
2.49. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 49 Quality of Life, self‐rated at follow‐up.
2.50. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 50 Anxiety (any measure), self‐rated at >6m.
2.51. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 51 Specific symptoms, self‐rated at >6m.
2.52. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 52 Specific symptoms, clinician‐rated at >6m.
2.53. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 53 General symptoms, self‐rated at >6m.
2.54. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 54 Behavioural Test (level), clinician‐rated at >6m.
2.55. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 55 Behavioural Test (symptoms), self‐rated at >6m.
2.56. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 56 Response (specific), self‐rated at >6m.
2.57. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 57 Response (specific), clinician‐rated at >6m.
2.58. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 58 Response (general), self‐rated at >6m.
2.59. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 59 Recovery, clinician‐rated at >6m.
2.60. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 60 Depression, self‐rated at >6m.
2.61. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 61 Depression improvement, self‐rated at >6m.
2.62. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 62 Disability, self‐rated at >6m.
2.63. Analysis.
Comparison 2 Media‐delivered interventions compared to face‐to‐face interventions, Outcome 63 Quality of Life, self‐rated at >6m.
Characteristics of studies
Characteristics of included studies [ordered by study ID]
Abramowitz 2009.
| Methods |
Location: Rochester (MN), USA Recruitment: Advertising and referral Exclusion rate: 25% Randomised (N): 21 (11 intervention; 10 comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); MINI (DSM‐IV) Duration (years): Unknown Age (years): 43.4 Sex (female): 76.19% Race (white): 57.14% Medication (using at baseline): 57.14% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Previous psychotherapy restricted Medication: "Individuals on psychotropic medication were instructed to remain on their current dose and were included as long as they had been at the same dosage for 3 months or more." Drug/Alcohol: "individuals were excluded if they reported substance abuse/dependence in last 6 months" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Shyness and Social Anxiety Workbook (Antony and Swinson, 2000) Days of treatment: 48 Author wrote: No Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face & Phone Automated contact: N=0 Provider contact: N=7 (180 min) Contact description: “At weeks 1, 2, 3, 6, and 8, a brief (<30 min) meeting with the therapist was held to review the chapters...No exposure or cognitive therapy took place; all CBT techniques were performed by the patient on his or her own. Questions for how to implement these techniques could be addressed...On weeks when no therapist contact was scheduled, a maximum 15‐min telephone call was scheduled." "Individuals who inquired about the study were screened by telephone. If they appeared to meet entry criteria, they were invited to undergo a diagnostic interview…" Intervention description: “Patients were provided with a copy of the SSAW free of charge. The 11 chapters in the workbook were divided into 5 sections to be read over the 8 weeks of therapy as shown in Table 1.” "CBT‐based self‐help resource that includes instruction in how to implement cognitive restructuring and situational exposure..." Compliance: "on the adherence question pertaining to completion of non‐exposure therapy assignments in the SSAW was 6.38 (SD=0.80; range 5–7), suggesting relatively good self‐reported adherence. On the question assessing adherence to exposure assignments, the mean score was 5.85 (SD= 1.32; range 2–7), also suggesting fairly good...." Adherence associated with better outcomes at follow‐up though not at post‐test. |
|
| Outcomes |
Specific Symptoms: Brief Social Phobia Scale; Clinical Global Impression (CGI): Severity; Social Interaction Anxiety Scale (SIAS) General Symptoms: State‐Trait Anxiety Inventory (STAI): Trait Depression: Beck Depression Inventory (BDI) |
|
| Notes |
Funding: Mayo Clinic and Mayo Foundation. Grant awarded to Elizabeth Moore. Unpublished data: Abramowitz provided details about the generation of the allocation sequence, recruitment methods, and duration of contact for assessment. Unable to provide further outcome data or data about participants. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “Participants were randomly assigned to 1 of 2 conditions" "We used a random number generator on a computer" (personal communication) |
| Allocation concealment (selection bias) | Low risk | “the allocation was not administered by a third party. The study coordinator simply generated the assignment on a computer.” (personal communication) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “...meeting with the therapist was held to review the chapters assigned for that particular week. The same therapist (ELM) worked with each patient and used a manual (available from the authors) to guide each meeting." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk |
Assessor‐rated outcomes: Yes Assessor blind: Yes “Two independent evaluators (IEs) administered all posttest and follow‐up assessments. IEs were trained in the administration of the BSPS and CGI‐S and completely blind to treatment condition and assessment time.” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: No Dropout There were 3 dropouts at follow‐up, but this occurred after the WL group received treatment and the results are not included in this review. |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Al‐Kubaisy 1992.
| Methods |
Location: London, England Recruitment: Referral Exclusion rate: 36.13% Randomised (N): 99 (34 intervention; 31 comparison) |
|
| Participants |
Disorder: Mixed (AG, SAD, SP); Clinical Interview (ICD‐10) Duration (years): 18 Age (years): 35 Sex (female): 65.66% Race (white): 11.25% Medication (using at baseline): 11.25% Education (years): 12.02 EXCLUSIONS Depression: Yes Psychotherapy: Previous psychotherapy restricted Medication: "If medication exceeds more than the daily equivalent of 5mg of diazepam, 100mg imipramine, or 10mg propranolol, taken only at night, for at least 4 months" Drug/Alcohol: "no more than 2 units of alcohol a day from at least 3 weeks before entering the trial" Physical: "no severe organic disease" |
|
| Interventions |
Comparison group(s): Applied relaxation (self‐help) Comparison description: "patients were asked to carry out 90 minutes daily of r while lying or sitting comfortably and listening to one or more of three half‐hour audiotapes of progressive muscle relaxation instructions (Jacobsen's) which were supplied....play the tapes of their choice intermittently to a total of 90 minutes daily and to record homework daily in a diary" Intervention name: Living With Fear (Marks, 1980) Days of treatment: 64 Author wrote: Yes Type of media: Book / Booklet Type of therapy: Exposure Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=6 (360 min) Contact description: "saw the clinician six times for an hour each time (at weeks 0, 1, 2, 3, 4, 6). In these six sessions the clinician helped the patient set relevant self‐guided homework (e or r) to be carried out over weeks 0‐8 for at least 90 minutes daily and be recorded in a daily diary. The clinician and patient reviewed problems and the homework diary together at each session except the first...Ee patients had a further 1.5 hours of clinician contact per session doing clinician‐accompanied live exposure (E) (6 × 1.5 hours =9 hours in all)." Intervention description: were asked to read the self‐help chapter from Living With Fear (Marks, 1980) and to follow its guidelines. From the avoidance profile worked out at initial assessment the patient and clinician together planned the (e) (self‐ exposure) program together. Patients were asked to complete 90 minutes of e daily to their most phobic stimuli that they could tolerate without escape (crowds, shops, zoo, etc.), and to record completed exposure homework tasks in a daily diary." Compliance: In the intervention group, participants reported 58 hours of homework out of 83 prescribed (72%). In the relaxation group, participants reported 62 of 84 hours (70%). Daily diary. Participants were not asked if they read the manual. Patient's compliance with homework was rated by the therapists based on a semi‐structured interview. |
|
| Outcomes |
Specific Symptoms: Fear Questionnaire (FQ) General Symptoms: Fear Questionnaire (FQ): Anxiety Depression Depression: Beck Depression Inventory (BDI); Hamilton Depression Rating Scale, clinician‐rated (HAM‐D) Disability: Work and Social Adjustment Scale (WSAS) |
|
| Notes |
Funding: Republic of Iraq grant awarded to TA‐K, ORS grant, University of London PhD. Unpublished data: Located thesis. Unable to contact first author. Two eligible intervention groups differed only in amount of contact. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk |
Method: Unclear “Randomization was stratified according to 3 phobic types‐agoraphobia, social phobia, or specific phobia" Dropouts were replaced (See Incomplete Outcome Data). |
| Allocation concealment (selection bias) | High risk | “At the end assessment the blind assessor made further assessment appointment for week 8, and handed the clinician a sealed envelope about the patient's treatment condition. Therapy then began (week 0) in the assigned treatment mode.” Dropouts were replaced (See Incomplete Outcome Data). |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Patients in all three conditions saw the clinician six times for an hour each time…" "The clinician helped the patient set relevant self‐guided homework..." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “...measures were self‐rated (S) and rated by an assessor (A)‐ psychiatrists, psychologists and nurse therapists‐kept blind to the treatment condition…” |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=12 (35.29%) Comparison: N=6 (19.35%) Method of analysis: Per protocol “The number of any patient who dropped out was returned to the pool of random numbers and reassigned to a fresh patient.” Int: 12/34 (4 treatment dropouts remained in the study, 4 refused, 4 dropouts). Con: 6/31 (2 refused, 4 dropouts). |
| Selective reporting (reporting bias) | Low risk | No trial registration number given, but data extracted from thesis likely complete. At 2‐year follow‐up "Only self‐rated measures were analysed because assessor‐rated measures were unavailable for patients who did not attend follow‐up and so could be biased." |
| Other bias | High risk | Dropouts were replaced (See Incomplete Outcome Data). |
Al‐Kubaisy 1992 (AG).
| Methods | As above. | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | |
| Incomplete outcome data (attrition bias) All outcomes | High risk | |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | Low risk | |
Al‐Kubaisy 1992 (SAD).
| Methods | As above. | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | |
| Incomplete outcome data (attrition bias) All outcomes | High risk | |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | Low risk | |
Al‐Kubaisy 1992 (SP).
| Methods | As above. | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | |
| Incomplete outcome data (attrition bias) All outcomes | High risk | |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | Low risk | |
Andersson 2009a.
| Methods |
Location: Stockholm, Sweden Recruitment: Advertising/ Internet Exclusion rate: 71.7% Randomised (N): 30 (15 intervention; 15 comparison) |
|
| Participants |
Disorder: Specific Phobia; SCID (DSM‐IV R) Duration (years): Unknown Age (years): 25.6 Sex (female): 84.8% Race (white): Unknown Medication (using at baseline): Unknown Education (years): 14.22 EXCLUSIONS Depression: Yes Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Individual Exposure Comparison description: “one‐session treatment was delivered in two sessions, with a first brief orientation session and then the 3‐hr exposure session, following Ost’s (1997) guidelines...cognitions are challenged during the exposures...and four jars with spiders of increasing size were prepared...participants were given the video after the completion of the exposure. They were also given a maintenance program and instructed to confront spiders...” Intervention name: Not named Days of treatment: 28 Author wrote: Yes Type of media: Internet Type of therapy: Exposure Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=4 (25min) Contact description: “Participants were contacted if they failed to send in homework assignment reports." "When the homework was reported the following week, the participant had to complete a brief set of questions in order to be allowed to proceed to the next module." "contact with the therapist was 25 min in total per client" Intervention description: “five text modules, which were presented on web pages and as downloadable PDF files...each participant had a therapist who was responsible for the whole treatment. E‐mails were used in the contact, and the whole process was password‐protected. In addition, a videotape illustrating exposure instruction was sent by post to the participants. Included psychoeducation, detailed exposure instructions, avoided situations and cognitions, exposure in real life, maintenance programme.” Compliance: “on average the participants’ own estimate of how much time they had devoted to the treatment was 2.4 hr. per week (total time: 12 hr.).” "participant had to complete a brief set of questions in order to be allowed to proceed to the next module" "participants were contacted if they failed to send in homework assignment reports" |
|
| Outcomes |
Specific Symptoms: Fear Survey Schedule General Symptoms: Beck Anxiety Inventory (BAI) Response: Behavioural Approach Test: Completed Depression: Beck Depression Inventory (BDI) |
|
| Notes | Funding: Swedish Research Council | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “randomised by an independent person” |
| Allocation concealment (selection bias) | Unclear risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “each participant had a therapist who was responsible for the whole treatment. E‐mails were used in the contact…” |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) Clinically significant improvement was derived from the BAT. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=2 (13.33%) Comparison: N=1 (6.67%) Method of analysis: Available Case because of computer problems (N=1) or lack of time (N=2). At follow‐up, "one participant dropped out from the Internet treatment condition and two from the live‐exposure treatment either because of lack of time or relocation." Percentages for the BAT indicate 7 missing. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. The stated primary outcome (BAT) is not reported in full. Mean scores for each group appear in a line graph with no error bars. |
| Other bias | Low risk | N/A |
Andersson 2012a.
| Methods |
Location: Stockholm, Sweden Recruitment: Advertising/ Internet Exclusion rate: 52.36% Randomised (N): 101 (50 intervention; 51 comparison) |
|
| Participants |
Disorder: OCD; SCID (DSM‐IV R) Duration (years): 18 Age (years): 34.01 Sex (female): 66.34% Race (white): 22.77% Medication (using at baseline): 22.77% Education (years): 13.89 EXCLUSIONS Depression: No Psychotherapy: Current and previous therapy restricted Medication: "Concurrent use of psychotropic medication was permitted, if it had been stable for at least 2 months prior to inclusion, and if the participant agreed to maintain a constant dosage throughout the study." Drug/Alcohol: "Current alcohol or drug abuse." Physical: "Physical illness that could interfere with ICBT." |
|
| Interventions |
Comparison group(s): Attention/Monitoring Comparison description: “…online non‐directive supportive therapy, which consisted of access to an e‐mail function integrated in the treatment platform…no active treatment components such as self‐help texts or worksheets. Each week, the therapist contacted the participant through the treatment platform to enquire how the week had progressed and to encourage the participant to discuss current distressing life events…” Intervention name: Not named (Andersson et al. 2011) Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email & Phone Automated contact: N=0 Provider contact: N=52 (129min) Contact description: “provide feedback on homework assignments, grant consecutive access to the modules, and to support the participants in doing ERP…support or clarification…if they had not logged on to the treatment platform for 7 days.” “for the ICBT group was 129 min (SD=67.26) and the total number of messages sent from the therapist was 35 (SD=13.95)" 17 min/16 messages control. "... 17 telephone calls to the ICBT group reminding them to report ERP progression on the treatment platform. For the control condition, the therapists made 41 telephone calls..." Intervention description: “text material (about 100 pages) and worksheets divided into 10 modules…accessible as an mp3 file (about 5 h of total listening)… read the same texts relating to general psychoeducation and rationale for the treatment, but tailored examples of obsessions and compulsions…Modules 1–4 consisted of psychoeducation, cognitive restructuring of meta‐cognitions, and of establishing an individual ERP hierarchy…Modules 5–10 focused on doing daily in vivo ERP...” Compliance: “The average number of completed modules in the ICBT group was 7.28…Six participants in the ICBT group were considered as non‐completers, as they did not begin ERP.” |
|
| Outcomes |
Specific Symptoms: Clinical Global Impression (CGI): Improvement Response: Yale‐Brown Obsessive‐Compulsive Scale (Y‐BOCS) Depression: Montgomery and Asberg Depression Rating Scale (MADRS) Disability: Global Assessment of Functioning Scale (GAF) |
|
| Notes | Funding: Swedish Research Council and the Swedish Society of Medicine. “support was provided through the regional agreement on medical training and clinical research (ALF) between Stockholm County Council and Karolinska Institutet.” | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “Participants were randomized (www.random.org) with a 1:1 ratio” |
| Allocation concealment (selection bias) | Low risk | “by an independent person who was not involved in the study.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “This group used the same therapists as the ICBT group but this contact did not include any CBT interventions.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “Blinding was broken for five participants in the ICBT group and for one participant in the control condition during the post‐treatment interview assessments.” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=2 (4%) Comparison: N=0 (0%) Method of analysis: Available Case “One participant in the ICBT group was lost to the post‐treatment telephone interview assessment, and two participants did not complete the internet self‐ rating questionnaires...There was no loss of data for the control group at baseline or post‐treatment.” |
| Selective reporting (reporting bias) | High risk |
Trial registration number: NCT01347099 Dimensional Obsessive Compulsive Scale and EuroQoL not reported. CGI and GAF were not registered. Dichotomous CGI results not reported. |
| Other bias | Low risk | N/A |
Andersson 2012b.
| Methods |
Location: Sweden Recruitment: Advertising/ Internet Exclusion rate: 44.1% Randomised (N): 204 (102 intervention; 102 comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); SCID (DSM‐IV) Duration (years): Unknown Age (years): 38.3 Sex (female): 60.20% Race (white): Unknown Medication (using at baseline): 13.73% Education (years): 12.96 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted; no previous restrictions reported Medication: "if on prescribed medication for anxiety/ depression, dosage had to be constant for 3 months before the treatment onset and kept constant throughout the study" Drug/Alcohol: "not admitting another serious or dominant disorder (e.g. psychosis, substance misuse) that could be expected to influence the outcome of the study" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐list Intervention name: Social Fobi‐Effektiv Hjalp med Kognitiv Beteendeterapi [Social Phobia ‐ Effective Help with CBT] Days of treatment: 56 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=9 Provider contact: N=9 (135 min) Contact description: “Feedback was given each week by the therapists. Text messages were used to remind participants to log in or to complete weekly reports on the LSAS‐SR.” “The treatment group had access to an Internet therapist during the 9 week treatment period. E‐mail correspondence occurred weekly (Sundays) and generally concerned the results of homework assignments as described in the self‐help manual.…On average, Internet therapists spent 15 min per week for each participant reading messages and providing feedback via the online contact handling system.” Intervention description: "186 pages divided into nine chapters (modules) adapted for use via the Word Wide Web…introductory module describing SAD and…CBT… a cognitive model for SAD…cognitive restructuring... exposure and attention shifting exercises…social skills and relapse prevention…complete one module every week...Each module consisted of information, exercises (home‐work assignments) and ended with a short quiz..." "both groups had access to separate moderated online discussion forums." Compliance: "46/102 (45%) failed to complete all nine modules...activity in the online discussion forums varied in line with previous investigations, which means that a majority made few comments and postings in addition to the postings linked to the ‘‘topic of the week’’, some were more active with discussions, and some mainly read were passive." |
|
| Outcomes |
Specific Symptoms: Liebowitz Social Anxiety Scale (LSAS); Social Phobia Scale (SPS); Social Interaction Anxiety Scale (SIAS); Social Phobia Screening Questionnaire (SPSQ) Response: Clinical Global Impression (CGI); Liebowitz Social Anxiety Scale (LSAS) Depression: Montgomery and Asberg Depression Rating Scale (MADRS) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes | Funding: Swedish Research Council | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online "Randomization was performed by an independent third‐party using an online true random‐number service (www.random.org)." |
| Allocation concealment (selection bias) | Low risk | See "Sequence Generation." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "Feedback was given each week by the therapists" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) "independent" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N= 8 (7.84%) Comparison: N= 2 (1.96%) Method of analysis: LOCF "the last previous LSAS‐SR score was used to replace missing data." |
| Selective reporting (reporting bias) | Low risk |
Trial registration number: UMIN000001383 All outcomes reported. |
| Other bias | Low risk | N/A |
Andersson 2012c.
| Methods |
Location: Sweden Recruitment: Advertising/ Internet Exclusion rate: 54.49% Randomised (N): 54 (27 intervention; 27 comparison) |
|
| Participants |
Disorder: GAD; SCID (DSM‐IV) Duration (years): 20.05 Age (years): 42 Sex (female): 75.93% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current restricted; no previous restrictions reported Medication: "(e) if taking prescribed medication for anxiety or depression, the duration had to be at least 12 weeks, and the participant had to be on a stable dosage for at least 6 weeks (and such participants were instructed not to change medication and/or dosage during the trial)" Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐list Intervention name: Not named (as in Paxling 2011) Days of treatment: 56 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Internet forum Automated contact: N=9 Provider contact: N=9 (90 min) Contact description: “Except for the weekly online treatment contact and diagnostic procedures, no other contact took place between the therapists and participants…5 therapists provided the treatment for this group. Two were licensed psychologists…3 were psychology students…four supervision sessions were given of approximately 90 min each. Feedback from the therapist was provided…In addition, occasional reminders were sent. The mean therapist time devoted to each client during the overall treatment period was 92 min (SD = 61).” Intervention description: "text‐based treatment modules delivered on a weekly basis for 8 weeks… Introduction to GAD and the treatment…applied relaxation…applied relaxation, and worry time…cognitive restructuring…applied relaxation, cognitive distancing, and problem solving…exposure…interpersonal problem solving…sleep management…Relapse prevention and maintenance of progress.” Compliance: "Mean 5.1 (SD=2.5) modules completed." |
|
| Outcomes |
Specific Symptoms: Generalized Anxiety Disorder Questionnaire–IV; Penn State Worry Questionnaire (PSQW); General Symptoms: Beck Anxiety Inventory (BAI); State‐Trait Anxiety Inventory (STAI) Response: Generalized Anxiety Disorder Questionnaire–IV; Penn State Worry Questionnaire (PSWQ) Depression: Beck Depression Inventory (BDI); Montgomery and Asberg Depression Rating Scale (MADRS) Quality of Life: Quality of Life Inventory (QOLI) Recovery: No longer met criteria for diagnosis Response: Generalized Anxiety Disorder Questionnaire–IV; Penn State Worry Questionnaire (PSQW); Clinical Global Impression (CGI) |
|
| Notes | Funding: Swedish Council for Working and Life Research | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online "unrestricted randomization" |
| Allocation concealment (selection bias) | Unclear risk | N/A |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "Feedback from the therapist was provided…" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) "participants were asked not to reveal whether they had received treatment." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N= 0 (0%) Comparison: N= 0 (0%) Method of analysis: mixed effects "Mixed effect models are able to accommodate missing data and integrate time‐varying factors." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Andrews 2011a.
| Methods |
Location: Sydney, Australia Recruitment: Referral Exclusion rate: 50.67% Randomised (N): 37 (23 intervention; 14 comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); Clinical Interview (DSM‐IV) Duration (years): Unknown Age (years): 31.9 Sex (female): 40.5% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: "Change in medications during last 1 month or intended change during study duration." Drug/Alcohol: "Current substance abuse/dependence" Physical: N/A |
|
| Interventions |
Comparison group(s): Individual CBT Comparison description: "Each group had a maximum of seven participants (not all of whom were research participants) who met weekly for seven weeks for 4 h under the guidance of the same clinician (M.D.). The content of the programme followed the programme outlined in a standard text. All participants were given a copy of the programme to use in the sessions and to revise between sessions." (Andrews G, Creamer M, Crino R, Hunt C, Lampe L, Page A (2003). The treatment of anxiety disorders.) Intervention name: Shyness Program (http://www.climateclinic.tv) Days of treatment: 56 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email & Phone Automated contact: N=11 Provider contact: N=7 (duration unknown) Contact description: “automatic emails and fortnightly short message service (SMS)...Participants were telephoned or emailed each week by the clinician.” Intervention description: “six online lessons; a summary/homework assignment for each lesson; comments by participants on a forum moderated by the clinician (M.D.)…provided education about the symptoms and treatment…how to develop an exposure hierarchy…cognitive restructuring…relapse prevention. Participants were encouraged to complete the first four lessons within the first two weeks, in order to provide more opportunity to practise the graded exposure, cognitive skills and other coping techniques.” Compliance: 6 withdrew before treatment began. 1 terminated at lesson 3, 1 at lesson 4, 1 at lesson 6. |
|
| Outcomes |
Specific Symptoms: Social Interaction Anxiety Scale (SIAS) Disability: WHO Disability Assessment Schedule (WHODAS‐II) |
|
| Notes |
Funding: None acknowledged Unpublished data: Personal correspondence. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “by NT via a true randomization process (www.random.org)” |
| Allocation concealment (selection bias) | Low risk | “by NT via a true randomization process (www.random.org)” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Participants were telephoned or emailed each week by the clinician.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=6 (26.09%) Comparison: N=0 (0%) Method of analysis: LOCF The pre‐treatment scores of the 10 participants who did not complete the post‐treatment questionnaires were replicated as their post‐treatment scores but only those who started lesson 1 were "eligible for analysis.” |
| Selective reporting (reporting bias) | High risk |
Trial registration number: ACTRN12609000212257 PHQ‐9, Kessler‐10 and Sheehan Disability Scale all stated in protocol and omitted from write‐up |
| Other bias | Low risk | N/A |
Baillie 2002.
| Methods |
Location: Sydney, Australia Recruitment: Advertising/ Internet Exclusion rate: 77.06% Randomised (N): 117 (51 intervention; 66 comparison) |
|
| Participants |
Disorder: Panic Attacks; CIDI (DSM‐IV) Duration (years): 8.13 Age (years): 37.93 Sex (female): 76.07% Race (white): 59.83% Medication (using at baseline): 59.83% Education (years): 13.38 EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Treatment‐as‐usual Intervention name: Booklet based on Rapee, Craske and Barlow (1996) and "Panic Surfing" Days of treatment: 137 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Phone Automated contact: N=0 Provider contact: N=1 (duration unknown) Contact description: People who did not complete assessments were reminded by post after two weeks, sent a second copy of the questionnaire after 4 weeks, and telephoned after 6 weeks. Intervention description: Stepped‐up care, moving up if panic attacks continued or MIA score 1.67 or greater. First: "posted a psychoeducational booklet." Second: a manual that "focuses on catastrophic misinterpretations of physical sensations...daily diary and described a five‐week program of activities to challenge catastrophic thought, carry out exposure to situations and sensations related to panic, and develop a plan of relapse prevention." Compliance: There was not evidence that treatment group, overall (est.=0.29, SE=0.27, Z=1.10) nor the self‐help manual specifically (est.=0.04, SE=0.31, Z=0.13) influencing the frequency that participants used exposure. |
|
| Outcomes | Recovery: Clinically Significant Improvement (Composite) | |
| Notes |
Funding: National Health and Medical Research Council Public Health Postgraduate Research Scholarship. Macquire University Postgraduate Research Fund. Division of Scientific Affairs of the Australian Psychological Society. Unpublished data: Baillie provided unpublished thesis and information about the trial design. Requiring written consent introduced a delay between assessment and posting the booklet of 18.5 (14.6) days. Data about duration of illness appear unreliable. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “A list of random assignments was constructed at the outset of the trial and participants were assigned in the order that their consent forms were received by post." (personal communication) |
| Allocation concealment (selection bias) | High risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “All telephone interviews were conducted by the first author…” |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) “Participants were not blind to their allocation and all telephone assessments [were] conducted by the first author who was not blind to group allocation." "At baseline and at 6 weeks, 4.5 months (20 weeks), and 9 months (40 weeks) participants completed a telephone interview and a self report questionnaire sent by post." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=2 (3.03%) Method of analysis: Available Case Of 468 assessment points (117 participants x 4 collections), there were 437 valid responses. For Panic Disorder Severity Scale, group means were substituted for missing cases. Further details are not reported by group. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Raw data are not reported and regressions based on 9 month outcomes cannot be incorporated in meta‐analysis. The authors interpret the data to indicate no effect. Missing measures include the Depression, Anxiety, Stress Scales (DASS), Mobility Inventory for Agoraphobia (MIA), and panic diary. |
| Other bias | Low risk | N/A |
Baker 1973.
| Methods |
Location: Cambridge (Mass), USA Recruitment: Advertising/ Internet Exclusion rate: Unknown Randomised (N): 30 (9 intervention; 9 comparison) |
|
| Participants |
Disorder: Specific Phobia; Unclear Duration (years): Unknown Age (years): 32 Sex (female): 70% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Individual Exposure Comparison description: “standard systematic desensitization with a therapist (cf. Wolpe and Lazarus, 1966)...Following one session for hierarchy construction, three or four sessions were used for relaxation training; S was also encouraged to practice relaxation at home...median of eight desensitization sessions (range 5‐10); each session included a median of 14 image presentations, each lasting about 30 set with 45 set rest between trials...continued until S completed his hierarchy.” Intervention name: Based on Behavior Therapy Techniques: A Guide to the Treatment of Neurosis (Wolpe, J & A. A Lazarus; 1996) Days of treatment: 49 Author wrote: Yes Type of media: Audio Type of therapy: Desensitization Location used: Clinic/ Surgery Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=6 (90 min) Contact description: “seen by this therapist for only one full session, to construct a hierarchy. Thereafter, S came to an office to conduct, on his own, a tape recorded relaxation or desensitization session...every second session S would speak with his therapist for about 5 min to discuss progress or problems.” Intervention description: “came to an office to conduct, on his own, a tape recorded relaxation or desensitization session, using a taped version of the self‐directed desensitization record…” "...three or four relaxation sessions were followed by median of 7 desensitization sessions (range 5‐14)." Compliance: The number of sessions intended was not reported. The totals reported are the sessions actually attended. |
|
| Outcomes | Specific Symptoms: Acrophobia Questionnaire: Anxiety | |
| Notes |
Funding: Foundations' Fund for Research Unpublished data: Provided information about assignment of participants. Unable to provide further information about the results. It is unclear how previous reviewers calculated effect sizes for this study. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk |
Method: Unclear “Wait‐list group excluded: 'Ss who would be unable to schedule sessions throughout the following 2 months (but were available later) were arbitrarily placed on the WL. All other Ss were blocked by sex and randomly assigned to one of three conditions..." WL group excluded as clearly not random (12 participants not included). |
| Allocation concealment (selection bias) | High risk | After the initial interview and the polygraph session, S was scheduled to begin treatment or was placed on the Waiting List. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk |
Provider contact: Yes Provider blind: No “assigned randomly to one of the authors, but was seen by this therapist for only one full session” |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) “this session was conducted by an E who was blind to S’s treatment condition. Since S’s treatment condition would become apparent to E during the interview, E first administered the objective tests, then gave S a self‐report questionnaire to complete, and then conducted the interview.” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=2 (22.22%) Method of analysis: Available Case 9 were assigned to face‐to‐face therapy. 1 transferred to the wait‐list and 1 dropped out after 3 relaxation and 2 desensitization sessions. After post‐treatment assessment, 3 WL participants were assigned to each treatment group and 6 undertook treatment at home and were not followed. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Summary statistics are not reported and statistical tests are reported selectively. Authors report that changes on the Leary and MMPI were not significant. Data insufficient to analyse Slide‐Series Discomfort Rating. |
| Other bias | High risk | May not be a RCT, and it is not indexed as such in electronic databases. |
Barrera 1977.
| Methods |
Location: Eugene (Oregon), USA Recruitment: Advertising/ Internet Exclusion rate: Unknown Randomised (N): 24 (16 intervention; 8 comparison) |
|
| Participants |
Disorder: Specific Phobia; Questionnaire & BAT Duration (years): 25.6 Age (years): 31.6 Sex (female): 100% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Attention/Monitoring Comparison description: “self‐administered placebo with self‐reward contracting” Intervention name: Rosen, G. M. (1974). A manual for self‐administering systematic desensitization in your home. University of Oregon. Days of treatment: 56 Author wrote: Yes Type of media: Book / Booklet Type of therapy: Desensitization Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: Unknown Contact description: The self‐reward contingency contracting supplement received by subjects in SSDCC and PCC was explained during an individual session that followed pretesting. Intervention description: 1) self‐administered desensitization 2) "self‐administered desensitization with self‐reward contracting" "adapted from Rosen et al. (1976)." Compliance: “While working on their programs, subjects had no contact with project staff, although they were to mail in weekly progress reports as previously described.” "As in earlier studies, 50% of SSD subjects (n = 4) finished treatment, whereas not one of the subjects in SSDCC progressed beyond the relaxation training phase of the program." |
|
| Outcomes |
Specific Symptoms: Liebowitz Social Anxiety Scale, self‐rated (LSAS‐SR) Response: Liebowitz Social Anxiety Scale, self‐rated (LSAS‐SR); Social Interaction Anxiety Scale (SIAS); Social Phobia Scale (SPS) Depression: Beck Depression Inventory (BDI) |
|
| Notes |
Funding: None acknowledged Unpublished data: Programme duration not reported ‐ assumed it was delivered as in Rosen 1976. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “Subjects were assigned on a random basis...” |
| Allocation concealment (selection bias) | Unclear risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “The self‐reward contingency contracting supplement received by subjects in SSDCC and PCC was explained during an individual session that followed pretesting.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes included. “Assessment instruments included a standard behavioral avoidance test, fear thermometer (FT) ratings, a snake attitude questionnaire, the snake item from Geer's Fear Survey Schedule (FSS), discomfort ratings while viewing snake and neutral slides, and a general fear‐change rating.” |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk |
Not analysed at post‐treatment Intervention: Unknown Comparison: Unknown Method of analysis: Unclear |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Outcome data cannot be analysed. "Assessments occurred at pre‐ assessment, postassessment, and 1‐month follow‐ up periods." "between‐groups differences on posttest or follow‐up scores were not revealed" |
| Other bias | Low risk | N/A |
Bell 2012.
| Methods |
Location: Christchurch, New Zealand Recruitment: Referral Exclusion rate: 92.73% Randomised (N): 83 (40 intervention; 43 comparison) |
|
| Participants |
Disorder: Mixed (GAD, PD, SAD); SCID (DSM‐IV) Duration (years): 18.01 Age (years): 35.31 Sex (female): 67.47% Race (white): Unknown Medication (using at baseline): 59.03 Education (years): 12 EXCLUSIONS Depression: No Psychotherapy: Current restricted; no previous restrictions reported Medication: "started on, or changed the dose of, an antidepressant in the previous 6 weeks." Drug/Alcohol: "current diagnosis of substance dependence" Physical: "significant or disabling cardiac, respiratory or neurological condition (which would make participation in the trial medically unwise)" |
|
| Interventions |
Comparison group(s): Wait‐list Intervention name: Based on Andrews et al. 2003 (The Treatment of Anxiety Disorders: Clinician Guides and Patient Manuals) Days of treatment: 89 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Phone Automated contact: N=0 Provider contact: N=6 (30 min) Contact description: "The research assistant telephoned participants in the CCBT condition every 2 weeks over the treatment phase of the study (i.e. the first 12 weeks)...the WLC group were also contacted by the research assistant every 2 weeks over the same timeframe. The content of the telephone call followed a predetermined structure for both groups and was of about 5 minutes’ duration. It involved checking if participants were having any technical problems with the programme and encouraged them to complete the sessions." Intervention description:“(GAD: four lessons; panic disorder: six lessons; social phobia: six lessons). Part of the content of each lesson was presented in the form of an illustrated story…provided education…gave instructions about developing an exposure hierarchy and practising graded exposure, demonstrated principles of cognitive restructuring and concluded with information about relapse prevention.” Compliance: "Of the 40 patients randomised to CCBT, 14 (35%) did not complete the treat‐ ment (as defined above) (GAD = 2/7, 29%; social phobia = 5/17, 29%; panic disorder = 7/16, 44%)...In order to allow comparison with other CCBT studies using the same programme in different settings and with different design, the absolute completion rates of the CCBT (i.e. all sessions completed) were 4/7 (57%) patients with GAD, 9/17 (53%) patients with social phobia, and 5/16 (31%) patients with panic disorder." |
|
| Outcomes |
Specific Symptoms: Global severity General Symptoms: Beck Anxiety Inventory (BAI); Fear of Negative Evaluation (FNE); Fear Questionnaire (FQ); Generalised Anxiety Disorder Assessment Inventory (GADI); Liebowitz Social Anxiety Scale (LSAS) Depression: Beck Depression Inventory (BDI) Disability: Work and Social Adjustment Scale |
|
| Notes | Funding: Canterbury District Health Board, Canterbury Medical Research Foundation, New Zealand Lottery Grants Board | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online "randomised to either CCBT or the WLC, using a strati‐ fied block design for the primary diagnosis (GAD, panic disorder or social phobia). The stratified randomisation list was generated by a statistician (CF) who was not involved in implementation of the study. " "Participants were randomised in a 1:1 ratio to the computerised programme and WLC." |
| Allocation concealment (selection bias) | Low risk | "The allocation list and envelopes containing the allocations were held by the CRU coordinator (who was not involved directly in implementa‐ tion of the study) to ensure that the clinicians and the research assistant involved in assessment and enrolment were not biased in the enrolment process" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "All participants in the trial (both those randomised to CCBT and those to WLC) were contacted by the research assistant at two‐weekly intervals across the treatment phase of the study (six times over the 12 weeks)." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N= 0 (0%) Comparison: N= 0 (0%) Method of analysis: mixed effects "All data analysis was carried out according to a pre‐established statistical analysis plan. Analyses of participants’ self‐rated questionnaire scores were undertaken using mixed model repeated measures (MMRM) controlling for baseline scores and testing for the between‐group factors of group (CCBT, WLC) and primary diagnosis (GAD, panic disorder, social phobia)." |
| Selective reporting (reporting bias) | Unclear risk | Trial registration is incomplete and does not list measures used: ACTRN12606000349549; URB/06/05/039 |
| Other bias | Low risk | N/A |
Berger 2009.
| Methods |
Location: Bern, Switzerland Recruitment: Advertising/ Internet Exclusion rate: 70.45% Randomised (N): 52 (31 intervention; 21 comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); SCID (DSM‐IV) Duration (years): 10.05 Age (years): 28.9 Sex (female): 55.8% Race (white): 1.92% Medication (using at baseline): 1.92% Education (years): 13.77 EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Based on CBT (Clark and Wells 1995; Stangier, Heidenreich and Peitz 2003). Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=10.9 (duration unknown) Contact description: “therapists have their own Internet‐based platform where they have an overview of all their patients and an easy and quick access to the Web‐based environment of each patient.” "therapists were instructed to write a short motivating message to the clients once a week" Author estimates 120 minutes for SCID (personal communication), and "The average number of emails written by the participants was 6.01....The average number of emails written by the therapists was 10.9..." Intervention description: “based on the established cognitive–behavioral approach by Clark and Wells (1995; Stangier, Heidenreich, & Peitz, 2003)...participants are able to freely navigate through the Web pages and repeat exercises...57 Web sites that are divided into five sessions.” "module for establishing regular text‐based contact with a therapist, a continuous monitoring and feedback system of patients’ responses, as well as collaborative online group elements" Compliance: 1 participant did not write to the therapist and completed only 15% of the guide, 2 completed 40% and 50% of the guide but not post‐treatment (no reason, lack of time). Those who completed post‐treatment completed 85% of the self‐help guide (16 completed 5 sessions, 6 completed 4 sessions, 5 completed 3 sessions, one completed only the first session). |
|
| Outcomes |
Specific Symptoms: Liebowitz Social Anxiety Scale, self‐rated (LSAS‐SR) Response: Liebowitz Social Anxiety Scale, self‐rated (LSAS‐SR); Social Interaction Anxiety Scale (SIAS); Social Phobia Scale (SPS) Depression: Beck Depression Inventory (BDI) |
|
| Notes |
Funding: Swiss National Science Foundation (SNF 100011‐112345) Unpublished data: Berger provided demographic details, contact with participants, and details about randomisation and allocation concealment. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “According to a computer‐generated randomization scheme, 31 of the 52 subjects included in the randomization were assigned to the treatment group and 21 to the control group.” |
| Allocation concealment (selection bias) | Unclear risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “When patients log into the program for the first time, they are redirected to the contact module, where a therapist has introduced her‐ or himself and informed the patients that they may contact her/him whenever they want to.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: LOCF “All statistical analyses used intent‐to‐treat principles in which pretreatment data were carried forward for noncompleters to replace missing values. However, there were few drop‐outs in our study, with 90% of the participants completing the questionnaires at postassessment.” |
| Selective reporting (reporting bias) | High risk |
Trial registration number: ISRCTN62304985 The trial registration lists the State‐Trait Anxiety Inventory (STAI), but this is not reported. |
| Other bias | Low risk | The registered age range was 18‐35 but the report includes participants 18‐45. |
Bergstrom 2010.
| Methods |
Location: Stockholm, Sweden Recruitment: Referral Exclusion rate: 71.46% Randomised (N): 113 (53 intervention; 60 comparison) |
|
| Participants |
Disorder: Panic disorder; MINI (DSM‐IV) Duration (years): 6.68 Age (years): 34.22 Sex (female): 61.4% Race (white): 45.04% Medication (using at baseline): 45.04% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "If taking prescribed drugs for panic disorder, having had a constant dosage for 2 months prior to commencing treatment in the study" Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Group CBT Comparison description: The group treatment was led by two clinical psychologists who presented the self‐help programme mentioned above during weekly 2‐hour sessions, with the support of printed handouts of the modules given to the patients. "the 54 group patients were distributed over 10 different groups whose sessions were 2 hours each and led by 2 therapists, and that the actual average number of weekly group sessions attended in the group treatment was 8.1 (SD = 2.1)" Intervention name: Not named Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=11.3 (35 min) Contact description: “Each module ended with a number of questions to be answered by the patient through interactive forms (e.g. homework assignments). After reviewing these answers, the psychologist gave access to the next module and provided feedback. At any moment the patient could post a message if he or she needed further help." "The total number of e‐mails sent by the therapists during treatment was 555 (mean per patient: 11.3, SD = 4.3). The total average therapist time spent per patient in the Internet treatment was 35.4 minutes (SD = 19.0)." Intervention description: “...psychoeducation (module 1), cognitive restructuring (modules 2 and 3), interoceptive exposure (modules 4 and 5), exposure in‐vivo (for agoraphobic situations; modules 6 to 9), and relapse prevention (module 10)...The patient also had the opportunity to participate in an online discussion forum with other patients in treatment during the same time period. However, this was not mandatory." Compliance: The average number of weekly modules completed in the Internet treatment was 6.7 (SD = 2.5). |
|
| Outcomes |
Specific Symptoms: Panic Disorder Severity Scale (PDSS) General Symptoms: Anxiety Sensitivity Index (ASI) Response: Clinical Global Impression (CGI): Improvement; Panic Disorder Severity Scale (PDSS) Recovery: No longer met criteria for diagnosis Depression: Montgomery and Asberg Depression Rating Scale (MADRS) Disability: Sheehan Disability Scale (SDS) |
|
| Notes |
Funding: Stockholm County Council Unpublished data: Table 3 appears to contain an error ‐ means and SEs are not reported for each group. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Unclear “The participants were divided into two groups, Internet or group treatment, by an independent random‐number procedure…” |
| Allocation concealment (selection bias) | Low risk | “...each patient was assigned to either treatment by the opening of sealed numbered envelopes.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Each module ended with a number of questions to be answered by the patient through interactive forms (e.g. homework assignments). After reviewing these answers, the psychologist gave access to the next module and provided feedback.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “The psychiatrists performing the clinical interviews at post‐treatment and follow‐up were blind to treatment condition.” |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=9 (16.98%) Comparison: N=11 (18.33%) Method of analysis: Available Case “Nine participants dropped out after randomisation but before commencing treatment. Various reasons were given for not starting treatment, but all pertained to different life circumstances of the individual participants and not to randomisation status. These initial dropouts were excluded from the statistical analyses.” "A number of patients did not return for the clinical interview...a Mixed effects models approach was used in the statistical analysis to adjust for these missing values." |
| Selective reporting (reporting bias) | Unclear risk |
Trial registration number: NCT00845260 The study was registered after it had been completed. All registered outcomes are reported, but the CGI is reported and not registered. |
| Other bias | Low risk | N/A |
Bickel 2007.
| Methods |
Location: Ohio, USA Recruitment: Advertising/ Internet Exclusion rate: 85.03% Randomised (N): 22 (11 intervention; 11 comparison) |
|
| Participants |
Disorder: Panic disorder; ADIS (DSM‐IV) Duration (years): Unknown Age (years): 42 Sex (female): 73.73% Race (white): 68.18% Medication (using at baseline): 68.18% Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: Current and previous therapy restricted Medication: "Patients who were currently taking medication for the treatment of panic disorder on a regular basis had to be willing to keep their dosage constant through the 6‐week evaluation period." No "Initiation or reinitiation of tricyclic antidepressants, SSRIs, or MAO inhibitors during the past 6 months." nor "Initiation or reinitiation of benzodiazepines in the past 30 days." Drug/Alcohol: N/A Physical: "Lifetime history of severe medical disorders that could complicate panic disorder including cardiovascular, respiratory or renal disorders, stroke, epilepsy or hypertension." |
|
| Interventions |
Comparison group(s): Wait‐List Comparison description: Participants in both groups completed twice‐weekly monitoring forms. Intervention name: CALM (Bickel) Days of treatment: 42 Author wrote: Yes Type of media: Computer Type of therapy: Exposure Location used: Clinic/ Surgery Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=10 (duration unknown) Contact description: “The treatment was administered twice weekly at scheduled appointments. At each appointment, a trained undergraduate administrator asked the participant to complete a symptom monitoring form for the intervening period between sessions. These forms were used to alert the experimenter to any drastic changes in symptoms." Intervention description: 10 sessions, twice weekly for 5 weeks. "includes video, audio, and text. Approximately two thirds of the treatment is comprised of audio accompanied by text. The rest of the treatment is video‐based with supplementary text. The computer program is moderately interactive. In addition to the above, participants respond to onscreen quiz questions during the psychoeducational portion of treatment. Correct responses are required for the patient to proceed..." Compliance: “The quality of homework completed was rated either 'fair' or 'good for all clients across sessions with little variability between or within groups. Compliance ratings were completed by K.W.B.” |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ) General Symptoms: Anxiety Sensitivity Index (ASI); Beck Anxiety Inventory (BAI) Depression: Beck Depression Inventory (BDI) |
|
| Notes |
Funding: Society for the Science of Clinical Psychology and the Coca Cola Foundation Unpublished data: Bickel provided dissertation but was unable to provide further details about the study. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear "Twenty‐two participants (see power analysis below) were matched on severity of panic and agoraphobic symptoms and randomly assigned to one of two treatment conditions: treatment via CALM or a delayed treatment control condition, in a matched‐ pairs design." "Participants who qualified for the treatment study after the Time 1 interview were matched with another participant and were randomly assigned to receive immediate treatment or wait 5‐weeks to begin a delayed treatment." |
| Allocation concealment (selection bias) | Low risk | "The initial assessment, as well as the post‐treatment assessment, included the administration of the Anxiety Disorders Interview Schedule for the DSM‐IV (ADIS‐IV), conducted by a trained administrator who was blind to treatment condition." "All substantive interactions with clients were conducted by trained research assistants (assessments) or advanced undergraduate students (subsequent appointments) in order to reduce interactions with the therapist from the computer intervention (KWB)." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “At each appointment, a trained undergraduate administrator asked the participant to complete a symptom monitoring form for the intervening period between sessions.” "By administering the treatment at regular appointments, we were able to monitor completion of the treatment." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes are reported, but the paper reports, "The initial assessment, as well as the post‐treatment assessment.. conducted by a trained administrator who was blind to treatment condition." "Time 2 assessment was conducted subsequently by a trained interviewer who was blind to treatment condition" |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=3 (27.27%) Comparison: N=6 (54.55%) Method of analysis: Available Case At the end of the study, there were only 5 complete matched‐pairs. "we proceeded under the assumption that attrition was different between the two groups... For this review, data were extracted for all completers. The author's main analyses include only complete matched‐pairs. The pattern of results was essentially the same, but the effects were smaller for the author's analysis. (Those remaining in the comparison group were the most distressed.) "at the time of recruitment, our clinic was in a transition phase and therapist‐administered treatment was not available. Subsequent to the initiation of the study, therapists became available..." |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Mobility Inventory for Agoraphobia (MI) and Fear Questionnaire (FQ) not reported, except as graphs. Safety Maneuver Questionnaire measured but not reported as authors found it problematic and in need of further study. Baseline values for the ACQ and the BSQ (Table 2) are either incorrect or transformed through a process that is not described. |
| Other bias | Low risk | N/A |
Botella 2009.
| Methods |
Location: Castelló, Spain Recruitment: Advertising and referral Exclusion rate: Unknown Randomised (N): 52 (30 intervention; 22 comparison) |
|
| Participants |
Disorder: Social Anxiety (Specific); ADIS (DSM‐IV) Duration (years): Unknown Age (years): 24.4 Sex (female): Unknown Race (white): Unknown Medication (using at baseline): Unknown Education (years): 13.85 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: N/A Drug/Alcohol: "Exclusion criteria were current alcohol or drug dependence" Physical: N/A |
|
| Interventions |
Comparison group(s): Individual CBT Comparison description: “The therapist followed exactly the same steps as ‘Talk to me’: education, cognitive therapy, and exposure. The main difference was that instead of being a computer‐ based self‐applied treatment delivered over the Internet, treatment was provided by an experienced therapist.” "two sessions every week until they finished the treatment, receiving face‐to‐face therapy for no longer than two months" Intervention name: Talk to Me Days of treatment: 61 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: “These participants could contact the psychologist by e‐mail or telephone when they had any doubt or problem.” Intervention description: “six scenarios which consist of real videotaped audiences...the system asks some questions to make sure that the patient has understood the content...rationale for cognitive restructuring, highlighting the role of negative thoughts...Each scenario offered by the program has several variables (e.g., number of people) in order to build an exposure hierarchy.” "if they had no Internet access they could self‐apply the program at the university." Compliance: N/A |
|
| Outcomes | None | |
| Notes | Funding: Ministerio de Educacion y Ciiencia, Spain, PROYECTOS CONSOLIDER‐C (SEJ2006‐14301/PSIC), by Programa de Acciones Integradas con Sudafrica (HS2006‐0001), and by Universitat Jaume I ‐ Fundacio Caixa Castello (P1 1A2005‐06) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “All participants who wanted to take part in the study were randomly allocated to one of the two experimental conditions.” |
| Allocation concealment (selection bias) | Unclear risk | N/A |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “These participants could contact the psychologist by e‐mail or telephone when they had any doubt or problem. Another group received face‐to‐face therapy.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: Unknown Comparison: Unknown Method of analysis: Unclear No information given on dropout at any stage of the trial, only that there were more participants in the self‐administered condition because it usually had a higher attrition rate. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Data could not be extracted. The paper reports only significant correlations. |
| Other bias | Unclear risk | Methods are poorly reported and the conduct of the study cannot be fully assessed. |
Botella 2010.
| Methods |
Location: Castelló, Spain Recruitment: Advertising and referral Exclusion rate: 27.84% Randomised (N): 127 (62 intervention; 29, 36 comparisons) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); ADIS (DSM‐IV) Duration (years): Unknown Age (years): 24.4 Sex (female): 79.22% Race (white): Unknown Medication (using at baseline): Unknown Education (years): 14.82 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: N/A Drug/Alcohol: "not be diagnosed for substance abuse or dependence" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List, Individual CBT Comparison description: For two months, "Participants in the live therapy condition received therapy once or twice a week, depending on their availability. Treatment included individual sessions lasting 45 to 60 minutes. This treatment featured the same components as Talk to Me: education, cognitive therapy, and exposure." "wait‐list control group were assessed when they asked for help and 1 month afterwards when they had the chance to be treated" Intervention name: Talk to Me Days of treatment: 61 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: “Participants in the self‐ administered condition did not have any contact with the psychologist during the treatment, although they could e‐mail or telephone her if they had any problem with the system.” Intervention description: “information about the nature and physiological characteristics of anxiety, fear, and phobias. The cognitive restructuring component teaches users to identify and challenge negative thoughts…the program organizes a hierarchy of public speaking scenarios that were created during the initial assessment…When their level of fear has diminished 2 or more points, Talk to Me presents them with a new situation.” Compliance: N/A |
|
| Outcomes |
Specific Symptoms: Brief Fear of Negative Evaluation (BFNE) Behaviour Test (Level): Impromptu Speech Task: Performance Behaviour Test (Symptoms): Impromptu Speech Task: Anxiety; Impromptu Speech Task: Anxiety, assessor rated Recovery: No longer met criteria for diagnosis Depression: Beck Depression Inventory (BDI) Disability: Maladjustment Scale (MS) |
|
| Notes | Funding: Ministerio de Educacion y Ciiencia, Spain, PROYECTOS CONSOLIDER‐C (SEJ2006‐14301/PSIC), by Programa de Acciones Integradas con Sudafrica (HS2006‐0001), and by Universitat Jaume I ‐ Fundacio Caixa Castello (P1 1A2005‐06) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “One hundred twenty‐seven participants were randomly assigned to one of the following experimental conditions” |
| Allocation concealment (selection bias) | Unclear risk | N/A |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) Participants in the self‐ administered condition did not have any contact with the psychologist during the treatment, although they could e‐mail or telephone her if they had any problem with the system. Another group received face‐to‐face therapy. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Included assessor‐rated outcomes (blinding unclear) The participant reports his or her level of fear during the task, and the therapist also assesses it on a scale of 0, no fear at all, to 10, severe fear). "The therapist assesses the global severity of the participant on a 6‐point scale…" |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison (wait‐list): N=0 (0%) Comparison (individual CBT): N=0 (0%) Method of analysis: LOCF “We have postbaseline data of 35 of the 50 dropouts...We used the last rating as a postbaseline for those participants...In the 15 cases where the postbaseline data were unavailable because they dropped out right after randomization, baseline data were carried forward...” "...obligations like university exams and having not enough time to dedicate to the treatment. Some participants also dropped out because they had doubts about the efficacy of the program, and some because they felt better after a few sessions." Global Impression may be an Available Case analysis. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Dichotomous data not reported for the control group. Data for the "Maladjustment Scale (MS): Work" and "Maladjustment Scale (MS): Social" appear to be incorrect ‐ the values are identical. |
| Other bias | Unclear risk | Methods are poorly reported and the conduct of the study cannot be fully assessed. |
Bowler 2012.
| Methods |
Location: East Anglia, England Recruitment: Advertising/ Internet Exclusion rate: Unknown Randomised (N): 71 (24 intervention; 22 comparison; 25 other) |
|
| Participants |
Disorder: Social Anxiety (unspecified); Questionnaire only Duration (years): Unknown Age (years): 21.91 Sex (female): 64.29% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: Current or previous restricted Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐list Intervention name: E‐couch Days of treatment: 14 Author wrote: No Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=4 Contact description: "A researcher ensured participant attendance and general compliance with the module." Intervention description: “…accessed the e‐couch social anxiety program online over four sessions in the laboratory. A researcher ensured participant attendance and general compliance with the module…psychoeducational subsection, which contained information on the nature of social anxiety…’exposure practice,’ ‘modifying your thinking,’ ‘attention practice,’ and ‘social skills training.’…During the course, participants completed two pieces of homework concerning exposure practice and social skills practice, respectively.” Compliance: "A researcher ensured participant attendance and general compliance with the module." |
|
| Outcomes |
Specific Symptoms: Fear of Negative Evaluation (FNE); Social Phobia Inventory (SPIN) General Symptoms: State Trait Anxiety Intentory (STAI) ‐ Trait Depression: Beck Depression Inventory (BDI) |
|
| Notes | Funding: Wellcome Trust Grant 083475 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomization was subject to the restriction that group sizes were approximately equal." |
| Allocation concealment (selection bias) | Unclear risk | "Randomization was subject to the restriction that group sizes were approximately equal." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "A researcher ensured participant attendance and general compliance with the module." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N= 3 (12.5%) Comparison: N= 2 (9.1%) Method of analysis: Per protocol "A complete‐case analysis approach, where only participants with all data points complete are included, was the primary approach used to analyze the data due to the small number of cases who dropped out (see Figure 1) and because it was reasonable to assume that the data were missing at random (Little & Rubin, 1987). In addition, for the symptom outcomes we also report intent‐to‐treat (ITT) analyses, and the pattern of results was unaltered." "Two participants (one in the cCBT group and one in the control group) were excluded from the analysis because they did not follow instructions correctly." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Bowman 1997.
| Methods |
Location: Birmingham, AL, USA Recruitment: Advertising/ Internet Exclusion rate: 38.71% Randomised (N): 38 (19 intervention; 19 comparison) |
|
| Participants |
Disorder: Generalised Anxiety Disorder; ADIS (DSM‐III R) Duration (years): Unknown Age (years): 42.91 Sex (female): 73.68% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: "not receiving pharmacotherapy unless stabilized on medication that one had taken for at least 2 months" Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Self‐Examination Therapy Days of treatment: 28 Author wrote: Yes Type of media: Book / Booklet Type of therapy: SET Location used: Anywhere Type of contact: Phone Automated contact: N=0 Provider contact: N=4 (20min) Contact description: “Daniel Bowman called participants once each week to make sure that no one needed to be referred to a mental health professional for evidencing psychosis, suicidal risk, homicidal risk, or mania…During the calls, he also offered to clarify any questions about SET, but no therapy was provided. Calls were restricted to approximately 5 min.” Intervention description: “The booklet contained 28 identical worksheets. We encouraged participants to use a worksheet each day. On the worksheets, participants recorded what mattered to them. They also recorded any problems they were having. Then they compared what was bothering them with what mattered. If what was bothering them did not relate to what mattered, they crossed it out and left the problem alone...” Compliance: “To be included in this study, participants receiving SET were required to complete at least seven worksheets in the SET booklet. All participants who received SET reported meeting the inclusion criterion.” "Before treatment, participants averaged answering 2.54 out of 7...After completing treatment, participants averaged answering 5.16 out of 7 questions correctly..." |
|
| Outcomes |
General Symptoms: Hamilton Anxiety Rating Scale, clinician‐rated (HAM‐A) |
|
| Notes |
Funding: None acknowledged Unpublished data: Authors confirmed that an equal number of participants were assigned to each group. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “randomly assigned to either the SET or the delayed‐treatment group.” |
| Allocation concealment (selection bias) | Unclear risk | "Immediately after the screening, one of three trained clinicians used the HARS‐R to assess participants who met the inclusion criteria. The clinicians were unaware of the treatment condition to which each participant was assigned. After the HARS‐R interview, participants completed the SCL‐90‐R, STAI, and SET quiz and were randomly assigned..." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Daniel Bowman called participants once each week" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “Each participant spent 4 weeks in a treatment condition and then was reassessed on the HARS‐R by a clinician who was unaware of the participant's treatment condition.” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=2 (10.53%) Comparison: N=1 (5.26%) Method of analysis: Available Case “Two participants from the SET group and 1 from the delayed‐treatment group did not return for the second assessment. One participant moved, 1 did not return our calls, and 1 was excluded from the study because she decided to start psychotherapy.” |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Carlbring 2001.
| Methods |
Location: Uppsala, Sweden Recruitment: Advertising/ Internet Exclusion rate: 91.8% Randomised (N): 41 (21 intervention; 20 comparison) |
|
| Participants |
Disorder: Panic disorder; ADIS (DSM‐IV) Duration (years): Unknown Age (years): 34 Sex (female): 70.73% Race (white): 64% Medication (using at baseline): 64% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "if on prescribed drugs for panic disorder, (a) the dosage had to be constant for 3 months before the start of the treatment, and (b) the patient had to agree to keep the dosage constant throughout the study" Drug/Alcohol: N/A Physical: "no epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic high blood pressure." |
|
| Interventions |
Comparison group(s): Wait‐List Comparison description: Study homepage included general information abut CBT. Intervention name: An End to Panic: Breakthrough Techniques for Overcoming Panic Disorder (Zuercher‐White, 1998). 20% was Mastery of Your Anxiety and Panic II (Barlow and Craske, 1994), Overcoming Panic: A Complete Nine‐Week Home‐based Treatment Program for Panic Disorder Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=7.5 (90min) Contact description: “The mean total time spent on each participant was approximately 90 minutes, including assessment, administration, and responding to the e‐mails. The number of reciprocal contacts (receive and send) ranged from 6 to 15 (M = 7.5, SD = 1.2)." "Each module ended with five to eight questions...Individual feedback was given within 24 hours...an assessment was made to judge whether the participant was ready to continue; if so, the password to the next module was sent." Intervention description: .”..six modules...psychoeducation...Clark's cognitive model (Clark, 1986)...breathing retraining...reveal catastrophic interpretations of physical symptoms and then to produce alternative interpretations... interoceptive exposure... exposure in vivo... assertiveness skills and how to deal with setbacks.” Compliance: All participants, except the dropouts, managed to complete all modules. Extensions permitted for business trips and illness. |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ) General Symptoms: Beck Anxiety Inventory (BAI) Depression: Beck Depression Inventory (BDI); Montgomery and Asberg Depression Rating Scale (MADRS) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes |
Funding: Swedish Foundation for Health Care Sciences and Allergy Research, the Boëthius Foundation, the Swedish Council for Research in the Humanities and Social Sciences, and the Swedish Medical Council Unpublished data: Carlbring provided details about randomisation, demographic measures, and number assigned to each group. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Mechanical “Participants were divided into two groups by the drawing of lots. These were drawn for the two treatment groupings pairwise for participants who had completed their baseline measurements. In other words, as soon as two participants had completed their baseline measurements, one was allocated to the treatment group and the other to the waiting‐list group.” |
| Allocation concealment (selection bias) | Low risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Individual feedback was given within 24 hours... an assessment was made to judge whether the participant was ready to continue” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: LOCF “In the treatment group, lack of time was given as the main reason for discontinuing (n = 3). One patient dropped out because of a newly discovered cancer. The person who left the waiting‐list group gave no reason. "In the statistical analysis, preassessment data for applicants who were allocated to one of the two study groupings but who did not complete the treatment were brought forward and used as postassessment data. This was done on the basis of an intention‐to‐treat evaluation of the results, which is a more conservative approach compared to only including completers of treatment." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Carlbring 2003.
| Methods |
Location: Uppsala, Sweden Recruitment: Advertising/ Internet Exclusion rate: 63.33% Randomised (N): 22 (11 intervention; 11 comparison) |
|
| Participants |
Disorder: Panic disorder; SCID (DSM‐IV) Duration (years): 10.4 Age (years): 37.95 Sex (female): 68.18% Race (white): 99.9% Medication (using at baseline): 99.9% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "if on prescribed drugs for PD, (a) the dosage had to be constant for 3 months before the start of the treatment, and (b) the patient had to agree to keep the dosage constant throughout the study" Drug/Alcohol: N/A Physical: "no epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic high blood pressure." |
|
| Interventions |
Comparison group(s): Applied relaxation (self‐help) Comparison description: In the AR group Ost’s applied relaxation book( Ost, 1997) was adapted for self‐help use via the WWW. A compact disc (CD) with three relaxation instructions was also sent to the participants. The treatment was divided into 9 modules: (1) psychoeducation, (2) rational, (3) progressive muscle relaxation: long version, (4) progressive muscle relaxation: short version, (5) conditioned relaxation, (6) differential relaxation, (7) quick relaxation, (8) applied relaxation, and (9) relapse prevention. Intervention name: An End to Panic: Breakthrough Techniques for Overcoming Panic Disorder (Zuercher‐White, 1998). 20% was Mastery of Your Anxiety and Panic II (Barlow and Craske, 1994), Overcoming Panic: A Complete Nine‐Week Home‐based Treatment Program for Panic Disorder Days of treatment: 183 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email & SMS Automated contact: N=0 Provider contact: N=7 (30min) Contact description: An e‐mail message to inquire how work with the current module was progressing was sent out once... "Participants had to answer the questions at the end of each module before they received the password to the next module. The mean total time spent by the therapist on each participant was approximately 30 min, including administration, and responding to the e‐mails. Most answers were fully standardized. Often only the participants name was altered in the greeting phrase of the e‐mails." Intervention description: The main treatment component in the CBT group was a self‐help manual that was adapted for use via the WWW, and to be suitable for Swedish conditions. It consisted of 197 pages of text and exercises divided into 6 modules: psychoeducation, breathing retraining, cognitive restructuring, interoceptive exposure, exposure in vivo, relapse prevention and assertiveness training (for details see Carlbring et al., 2001). Compliance: The intervention group completed 56.1% (17.1) of modules, the control group completed 56.6% (30.0). |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ) General Symptoms: Beck Anxiety Inventory (BAI) Response: Panic Free Depression: Beck Depression Inventory (BDI) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes |
Funding: Swedish Foundation for Health Care Sciences and Allergy Research, the Boëthius Foundation, the Swedish Council for Research in the Humanities and Social Sciences, and the Söderström‐Köniska Foundation Unpublished data: Carlbring provided details about randomisation and demographic measures. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online Participants were divided into two groups by a true random number service (http://www.random.org). |
| Allocation concealment (selection bias) | Low risk | We thank Per Forslin and Carola Strandlund for the SCI interviews. "When it had been decided on what people to include all participants were randomized by a third party" (personal communication). |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) Standardized feedback was given within 7 days of the participants sending their answers via e‐mail. On the basis of these e‐mails, an assessment was made of whether the participant was ready to continue, if so, the password to the next module was sent. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: LOCF After randomization, five people dropped out during the course of the study. There were three dropouts from the CBT group and two from the AR group. Lack of time was given as the main reason for discontinuing. In the statistical analysis, preassessment data for applicants who were allocated to one of the two study groupings but who did not complete the treatment were brought forward and used as postassessment data (n=5). |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Carlbring 2005.
| Methods |
Location: Uppsala, Sweden Recruitment: Advertising/ Internet Exclusion rate: 88.52% Randomised (N): 49 (25 intervention; 24 comparison) |
|
| Participants |
Disorder: Panic disorder; SCID (DSM‐IV) Duration (years): 9 Age (years): 34.98 Sex (female): 71.43% Race (white): 51% Medication (using at baseline): 51% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "if on prescribed drugs for PD: (a) the dosage had to be constant for 3 months before the start of the treatment and (b) the patient had to agree to keep the dosage constant throughout the study" Drug/Alcohol: N/A Physical: "to rule out general medical conditions the participant must have had a previous contact with a physician, psychologist, or other health professional as a consequence of panic attacks; no epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, or heart disorders." |
|
| Interventions |
Comparison group(s): Individual CBT Comparison description: Participants in the live therapy condition received 10 weekly individual sessions lasting 45–60 min. Between each session the participant was expected to do homework, which included reading a module handout identical to the text in the IT condition. Furthermore, each session was tape recorded and the participant was instructed to listen to it after the sessions to consolidate learning (Clark,1989). Intervention name: (Similar to Carlbring 2001.) Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=15.4 (150min) Contact description: “All contact was exclusively via e‐mail. The participants were encouraged to come up with questions or reflections during treatment, and they were free to send an unlimited number of e‐ mails. The total number of reciprocal contacts (receive and send) ranged from 4 to 31 (M=15:4; SD=5.5). As the e‐mail response to the participants often were very similar much text could be recycled. The mean total time spent on each participant was approximately 150 min, including administration, and responding to the e‐mails." Intervention description: The treatment was manualized and divided into 10 modules: (1–2) psychoeducation and socialization, (3) breathing retraining and hyperventilation test, (4–5) cognitive restructuring, (6–7) interoceptive exposure, (8–9) exposure in vivo, and finally (10) relapse prevention and assertiveness training. Each module consisted of approximately 25 pages, and was in large part similar to the previously tested self‐help material by Carlbring et al. (2001). Compliance: The intervention and control groups completed 7.4 (2.2) and 9.0 (2.7) modules (See Table 1). 28% intervention group finished all modules; 88% of comparison completed all sessions. Sessions completed did not correlate to change on any measure. "each module ended with an interactive multiple‐choice quiz that the participants needed to get 100% correct in order to proceed" |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ) General Symptoms: Beck Anxiety Inventory (BAI) Response: Agoraphobic Cognitions Questionnaire (ACQ); Body Sensations Questionnaire (BSQ); Mobility Inventory for Agoraphobia (MIA) Recovery: No longer met criteria for diagnosis Depression: Beck Depression Inventory (BDI); Montgomery and Asberg Depression Rating Scale (MADRS) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes |
Funding: Swedish Foundation for Health Care Sciences and Allergy Research, the Boëthius Foundation, the Swedish Council for Research in the Humanities and Social Sciences, and the Soderstrom Konigska Foundation. Unpublished data: Carlbring provided details about randomisation and demographic measures. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online "Participants were divided into two groups, live therapy (LIVE) or Internet‐based (IT) by a true random‐number‐service (http://www.random.org)." |
| Allocation concealment (selection bias) | Low risk | We thank Anders Wiberg for conducting nine SCID‐interviews and Katharina Johansson for the CBT‐supervision. "When it had been decided on what people to include all participants were randomized by a third party" (personal communication). |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "On the basis of these e‐mails, a subjective assessment was made by the therapist of whether the participant was ready to continue…" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) "To determine the clinical significance of the treatment a clinical reinterview (SCID) was administered by an independent psychologist blind for treatment condition. This was done 1 month after the treatment ended, and at a 1‐year follow‐up. To ensure the reliability of the diagnosis made, 10% of the tapes was randomly selected and reassessed by an independent psychiatrist with extensive SCID training." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: LOCF "Lack of time was given as the main reason for discontinuing. However, in accordance with the intention to treat paradigm (e.g., Nich & Carroll, 2002; Newell, 1992) post‐treatment data were collected from all dropouts. Six participants did not return their follow‐up questionnaires, and their post‐treatment scores were carried forward to the follow‐up assessment point. Hence, all 49 participants that were randomized to one of the two conditions are included in the statistical analysis." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Carlbring 2006a.
| Methods |
Location: Uppsala, Sweden Recruitment: Advertising/ Internet Exclusion rate: 83.24% Randomised (N): 60 (30 intervention; 30 comparison) |
|
| Participants |
Disorder: Panic disorder; SCID (DSM‐IV) Duration (years): Unknown Age (years): 36.7 Sex (female): 60% Race (white): 54% Medication (using at baseline): 54% Education (years): 13.09 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "If the participant was taking prescribed drugs for panic disorder, a) the dosage had to be constant for 3 months before starting treatment, and b) the participant had to agree to keep the dosage constant throughout the study" Drug/Alcohol: N/A Physical: "To rule out general medical conditions, the participant must have consulted a physician, psychologist, or other health professional" |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Similar to Carlbring 2001. Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email & Phone Automated contact: N=0 Provider contact: N=23.5 (238min) Contact description: “The total number of reciprocal contacts (received and sent) ranged from seven to 29 (mean=13.5, SD=4.4)...The mean time spent on each participant per week was approximately 12 minutes, including administration and responding to e‐mail. Weekly telephone calls were...timed and lasted an average of 11.8 minutes per week (range=9.6–15.6).” "In addition to the written material, all participants received one telephone call per week by the same therapist, each lasting, on average, 17.8 min (SD=4.2). The median total telephone time was 188 min." Data about contact from 2006 and 2011 paper are contradictory. Intervention description: received either the full book at the start of the treatment or one module per week during the 10 weeks "modules 1–2, psychoeducation and socialization; module 3, breathing retraining and hyperventilation test; modules 4–5, cognitive restructuring; modules 6–7, interoceptive exposure; modules 8–9, exposure in vivo; and finally, module 10, relapse prevention and assertive‐ ness training. Each module consisted of approximately 25 pages of written text...converted into interactive web pages..." Compliance: “The questions were included to promote learning and to enable the research supervisors to assess whether the participants had understood the material and completed their homework.” "Of 30 participants, 24 (80%) finished all of the modules within the intended 10‐week time limit. Hence, the average number of modules completed in this study was nine (mean=8.9, SD=2.6)." |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ) General Symptoms: Beck Anxiety Inventory (BAI) Recovery: No longer met criteria for diagnosis Depression: Beck Depression Inventory (BDI); Montgomery and Asberg Depression Rating Scale (MADRS) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes |
Funding: Swedish Foundation for Health Care Sciences and Allergy Research, the Boëthius Foundation, Swedish Research Council and the Soderstrom Konigska Foundation Unpublished data: Carlbring provided details about randomisation and demographic measures. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “The participants were divided into two groups, treatment or a waiting list, by a true random‐number service.” (www.random.org) |
| Allocation concealment (selection bias) | Low risk | “The authors thank Tommy Maurin and Josefin Nilsson for conducting the blind clinical telephone interviews.” "When it had been decided on what people to include all participants were randomized by a third party" (personal communication). |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Weekly telephone calls were made by the therapists to each participant. The purpose was to provide positive feedback and answer questions about the modules.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “The clinical significance of the treatment was assessed in two ways: one with a statistical method, the other with clinical judgment in a reinterview administered by an independent psychologist who was blind to treatment condition.” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: LOCF “posttreatment data were also collected from the participant who dropped out. Two participants in the treatment condition and one on the waiting list did not return their posttreatment questionnaires. Therefore, their pretreatment scores were carried forward to the posttreatment assessment point. Hence, all 60 participants who were randomly assigned to one of the two conditions were included in the statistical analysis.” |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. Anxiety diary reported in other papers but does not appear here. |
| Other bias | Unclear risk | N/A |
Carlbring 2007.
| Methods |
Location: Uppsala, Sweden Recruitment: Advertising/ Internet Exclusion rate: 75.31% Randomised (N): 60 (30 intervention; 30 comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); SCID (DSM‐IV R) Duration (years): Unknown Age (years): 32.65 Sex (female): 61.67% Race (white): Unknown Medication (using at baseline): Unknown Education (years): 13.75 EXCLUSIONS Depression: Yes Psychotherapy: Current and previous therapy restricted Medication: "if taking prescribed drugs for anxiety or depression, the dosage had to be constant for 3 months before the start of the treatment, and the participants had to agree to keep the dosage constant throughout the study" Drug/Alcohol: "... or substance misuse." Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Social Phobia‐Effective Treatment with Cognitive‐Behavioural Therapy (Furmark et al. 2006) Days of treatment: 63 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email & Phone Automated contact: N=0 Provider contact: N=19 (198min) Contact description: One weekly telephone call was made by the therapists to each participant in the treatment group. "Feedback on homework assignments was usually given within 24h after participants had sent their answers by email." "The mean total time per week spent on each participant was approximately 22 min, including telephone calls, administration, and reading and responding to emails. Hence, the total human contact time per participant including screening was over 2.5 h." Intervention description: “based on established cognitive–behavioural methods as described in self‐help books (e.g. Rapee, 1998; Antony & Swinson, 2000). The text, consisting of 186 pages, was taken from an existing manual (Furmark et al, 2006), divided into nine modules...included information, exercises and an interactive quiz, and ended with three to eight essay questions. Participants were asked to explain in their own words the most important sections of the module they had just completed, provide thought records...” Compliance: “The questions were intended to promote learning and to enable the online therapists to assess whether the participants had assimilated the material. For each module participants were required to post at least one message in an online discussion group about a predetermined topic.” "A total of 27 of the 29 people in the treatment group completed all nine modules within the intended 9‐week time frame. Lack of time was provided as the explanation for terminating treatment prematurely." |
|
| Outcomes |
Specific Symptoms: Liebowitz Social Anxiety Scale, self‐rated (LSAS‐SR): Avoidance General Symptoms: Beck Anxiety Inventory (BAI) Depression: Montgomery and Asberg Depression Rating Scale (MADRS) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes |
Funding: Swedish Research Council and the Soderstrom Konigska Foundation Unpublished data: Carlbring provided details about randomisation, demographic measures, recruitment, and contact with participants. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “divided into two groups (treatment or waiting‐list control) by an online true random‐number service…” |
| Allocation concealment (selection bias) | Low risk | "independent of the investigators and therapists. This service is run by the Department of Computer Science at the University of Dublin..." "When it had been decided on what people to include all participants were randomized by a third party" (personal communication). |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “One weekly telephone call was made by the therapists to each participant in the treatment group. The purpose was to provide positive feedback and to answer any questions the participant might have regarding the modules.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=2 (6.67%) Comparison: N=2 (6.67%) Method of analysis: Available Case “Prior to completing baseline measures, one control participant was excluded for lack of access to a computer. One participant in each condition was excluded because they started another treatment, and they do not appear in the analyses. One treatment‐completer did not provide post‐treatment measures.” "A total of 27 of the 29 people in the treatment group completed all nine modules within the intended 9‐week time frame. Lack of time was provided as the explanation for terminating treatment prematurely. One of them did not send in post‐treatment measures, which explains why intention‐to‐treat analysis was used." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Unclear risk | N/A |
Carlbring 2011.
| Methods |
Location: Umeå, Sweden Recruitment: Advertising/ Internet Exclusion rate: 60.58% Randomised (N): 54 (27 intervention; 27 comparison) |
|
| Participants |
Disorder: Mixed (any anxiety disorder); SCID (DSM‐IV) Duration (years): Unknown Age (years): 38.8 Sex (female): 75.93% Race (white): 25.93% Medication (using at baseline): 25.93% Education (years): 13.43 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: " taking no current medication for psycho‐logical problems or, if on medication, have an unchanged dosage during the last three months." Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Attention/Monitoring Comparison description: “invited to join a new confidential online support group specifically targeting anxiety problems. Each participant was asked to make at least one posting a week about a predetermined topic...presented by a therapist every eighth day, and participants were encouraged to comment on one another’s postings. The mean number of postings per participant, per topic were M=1.23 (SD=0.42) and total therapist time for writing and monitoring the online discussion area was approximately 1 h a week.” Intervention name: Not named Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=10 (150min) Contact description: “Eight clinical psychology M.Sc. students...responsible for 7‐10 participants...All contact with the participants, once they had been interviewed and included in the study, was via e‐mail. "If the therapist had not heard from the participant after a week, a reminder was sent by e‐mail." "Individual feedback was usually given within 24 h...an assessment was made to judge whether the participant was ready to continue...total time per week spent on each participant in this study was approximately 15 min, including administration as well as reading and responding to e‐mails." Intervention description: “combination of previous Internet‐based programs...All of these were, in turn, based on established CBT methods. From a total of 16 different modules, each participant was prescribed 6 to 10 modules to work with during the 10 week treatment period. First (intro) and last (relapse prevention) modules fixed. Others included cognitive restructuring (2), SAD (2), GAD (3), PD (2), AG, behavioural activation (2), applied relaxation, and sleep." "modules were available for download in PDF format." Compliance: “On average, participants were prescribed M=8.86 (SD=1.20, range 6‐10) modules, and typically completed M=7.96 modules (SD=2.37, range 2‐10 ) during the ten weeks of treatment. Fifty nine per cent of the participants finished all prescribed modules within the 10 week time limit.” |
|
| Outcomes |
General Symptoms: Beck Anxiety Inventory (BAI) Response: Clinical Global Impression (CGI): Improvement Depression: Montgomery and Asberg Depression Rating Scale (MADRS) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes | Funding: Swedish Council for Working Life and Social Research | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “by an online true random‐number service…” |
| Allocation concealment (selection bias) | Low risk | "...independent of the investigators and therapists." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "on the basis of these emails an assessment was made to judge whether the participant was ready to continue. If not, participant received instructions on what needed to be completed to be able to get to the next step..." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) "after a telephone interview by a blind assessor who had no earlier contact with the participants and no knowledge of to which group they had been randomly allocated." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: LOCF "Since the missing data at post‐treatment was only in the treatment group, repeated ANOVAs with conservative imputation according to the last observation‐carried‐forward method in case of missing data was used in the analysis of the immediate results." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Chung 2008.
| Methods |
Location: Seoul, South Korea Recruitment: Referral Exclusion rate: Unknown Randomised (N): 45 (27 intervention; 15 comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); ADIS (DSM‐IV) Duration (years): Unknown Age (years): 26.36 Sex (female): 39.5% Race (white): Unknown Medication (using at baseline): Unknown Education (years): 15.03 EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Too much shyness: A cognitive therapy for social phobia (Kwon, Cho, and Lee, 1998) Days of treatment: 42 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Home/ Anywhere Type of contact: Email Automated contact: N= 0 Provider contact: N=6 (duration unknown) Contact description: Group 1: “did their homework weekly, which was based on the contents of the book, and received feedback about their homework via e‐mail from the first author…Moreover, the BT 1 group could con‐ tact the therapist via e‐mail whenever they had a question about the homework.” Group 2: “just read the book for about 6 weeks without any feed‐ backs and were then debriefed with a semi‐ structured interview, in order to determine if they had correctly understood the content of the book at the end of the BT.” Intervention description: “information about social phobia…how to monitor social anxiety and record events in the Social Anxiety Record Form… identifying cognitive biases (e.g., catastrophic thinking) and changing dysfunctional beliefs…identify one’s underlying core beliefs and modify them… exposure techniques.” Compliance: "did their homework weekly, which was based on the contents of the book, and received feedback about their homework via e‐mail from the first author." |
|
| Outcomes |
Specific Symptoms: Social Interaction Anxiety Scale (SIAS); Social Phobia Scale (SPS) Response: Social Interaction Anxiety Scale (SIAS) |
|
| Notes | Funding: Korea Science and Engineering Foundation funded by the Korean government (Ministry of Education, Science, & Technology) (No. R01‐2008‐000‐11782‐0) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear "participants were randomly assigned" |
| Allocation concealment (selection bias) | Unclear risk | See "Sequence Generation." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk |
Provider contact: Yes Provider blind: No "received feedback about their homework via e‐mail from the first author" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=3 (11.11%) Comparison: N=4 (26.67%) Method of analysis: Available Case "the remaining 7 participants (two in BT 1, one in BT 2, and four in WL) dropped out" |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Donnan 1990.
| Methods |
Location: Northumberland, England Recruitment: Referral Exclusion rate: Unknown Randomised (N): 103 (51 intervention; 52 comparison) |
|
| Participants |
Disorder: Mixed (not specified); Unclear Duration (years): Unknown Age (years): 41.49 Sex (female): 74.26% Race (white): 58.25% Medication (using at baseline): 58.25% Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Treatment‐as‐usual Intervention name: Not named Days of treatment: 42 Author wrote: Yes Type of media: Book / Booklet Type of therapy: Relaxation Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: Unknown Contact description: No information was collected about the frequency of consultation. The initial questionnaire was followed by postal questionnaires at six weeks and three months. Intervention description: printed illustrated booklet (27 pages, approximately 4000 words) Psychoeducation, "...stopping anxiety developing...ways in which anxiety can be coped with better, including understanding the problem, dealing with the causes of the anxiety where possible, using relaxation, coping with worry, planning better coping, having realistic expectations, letting other people help, and dealing with panic." Relaxation tape. Compliance: N/A |
|
| Outcomes | None | |
| Notes | Funding: None acknowledged | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “The self‐help package was evaluated using a randomized controlled trial...Forty general practitioners in Northumberland agreed to recruit up to six patients each, randomly selecting three for the intervention group and three for the control group.” |
| Allocation concealment (selection bias) | High risk | "Each patient received an envelope at the end of the consultation with their general practitioner, which at random contained either the self‐help materials and a questionnaire or the questionnaire alone. The envelopes were similar but those containing the self‐help material were heavier." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "Each patient received an envelope at the end of the consultation with their general practitioner, which at random contained either the self‐help materials and a questionnaire or the questionnaire alone. The envelopes were similar but those containing the self‐help material were heavier." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=18 (35.29%) Comparison: N=9 (17.31%) Method of analysis: Available Case “Patients who dropped out of the intervention group had lower baseline scores than those who dropped out of the control group but there were no statistically significant differences. The characteristics of patients prior to loss to follow up at each time period were also examined and no statistically significant differences were found between the intervention and control groups.” |
| Selective reporting (reporting bias) | High risk | No trial registration number given. No data could be extracted for analysis. |
| Other bias | High risk | The study is very poorly described. |
Febbraro 1997a.
| Methods |
Location: Virginia, West Virginia and Pennsylvania, USA Recruitment: Advertising/ Internet Exclusion rate: Unknown Randomised (N): 98 (50 intervention; 48 comparison) |
|
| Participants |
Disorder: Panic disorder; ADIS (DSM‐IV) Duration (years): 6.94 Age (years): 44.4 Sex (female): 74.6% Race (white): 65.1% Medication (using at baseline): 65.1% Education (years): 14.1 EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: "Participants taking medication for anxiety or depression were allowed to participate provided they had been stabilised on the medication and dosage for at least four weeks and continued to experience full‐blown or limited symptom attacks…" Drug/Alcohol: "In addition, participants who were alcohol or substance dependent or had any type of psychotic disorder were also excluded from data analyses." Physical: "seizure disorder, kidney disease, stroke…emphysema or heart problems." |
|
| Interventions |
Comparison group(s): Wait‐list, Monitoring alone Intervention name: Coping with Panic: A Drug‐Free Approach to Dealing with Anxiety Attacks (G Clum; 1990) Days of treatment: 70 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: All participants had been exposed to assessment and feedback as part of an earlier study. The amount of contact listed here is unique to this part of the study and thus underestimates contact with this research team over the course of several years. "There was no contact with researchers at pretreatment assessment unless the pretreatment measures were not received by the experimenter within 7 days of their mailing. In this case, participants were contacted by telephone to ascertain if they had received the measures." Intervention description: 1) Self‐help alone, 2) Self‐help & monitoring. Included "(a) educating individuals about the etiology and nature of panic disorder; (b) teaching individuals a variety of cognitive and behavioral strategies that include relaxation, cognitive restructuring, breathing retraining, and exposure...Advice on implementing coping strategies is provided and homework assignments are incorporated to encourage active practice of these techniques." Compliance: Treatment knowledge was defined as being able to successfully answer at least 7 of 10 questions about principles discussed in the book. All participants were able to answer at least 70% of questions about the booklet correctly. |
|
| Outcomes |
Specific Symptoms: Panic Attack Cognitions Questionnaire (PACQ) General Symptoms: State‐Trait Anxiety Inventory (STAI): State Response: Panic Free Depression: Beck Depression Inventory (BDI) |
|
| Notes |
Funding: None acknowledged Unpublished data: Author provided details about study methods. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “Stratified assignment was utilized in order to ensure as much as possible that an equal number of participants from each condition in Phase 1 (i.e., assessment only, assessment with face‐to‐face feedback, assessment with mailed feedback, and wait‐list) were assigned to each condition in the present study.” "the best way to describe the method I used to assign participants to groups was to try and match groups as closely as possible" (personal communication) |
| Allocation concealment (selection bias) | High risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk |
Provider contact: No Provider blind: N/A Contact appears to be for assessment only and by post. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=18 (36%) Comparison: N=17 (35.42%) Method of analysis: Per protocol 98 assigned; 63 completers (17 booklet; 15 booklet plus monitoring; 13 monitoring; 18 wait list). 31 dropouts (11 No longer interested, 5 Project taking too long, 2 Moved, 13 Unknown). "Four additional participants were removed from the study for various reasons as well (e.g., beginning or changing medications during treatment [n = 2], beginning therapy during treatment [n = 1], or experiencing heart problems [n = 1])." "In addition, participants who were alcohol or substance dependent or had any type of psychotic disorder were also excluded from data analyses." |
| Selective reporting (reporting bias) | Low risk | No trial registration number given. Thesis likely includes all outcomes. |
| Other bias | Low risk | N/A |
Febbraro 1997b.
| Methods | As above. | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | High risk | |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | |
| Incomplete outcome data (attrition bias) All outcomes | High risk | |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | Low risk | |
Febbraro 2005.
| Methods |
Location: Iowa, USA Recruitment: Advertising/ Internet Exclusion rate: 46.07% Randomised (N): 48 (32 intervention; 16 comparison) |
|
| Participants |
Disorder: Panic Attacks; ADIS (DSM‐IV) Duration (years): 8.66 Age (years): 47.1 Sex (female): 73.3% Race (white): 53.33% Medication (using at baseline): 53.33% Education (years): 14.6 EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: "Participants taking medications to cope with panic symptoms and/or other psycho‐ logical problems needed to be stabilized on a particular dosage per their self‐report for four weeks prior to beginning this study." Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Attention/Monitoring Comparison description: Phone contact alone: like the intervention group, participants in the control group received phone calls at weeks 2, 4, 6 and 8. Intervention name: Coping with Panic: A Drug‐Free Approach to Dealing with Anxiety Attacks (G Clum; 1990) Days of treatment: 56 Author wrote: No Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Phone Automated contact: N=0 Provider contact: N=2 (30min) Contact description: “approximately one hour of phone contact with the principal investigator during the pre‐treatment assessment session….” Contact averaged; in one group "in addition to utilizing the book, participants were contacted via telephone at weeks 2, 4, 6, and 8...contact did not ever involve discussing how to implement coping strategies... If participants ever asked for such information, they would be referred to the book...The phone contact lasted no more than 15 minutes, as it was meant to be brief..." Intervention description: Two groups. Both received book "(1) educating individuals about the etiology and nature of panic attacks and panic disorder; (2) teaching individuals a variety of cognitive and behavioral strategies that include relaxation, cognitive restructuring, breathing retraining, and exposure to panic‐related situations; and (3) advising individuals on how to implement the above cognitive and behavioral strategies." One group received phone calls. Compliance: In one group "To monitor compliance, participants were asked how they were doing in reading the book, whether they had any questions about what they had read, and whether they were using any of the coping strategies suggested." |
|
| Outcomes |
Specific Symptoms: Panic Attack Cognitions Questionnaire (PACQ) Response: Panic Free |
|
| Notes |
Funding: None acknowledged Unpublished data: Febbraro provided details of randomisation process, number assigned to each group, and number of dropouts per group. Did not provide data for one person excluded from analyses for protocol violations. Assumed equal allocation of 48 participants. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Mechanical “participants meeting study inclusion criteria were randomly assigned to one of the following conditions...” "choosing group assignments out of a hat" (personal communication) |
| Allocation concealment (selection bias) | Low risk | See Sequence Generation. "briefly screened over the telephone by the principal investigator to determine eligibility... moved into the pre‐treatment phase of the study." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “to monitor their compliance in reading the book, provide some support, and answer any questions about the study” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=14 (43.75%) Comparison: N=2 (12.5%) Method of analysis: Per protocol Of these 48 participants, 30 completed the study, and 18 dropped out for various reasons... "If participants began some other form of psychological treatment during the study, they were allowed to continue in the study, but their data was removed from the final analyses. There was only one participant who began therapy during the course of the study." Author reports "Given that only one participant began therapy during the study thus resulting in their exclusion from the analyses, it is not possible to conduct some of the additional analyses you suggest" (personal communication). |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Fletcher 2005.
| Methods |
Location: Manchester, England Recruitment: Referral Exclusion rate: 91.71% Randomised (N): 30 (15 intervention; 15 comparison) |
|
| Participants |
Disorder: Mixed (Mean HADS Anxiety score over the minimal clinical cutoff of 8 (average >10) ); No diagnostic interview (questionnaire only) Duration (years): Unknown Age (years): 38.6 Sex (female): 76.67% Race (white): Unknown Medication (using at baseline): Unknown Education (years): 12.27 EXCLUSIONS Depression: Yes Psychotherapy: No restrictions reported Medication: "Use of antidepressant medication was not an exclusion criterion, but data gathered about patient use of antidepressants was incomplete, mainly due to patient recall issues." Drug/Alcohol: "not primary diagnosis of substance misuse" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Kennedy and Lovell (2002). A Handy Guide to Managing Depression and Anxiety: what should I do? Days of treatment: 84 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: Continued to receive treatment by a GP, but no support using the booklet. Intervention description: Pocket sized. "...general advice about lifestyle, professional help and treatments available for anxiety and depression. Part two uses cognitive behavioural techniques...helps the reader to recognize thoughts, physical symptoms and behaviour and also to identify problems and set goals. The second part also teaches self‐help interventions such as behavioural activation, relaxation, problem solving, exposure and cognitive therapy." Compliance: “Process/satisfaction data were collected from the experimental group. There was a high level of satisfaction with the self‐help, with all parts of the book being rated as useful or highly useful by over 50% of the patients (except for ‘evaluating your progress’ for which several patients gave feedback that 12 weeks was too soon to evaluate progress)." |
|
| Outcomes |
General Symptoms: Hospital Anxiety and Depression Scale (HADS): Anxiety Depression: Hospital Anxiety and Depression Scale (HADS): Depression |
|
| Notes |
Funding: None acknowledged. Authors wrote the booklet but do not derive income from it. Unpublished data: Fletcher (now Archer) provided SPSS file with anonymous data, but was unable to locate mid‐point data. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Mechanical “The 30 patients were randomly allocated to one of two groups, self‐help intervention (n=15) or waiting list control (n=15). Randomization was conducted using sealed plain opaque envelopes inside 15 of which was a slip of paper stating 'control group', whilst the other 15 contained a slip stating 'experimental group'. All the envelopes were equal in terms of size, design and weight.” |
| Allocation concealment (selection bias) | Low risk | “The 30 envelopes were then mixed up and given to the administrator of the Primary Care Mental Health Team, who randomly slotted an envelope into each of the 30 consecutively numbered study packs. The packs were then allocated by the principal investigator.” |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk |
Provider contact: No Provider blind: N/A “The patients were given a brief description of the book and advised to read it at their own pace.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: LOCF '"The main analysis used an independent samples t‐test to detect significant differences between the intervention group and the control group on week 12 scores using intention‐to‐treat analysis, with missing data replaced by last observation carried forward (LOCF). Therefore, data collected at weeks 0 or 6 were used in the analyses when data at week 12 were not available." "The two significant differences found between completers and those lost‐to‐follow‐up were (1) age, which was higher in the latter group (t=3.62; df, 28; p = .001), and (2) CORE total score, which was also higher (t=2.74; df, 28, p = .011)." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Unclear risk | N/A |
Fraser 2001.
| Methods |
Location: Tasmania, Australia Recruitment: Advertising/ Internet Exclusion rate: 41.18% Randomised (N): 30 (15 intervention; 15 comparison) |
|
| Participants |
Disorder: Specific Phobia; CIDI (DSM‐III R) Duration (years): Unknown Age (years): 32.55 Sex (female): 93.33% Race (white): 0% Medication (using at baseline): 0% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current and previous therapy restricted Medication: "not taking psychotropic medication" Drug/Alcohol: "alcohol or illicit drug abuse problem" Physical: N/A |
|
| Interventions |
Comparison group(s): Self‐help (Exposure) Comparison description: 3 sessions of the same programme. Intervention name: CAVE (Smith 1997) Days of treatment: 21 Author wrote: Yes Type of media: Computer Type of therapy: Exposure Location used: Clinic/ Surgery Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=6 (30min) Contact description: “The therapist stayed with the participant for the first five minutes of the treatment to answer any questions. No self‐exposure homework instructions were given by the therapist, the program or by handout.” Intervention description: 6 sessions received twice weekly. "...assist an animated screen figure to overcome his/her fear of spiders...There are four levels on the program, which model exposure to a spider picture, a plastic spider, a dead spider and a live spider, in a household setting. An on‐screen 'anxiety thermometer' models the screen figure’s initial anxiety on approach of spider stimuli, and habituation with the accumulation of approach behaviours." Compliance: “Process measures analysed were: (a) the time spent with a spider stimulus visible, on each level; (b) the number of enactments of vicarious touching of the spider at each level; and (c) the score rate per 5‐minute epoch as a summary measure of overall vicarious exposure activity." "Mann‐Whitney U tests showed no significant differences between the groups’ final session on any variable." Homework activities 6‐session versus 3‐session: PT=2.3 (1.3) vs. 2.2 (1.9), FU=2.7 (1.5) vs. 2.3 (1.8). |
|
| Outcomes |
Specific Symptoms: Fear Questionnaire (FQ): Global Phobia Behaviour Test (Level): Behavioural Approach Test: Level Behaviour Test (Symptoms): Behavioural Approach Test: Subjective Units of Distress Disability: Work and Adjustment Rating Scale (WARS) |
|
| Notes | Funding: None acknowledged | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk |
Method: Unclear “The participant was randomly allocated to one of the two treatment conditions…" See Allocation Concealment. |
| Allocation concealment (selection bias) | High risk | “Participants who did not complete the treatment program were replaced by new participants allocated to the same treatment group.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “The therapist stayed with the participant for the first five minutes of the treatment to answer any questions. No self‐exposure homework instructions were given by the therapist, the program or by handout.” |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) “A replication study with blind assessment and a control group is warranted.” |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=3 (20%) Comparison (other): N=4 (26.67%) Method of analysis: Per protocol “Seven participants (three‐session group n=4; six‐session group n=3) did not complete the full treatment program, reportedly due to: work commitments (n=1); travel commitments (n=3); the participant’s opinion that they were cured (n=1); and because they felt the program was not helpful (n=1).” |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. “Assessments were repeated immediately following the final treatment session (posttreatment) and four weeks after treatment (follow‐up). These comprised BAT, SUDS, SPQ, FQ Main, FQ Global, PT Problem, PT Total, WARS Total, and HWQ.” |
| Other bias | Low risk | “Participants who did not complete the treatment program were replaced by new participants allocated to the same treatment group" |
Furmark 2009a.
| Methods |
Location: Uppsala, Sweden Recruitment: Advertising/ Internet Exclusion rate: 59.48% Randomised (N): 120 (80 intervention; 40 comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); SCID (DSM‐IV) Duration (years): Unknown Age (years): 36.13 Sex (female): 67.5% Race (white): 6.67% Medication (using at baseline): 6.67% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "if prescribed drugs for anxiety or depression, the dosage had to be constant for 3 months before the treatment onset and kept constant throughout the study" Drug/Alcohol: "substance misuse" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Comparison description: “The waiting‐list control (WLC) group controlled for time and repeated assessments during the initial 9‐week period. Participants had no contact with each other or with the study team during their waiting period except for conditional reminders by email or SMS to complete the weekly assessment of the LSAS‐SR.” Intervention name: Social Fobi‐Effektiv Hjalp med Kognitiv Beteendeterapi [Social Phobia ‐ Effective Help with CBT] Days of treatment: 63 Author wrote: Yes Type of media: Mixed Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=Unknown Provider contact: N=4.5 (67.5min) Contact description: “in all groups, some participants received neutral reminders, sent by email or SMS, to complete the LSAS‐SR ICBT:” "15min per week giving email feedback to each participant" Intervention description: 1) The "pure" bibliotherapy (Bib) arm (40/80 intervention) received the manual by post. 2) 186 pages divided into nine modules for use over the internet. "Modules were also sent by post on a weekly basis..." Psychoeducation, cognitive restructuring, exposure, attention training, social skills, relapse prevention. "had access to an online discussion forum...Discussions were surveyed but the study personnel did not take part in them." Compliance: “each module…ended with a short quiz to check adherence” "in cases of missing data, brief, neutral reminder was sent 24h later by email, and if necessary followed by another reminder as autogenerated short text message" For Furmark 2009a and 2009b: completed modules 1 (100%), 2 (95%), 3 (92.5%), 4 (85%), 5 (80%), 6 (77.5%), 7 (72.5%), 8 (70%), 9 (62.5%). |
|
| Outcomes |
Specific Symptoms: Liebowitz Social Anxiety Scale, self‐rated (LSAS‐SR) General Symptoms: Beck Anxiety Inventory (BAI) Response: Liebowitz Social Anxiety Scale, self‐rated (LSAS‐SR); Social Interaction Anxiety Scale (SIAS); Social Phobia Scale (SPS); Social Phobia Screening Questionnaire (SPSQ) Depression: Montgomery and Asberg Depression Rating Scale (MADRS) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes |
Funding: Swedish Research Council. "The manual was released as a self‐help book for the Swedish market after completion of the study." T.F., A.H., E.S., P.Ca. and G.A. receive royalties for authoring the self‐help book Trial 1: Combined ICBT and Bib groups to form the intervention group. Averaged outcomes and treatment characteristics, including number and duration of contact. 5‐year follow‐up includes data only for the treatment group. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “Randomisation was performed by an independent third party using an online true random‐number service (www.random.org).” |
| Allocation concealment (selection bias) | Low risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "...giving email feedback to each participant. There were 13 internet therapists in the study, of whom 6 were licensed clinical psychologists and 7 were clinical psychology students in their last semester of the 5‐year master’s degree programme. The students had clinical supervision during the trial. Participants were randomly allocated to their therapist." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: LOCF “one each from the pure bibliotherapy and waiting‐list groups, withdrew immediately after randomisation because of personal reasons and one additional participant (ICBT group) did not provide post‐treatment data. The waiting‐list control group received delayed treatment after 9 weeks (see below) but 3 individuals withdrew...” "missing data were replaced by the last obtained score (pre‐ or post‐treatment), i.e. last observation carried forward." "all participants were asked to complete post‐treatment and follow‐up assessments, regardless of how many treatment modules they had completed." |
| Selective reporting (reporting bias) | Low risk |
Trial registration number: NCT01145690 All outcomes reported. |
| Other bias | Low risk | N/A |
Furmark 2009b.
| Methods |
Location: Uppsala, Sweden Recruitment: Advertising/ Internet Exclusion rate: 59.48% Randomised (N): 115 (86 intervention; 29 comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); SCID (DSM‐IV) Duration (years): Unknown Age (years): 34.7 Sex (female): 67.83% Race (white): 13.91% Medication (using at baseline): 13.91% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "if prescribed drugs for anxiety or depression, the dosage had to be constant for 3 months before the treatment onset and kept constant throughout the study" Drug/Alcohol: "substance misuse" Physical: N/A |
|
| Interventions |
Comparison group(s): Applied relaxation (self‐help) Comparison description: “Participants in the internet‐delivered applied relaxation (IAR) group followed an applied relaxation manual, which had been adapted for self‐help use via the internet and evaluated (e.g. for panic disorder)...The structure of the manual was the same as in the ICBT and Bib groups, i.e. the text was divided into nine modules containing information and exercises, and participants completed one module per week.” "had access to an internet therapist during the 9‐week treatment period." Intervention name: Social Fobi‐Effektiv Hjalp med Kognitiv Beteendeterapi [Social Phobia ‐ Effective Help with CBT] Days of treatment: 63 Author wrote: Yes Type of media: Mixed Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=Unknown Provider contact: N=3 (45min) Contact description: “in all groups, some participants received neutral reminders, sent by email or SMS, to complete the LSAS‐SR.” One third "had no contact with the study team except for the usual online assessments before, immediately after, and 1 year after treatment" One third "had access to an internet therapist during the 9‐week treatment period." "Email correspondence occurred weekly...instruction on what needed to be completed to proceed to the next module...therapists spent approximately 15 min per week..." Intervention description: 1 AND 2) Two bibliotherapy groups received the manual by post. 57/86 had online discussion group. "had access to an online discussion forum...Discussions were surveyed but the study personnel did not take part in them. 3) The other arm received 186 pages divided into nine modules for use over the internet." "Modules were also sent by post on a weekly basis..." Psychoeducation, cognitive restructuring, exposure, attention training, social skills, relapse prevention. Compliance: “each module…ended with a short quiz to check adherence” "in cases of missing data, brief, neutral reminder was sent 24h later by email, and if necessary followed by another reminder as autogenerated short text message" For Furmark 2009a and 2009b: completed modules 1 (100%), 2 (95%), 3 (92.5%), 4 (85%), 5 (80%), 6 (77.5%), 7 (72.5%), 8 (70%), 9 (62.5%). |
|
| Outcomes |
Specific Symptoms: Liebowitz Social Anxiety Scale, self‐rated (LSAS‐SR) General Symptoms: Beck Anxiety Inventory (BAI) Response: Liebowitz Social Anxiety Scale, self‐rated (LSAS‐SR); Social Interaction Anxiety Scale (SIAS); Social Phobia Scale (SPS); Social Phobia Screening Questionnaire (SPSQ) Depression: Montgomery and Asberg Depression Rating Scale (MADRS) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes |
Funding: Swedish Research Council. "The manual was released as a self‐help book for the Swedish market after completion of the study." T.F., A.H., E.S., P.Ca. and G.A. receive royalties for authoring the self‐help book Trial 2: Combined ICBT, Bib, BibDG groups to form the intervention group. Averaged outcomes and treatment characteristics, including number and duration of contact. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “Randomisation was performed by an independent third party using an online true random‐number service (www.random.org).” |
| Allocation concealment (selection bias) | Low risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "...giving email feedback to each participant. There were 13 internet therapists in the study, of whom 6 were licensed clinical psychologists and 7 were clinical psychology students in their last semester of the 5‐year master’s degree programme. The students had clinical supervision during the trial. Participants were randomly allocated to their therapist." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: LOCF 0 lost to post‐treatment; 14 intervention 2 control lost to follow‐up. Applies to Furmark 2009a and 2009b: "Ten participants (4.3%) withdrew from the study after the first (n = 6) or second (n = 4) treatment week, the main reasons being lack of time or motivation and personal problems..." "For all randomised participants, missing data were replaced by the last obtained score (pre‐ or post‐treatment), i.e. last observation carried forward." "In accordance with the intention‐to‐treat principle, all participants were asked to complete post‐treatment and follow‐up assessments, regardless of how many treatment modules they had completed." |
| Selective reporting (reporting bias) | Low risk |
Trial registration number: NCT01145690 All outcomes reported. |
| Other bias | Low risk | N/A |
Ghosh 1984.
| Methods |
Location: London, England Recruitment: Referral Exclusion rate: 42.11% Randomised (N): 88 (59 intervention; 29 comparison) |
|
| Participants |
Disorder: Mixed (AG, SAD, SP); Clinical Interview (ICD‐9) Duration (years): 11 Age (years): 36 Sex (female): 74.65% Race (white): 0% Medication (using at baseline): 0% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: If patients were on drugs they were asked to gradually come off them before being included in the trial." Drug/Alcohol: N/A Physical: "uncontrolled hypertension, cardiac or severe respiratory conditions" |
|
| Interventions |
Comparison group(s): Individual Exposure Comparison description: “Therapist‐instructed patients had the same treatment approach and worked only in discussion with a therapist (AG)." Intervention name: Living With Fear (Marks, 1980) Days of treatment: 70 Author wrote: Yes Type of media: Mixed Type of therapy: Exposure Location used: Other Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=6 (67min) Contact description: 40 minutes, 4.2 hours and 3.2 hours. "book‐instructed patients were only seen three times during the treatment phase and thrice during the follow‐up period; computer‐ and therapist‐instructed patients were seen at weekly intervals during the treatment phase and thrice during follow up..." "Participants could contact the psychiatrist at any time, though none did so. All patients were treated individually." All received an explanation of avoidance, exposure, and homework, and they were told to enlist relatives and friends to help. Intervention description: 2 groups combined: (i) "given a copy of the book ‘Living with Fear’ (Marks 1978), which explains step by step how patients can help themselves by slowly coming off sedatives and alcohol and devising a detailed programme of graded exposure..." (ii) "3‐10 treatment sessions of 40‐60 minutes..." "computer was programmed to "discus' exposure tasks from a hierarchical list of patients' phobic situations. At the end of the ‘interview' it printed out an ‘exposure homework' diary..." Compliance: Homework diaries. Diary data are recorded and analysed. |
|
| Outcomes |
Specific Symptoms: Fear Questionnaire (FQ): Agoraphobia General Symptoms: Fear Questionnaire (FQ): Anxiety Depression; Fear Questionnaire (FQ): Anxiety Depression, assessor rated Disability: Work and Adjustment Rating Scale (WARS) |
|
| Notes |
Funding: Medical Research Council Project Grant Unpublished data: Marks identified Ghosh 1984 as a preliminary report of the participants in the 1987 and 1988 papers. Unable to provide further information. The 1988 paper says the therapist group was added 3 months into the study. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk |
Method: Unclear “Patients were randomly assigned to one of three self‐exposure treatment groups" "imbalance in numbers arose because (a) originally the study had been planned to compare only computer and book‐instructed self‐exposure, and the therapist‐instructed group was added 3 months into the trial" |
| Allocation concealment (selection bias) | High risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “book‐instructed patients were only seen three times during the treatment phase and thrice during the follow‐up period; computer‐ and therapist‐instructed patients were seen at weekly intervals during the treatment phase and thrice during follow up...” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “Patients were assessed before and after treatment and at 3 and 6 months follow‐up by an experienced behavioural psychotherapist, who was blind to the treatment condition.” |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=7 (11.86%) Comparison: N=10 (34.48%) Method of analysis: Unclear Dropouts occurred "before completing an adequate trial of treatment." "Seventy‐five patients completed treatment, but included 4 who had not been randomized and so these were omitted from the analysis. Of the 71 patients who completed the randomized trial, all except one in the computer‐instructed group completed six months' follow‐up." |
| Selective reporting (reporting bias) | High risk | No trial registration number given. “Most statistical tests are not reported for the whole sample. The only results are for the subgroup with AG.” |
| Other bias | High risk | Numbers randomised and analysed differ among reports. A 1987 report is presented as a stand‐alone trial, but the author confirms it reports data for a subgroup of the earlier trial. One group was added 3 months into the study. Dropout figures assume equal allocation, but allocation may not have been equivalent. |
Gilroy 2000.
| Methods |
Location: Tasmania, Australia Recruitment: Advertising/ Internet Exclusion rate: 13.46% Randomised (N): 45 (15 intervention; 15, 15 comparisons) |
|
| Participants |
Disorder: Specific Phobia; CIDI (DSM‐III R) Duration (years): Unknown Age (years): 33.11 Sex (female): 100% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current and previous therapy restricted Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Muscle relaxation (self‐help), Individual exposure Comparison description: 1) "An audiotape of progressive muscle relaxation...The long and short versions of Jacobson's complete deep muscle relaxation were repeated twice to fill the 45‐minute..." 2) "five pictorial representations of spiders and then moving onto a sequence of steps of increasing fearfulness similar to those in the BAT. Throughout treatment, progression to a higher step was based on three successful attempts at the previous step, a SUDS rating of below 20...." Intervention name: CAVE (Smith 1997) Days of treatment: 42 Author wrote: Yes Type of media: Computer Type of therapy: Exposure Location used: Clinic/ Surgery Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=3 (15min) Contact description: Pretreatment assessment comprised two sessions. The first session involved obtaining written consent, demographic details, and completion of the CIDI... "Each participant then received three 45‐minute treatment sessions..." "In the initial session the therapist stayed with the participant for approximately 5 minutes to ensure the participant was comfortable using the pro‐ gram. The therapist then left the participant to work through the program." Intervention description: The program instructed participants in vicarious exposure for spider phobia. Participants used a point‐and‐ click method with the computer mouse to guide a person" (a screen figure) through a house. The participant could direct the screen figure into scenarios depicting a spider picture, a plastic spider, a dead spider, and a live spider in various rooms." 3 x 45‐min sessions every two weeks. Compliance: Measured exposure homework at 33 months. |
|
| Outcomes |
Specific Symptoms: Fear Questionnaire (FQ): Global Phobia Behaviour Test (Level): Behavioural Approach Test: Level Behaviour Test (Symptoms): Behavioural Approach Test: Symptom Rating Disability: Work and Adjustment Rating Scale (WARS) |
|
| Notes |
Funding: None acknowledged Unpublished data: Gilroy described the method of randomisation, demographic details and estimated contact with participants, including time required for consent and assessment (email, 19 May 2009). |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk |
Method: Computer/Online The first 45 participants were randomly assigned to one of the three treatment conditions. See Allocation Concealment. |
| Allocation concealment (selection bias) | High risk | "Five participants (4 from relaxation condition, 1 from live exposure condition) did not complete treatment due to time constraints (3), moving interstate (1), and having already undergone prior relaxation treatment (1). These participants were replaced with new participants who were allocated to the same treatment groups as those who had not completed treatment." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) The assessor, a master's student in psychology (LG), delivered both the assessment and treatment sessions. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) The assessor, a master's student in psychology (LG), delivered both the assessment and treatment sessions. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=1 (6.67%) Comparison (muscle relaxation): N=0 (0%) Comparison (individual exposure): N=2 (13.33%) Method of analysis: Per protocol Dropouts replaced. 14 intervention, 13 face‐to‐face and 15 relaxation subjects completed questionnaires at 147 week follow‐up. 13 intervention 11 face‐to‐face and 8 relaxation subjects completed the BAT at 147 week follow‐up. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. BAT results for the relaxation group at 33 months are missing, but other outcomes appear to be reported clearly and completely. |
| Other bias | High risk | Dropouts were replaced, thus violating the randomisation. |
Gould 1993a.
| Methods |
Location: Virginia, USA Recruitment: Advertising/ Internet Exclusion rate: 69.16% Randomised (N): 33 (12 intervention; 12, 9 comparison) |
|
| Participants |
Disorder: Panic disorder w/ AG; ADIS (DSM‐III R) Duration (years): Unknown Age (years): 35.7 Sex (female): 64.52% Race (white): 18.18% Medication (using at baseline): 18.18% Education (years): 14.26 EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: Subjects taking medication for anxiety or depression were allowed to participate if they had been stabilized on the medication for at least four weeks and continued to have panic symptoms (n = 6)." Drug/Alcohol: N/A Physical: "having been diagnosed by a physician as having seizure disorder, kidney disease, stroke...emphysema, heart attack, or chronic hypertension." |
|
| Interventions |
Comparison group(s): Wait‐list, Inidivudal CBT Comparison description: 1) "WL subjects were told that they would have to wait 7 weeks for their treatment to begin." "Subjects who did not mail in their weekly data were reminded to do so by telephone." 2) Individual therapy "plans were derived primarily from material in Coping with Panic." "Subjects met with a therapist twice per week for 4 weeks for a total of eight 1‐hour individual therapy sessions targeting their panic attacks. There were four graduate‐level therapists in this study." Intervention name: Coping with Panic: A Drug‐Free Approach to Dealing with Anxiety Attacks (G Clum; 1990) Days of treatment: 28 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Phone Automated contact: N=0 Provider contact: N=2 (30min) Contact description: Total experimenter contact time for subjects in the WL and BT groups was for assessment purposes only and was 2.5 and 3.0 hours, respectively; ITGIC subjects required 10.5 hours. " In all groups, subjects who did not complete weekly measures were reminded by phone. "contacted at weeks 2 and 4 by the experimenter to assess their progress in reading the book. Each phone call lasted approximately 10 minutes, during which the experimenter followed a written protocol and did not answer questions..." Intervention description: 2‐week monitoring and assessment (common to all groups, beginning in week 5 for the wait‐list). "...the etiology and nature of panic disorder; (2) teaching them a variety of cognitive and behavioral strategies that include relaxation, cognitive restructuring, breathing retraining, and exposure; and (3) advising them on how to implement these strategies." Compliance: Experimenters questioned subjects about specific material covered in the book to ascertain if subjects were reading the book and to determine their level of comprehension. A score of 70% on this assessment was considered evidence that the subject was reading the book. |
|
| Outcomes |
Specific Symptoms: Mobility Inventory for Agoraphobia (MIA) General Symptoms: Anxiety Sensitivity Index (ASI) Response: Panic Free Depression: Beck Depression Inventory (BDI) |
|
| Notes |
Funding: None acknowledged Unpublished data: Author provided information about the conduct of the study. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk |
Method: Unclear The paper explains: "Subjects were matched on level of avoidance and then randomly assigned to one of the three experimental conditions." The author explains: "individuals who agreed to be in the study and were eligible were alternately assigned to groups" (personal communication). |
| Allocation concealment (selection bias) | High risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "Experimenters questioned subjects about specific material covered in the book to ascertain if subjects were reading the book" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=1 (8.33%) Comparison (wait‐list): N=1 (8.33%) Comparison (individual CBT): N=0 (0%) Method of analysis: Per protocol Only 2 subjects dropped out: 1 from the WL group and 1 from the BT group. The subject from the WL group reported that she had to move to a different state to seek employment and could no longer continue in the study. The subject from the BT condition completed all the dependent measures of the study, but was not included in the analyses because she had failed to read the book. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Limited symptom panic attacks not reported. |
| Other bias | Low risk | N/A |
Gould 1995.
| Methods |
Location: Virginia, USA Recruitment: Advertising/ Internet Exclusion rate: 76.56% Randomised (N): 33 (17 intervention; 16 comparison) |
|
| Participants |
Disorder: Panic disorder; ADIS (DSM‐III R) Duration (years): 10.3 Age (years): 36.2 Sex (female): 84% Race (white): 44% Medication (using at baseline): 44% Education (years): 13.8 EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: "Subjects taking medication for anxiety or depression were allowed to participate if they had been stabilized on the medication for at least 4 weeks and continued to have panic symptoms, and if they recorded their medication usage throughout the study (n Drug/Alcohol: "chronic use of alcohol, drug dependence or abuse.." Physical: "any of the following conditions: seizure disorder, kidney disease, stroke...emphysema, myocardial infarction, or chronic hypertension." |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Coping with Panic: A Drug‐Free Approach to Dealing with Anxiety Attacks (G Clum; 1990) Days of treatment: 28 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Phone Automated contact: N=0 Provider contact: N=2 (30min) Contact description: Subjects who failed to mail in their weekly data were reminded to do so by telephone contact from one of the study's personnel. "The total time spent with researchers/therapists for each group of subjects was 2.5 hours for the WL group and 3.0 hours for the SH group, including the initial diagnostic evaluation." "SH subjects were told that their progress in reading the book would be assessed at mid‐ and posttreatment by telephone." Intervention description: 2‐week monitoring and assessment (common to all groups, beginning in week 5 for the wait‐list). "...the etiology and nature of panic disorder; (2) teaching them a variety of cognitive and behavioral strategies that include relaxation, cognitive restructuring, breathing retraining, and exposure, and (3) advising them on how to implement these strategies." "videotape was a 15‐minute role‐played therapy session" "an audiotape that taught the progressive muscle relaxation" Compliance: "SH subjects were instructed to complete and mail in the same four weekly measures as WL subjects. In addition, they were instructed to fill out a weekly Practice Record..." "Subjects also kept a weekly log of the amount of time they spent practicing specific coping techniques, including self‐exposure. This self‐monitoring procedure was not included as a dependent measure but rather was included as an inducement to practice coping strategies." |
|
| Outcomes |
Specific Symptoms: Mobility Inventory for Agoraphobia (MIA) Response: Panic Free |
|
| Notes |
Funding: None acknowledged Unpublished data: Author provided information about the conduct of the study. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk |
Method: Unclear At the end of the baseline period, all subjects were matched on their pretreatment level of avoidance score and randomly assigned to either the SH or WL groups. The author explains: "subjects were alternately placed in the two groups" (personal communication) |
| Allocation concealment (selection bias) | High risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "SH subjects were told that their progress in reading the book would be assessed at mid‐ and posttreatment by telephone." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=5 (29.41%) Comparison: N=3 (18.75%) Method of analysis: Per protocol “...the baseline period, 3 subjects decided not to be in the study...prior to their learning their treatment assignment.” "Among the WL dropouts, 1 subject reported not having the time to keep records and the other gave no reason for termination. Among SH subjects, 1 decided he needed to see a psychiatrist and wanted medication for his problems, 1 terminated for no discernible reason and did not return our telephone calls, and 1 never read the book." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. A similar study by the same authors (Gould 1993) included the BDI. |
| Other bias | Low risk | N/A |
Granado 2007.
| Methods |
Location: Sao Paulo, Brazil Recruitment: Advertising/ Internet Exclusion rate: 84.38% Randomised (N): 25 (13 intervention; 12 comparison) |
|
| Participants |
Disorder: Specific Phobia; SCID (DSM‐IV) Duration (years): 23 Age (years): 31.3 Sex (female): Unknown Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Attention/Monitoring Comparison description: Placebo Intervention name: SLAT: Spiderless Arachnophobia Therapy Days of treatment: 28 Author wrote: Yes Type of media: Internet Type of therapy: Exposure Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=4 (duration unknown) Contact description: To assess progress during the treatment, placebo and treatment subjects underwent the BAT (including the SUDS) each week. Intervention description: "patients attend a computer presentation of images that, while not being spiders, have a subset of the characteristics of spiders" "patient was instructed to run the presentation twice a day at home preferably during moments in which she/he was not tired or under stress." "To assess progress during the treatment, placebo and treatment subjects underwent the BAT (including the SUDS) each week." Compliance: Prior to each presentation run, the patient was given one question to answer at the end of the run. Every week these data were checked out in order to verify the rate of cooperation of patients and to encourage noncooperative patients, if any. In all subjects, the cooperation was satisfactory and no statistics were deemed necessary to measure the rate of cooperation. |
|
| Outcomes |
Specific Symptoms: Fear of Spider Questionnaire (FSQ) Behaviour Test (Level): Behavioural Approach Test: Level Behaviour Test (Symptoms): Behavioural Approach Test: Subjective Units of Distress |
|
| Notes | Funding: supported by a CNPq Fellowship 154342/2006‐8 and, previously, by a FAPESP Fellowship 03/08804‐0 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “randomly divided into two groups” |
| Allocation concealment (selection bias) | Unclear risk | “randomly divided into two groups” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “To assess progress during the treatment, placebo and treatment subjects underwent the BAT (including the SUDS) each week.” |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) “To assess progress during the treatment, placebo and treatment subjects underwent the BAT (including the SUDS) each week.” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropout. |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Greist 2002.
| Methods |
Location: Salt Lake City, UT; Wheat Ridge, CO; Gainesville, FL; Houston, TX; Toronto, ON; Raleigh, NC; Worcester, MS; Atlanta, GA, USA/Canada Recruitment: Advertising and referral Exclusion rate: Unknown Randomised (N): 218 (74 intervention; 75, 69 comparisons) |
|
| Participants |
Disorder: OCD; SCID (DSM‐IV) Duration (years): 22 Age (years): 39 Sex (female): 42% Race (white): 49% Medication (using at baseline): 49% Education (years): 14.63 EXCLUSIONS Depression: Yes Psychotherapy: No restrictions reported Medication: "51% had not taken an SRI for at least 2 weeks prior to prescreening... The remainder were taking an SRI at or above an adequate minimum stable dose…The study did not allow dose adjustments or other prescription psychotropics." Drug/Alcohol: "in the past 6 months, alcohol or substance abuse" Physical: "unstable medical conditions" |
|
| Interventions |
Comparison group(s): Relaxation, Individual Exposure Comparison description: 1) "asked to perform progressive relaxation exercises for at least an hour daily and to keep daily relaxation diaries…" 2) 11 weekly, 1‐hour (or longer) sessions. Intervention name: BT STEPS Days of treatment: 70 Author wrote: Yes Type of media: Computerised Phone Type of therapy: Exposure Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=12 Provider contact: N=3 (45min) Contact description: All participants met with a clinician for 15 minutes at the end of weeks 2, 6, and 10 after starting treatment to assess improvement, safety, and appropriateness of continued participation. "Patients get feedback on their progress via the calls and reports mailed to them weekly". Intervention description: 9‐step, computer‐driven IVR [interactive voice response] system that allows patients with OCD to telephone from home and progress through a self‐paced workbook." Education and assessment, daily self‐exposure, relapse prevention. Compliance: The mean length of telephone calls to BT STEPS was 8.6 minutes…YBOCS improvement correlated significantly with more calls (mean ± SD = 22.5 ± 71.6... "The number of self‐exposure homework sessions completed by patients in the BT STEPS groups (mean ± SD = 9.9 ± 35.2) correlated significantly with mean YBOCS improvement…" "61% of calls were made between 5:00 p.m. and 9:00 a.m. or on weekends." |
|
| Outcomes |
Specific Symptoms: Yale‐Brown Obsessive‐Compulsive Scale (Y‐BOCS) Response: Clinical Global Impression (CGI): Improvement; Patient Global Impression (PGI): Improvement Depression: Hamilton Depression Rating Scale, self‐rated (HAM‐D S) Disability: Work and Social Adjustment Scale (WSAS) |
|
| Notes |
Funding: Cathryn Clary was employed by Pfizer. Isaac Marks and Lee Baer received royalties from BT STEPS, owned by Healthcare Technology Systems. Greist, Kobak, Wenzel, Hirsch and Mantle were employed by HTS. Follow‐up paper notes that severity moderates response. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “After screening, subjects were randomly assigned…” |
| Allocation concealment (selection bias) | Unclear risk | “After screening, subjects were randomly assigned…” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) In addition to contact in the face‐to‐face therapy group, "All participants met with a clinician for 15 minutes at the end of weeks 2, 6, and 10…." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) "Ratings were determined by an interviewing clinician (not the therapist) using paper‐and pencil scales (CGI) and by the patient using paper‐and‐pencil (TRT‐X, PSQ) or telephone interactive voice response (IVR) scales* (YBOCS, PGI, WSAS HAM‐D). A subsample of 90 patients was also rated on the clinician‐administered YBOCS at baseline and end‐point by a rater blind to treatment condition." |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=19 (25.68%) Comparison (relaxation): N=9 (12%) Comparison (exposure): N=14 (20.29%) Method of analysis: Per protocol Subjects whose total YBOCS scores fell by 25% or more during assessment (placebo responders, N=16) or who did not complete assessment tasks (N=5), violated the protocol (N=12), or withdrew (N=2) were excluded. "176 had at least 1 evaluable post‐week 0 visit and were included in the end‐point intent‐to‐treat analyses..." "the last available postrandomization rating was input to endpoint for subjects who stopped prematurely." |
| Selective reporting (reporting bias) | High risk | No trial registration number given. "A subsample of 90 patients was also rated on the clinician‐administered YBOCS…" Data for goals completed not reported. Expectation (TRT‐X) and satisfaction (PSQ) not reported (but available from author on request). |
| Other bias | High risk | A run‐in undermined the randomisation; 24% of the intervention group were excluded from further analyses: "One hundred eighty‐three reached week 0 after 2 weeks' assessment (baseline visit: 57 in the BT STEPS group, 59 in the clinician guided behavior therapy group, and 67 in the relaxation group)." |
Grime 2004.
| Methods |
Location: London, England Recruitment: Workplace Exclusion rate: 64.85% Randomised (N): 48 (24 intervention; 24 comparison) |
|
| Participants |
Disorder: Mixed (Mean HADS Anxiety score in the moderate range (i.e. mean >11) ); No diagnostic interview (questionnaire only) Duration (years): Unknown Age (years): 39 Sex (female): 58.33% Race (white): 20.83% Medication (using at baseline): 20.83% Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: "All participants continued whatever care they were otherwise receiving (conventional care), details of which were recorded" Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Treatment‐as‐usual Comparison description: 21% received the intervention outside the trial. Intervention name: Beating the Blues (Ultrasis; http://www. ultrasis.com) Days of treatment: 56 Author wrote: Yes Type of media: Computer Type of therapy: CBT Location used: Workplace Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=8 (125min) Contact description: Author estimates that the first interaction was 30‐45 minutes and subsequent visits were 5‐10 minutes (as in Proudfoot, and as estimated for other clinic‐based studies). When participants failed to attend, the researcher contacted them by phone. "A weekly progress report of distress self‐ratings and suicidal ideation is generated for the user and for the supervising clinician. " Intervention description: “‘Beating The Blues’ is an interactive computerized CBT programme. Its cognitive components explore automatic thoughts, thinking errors and distraction, challenging unhelpful thinking, core beliefs and attributional style...activity scheduling, task breakdown, problem solving, sleep management, relaxation training and biofeedback, planning and prioritizing and graded exposure. Cognitive and behavioural exercises are prescribed at the end of each module, and debriefed at the start of the next." Compliance: “Of those randomized to ‘Beating The Blues’, 16 completed all eight sessions of the programme, one completed six sessions, two completed four sessions, one completed three sessions and four completed two sessions. Reasons for not completing the programme included attrition, inability to commit the necessary time, and a desire not to continue.” |
|
| Outcomes |
General Symptoms: Hospital Anxiety and Depression Scale (HADS): Anxiety Depression: Hospital Anxiety and Depression Scale (HADS): Depression |
|
| Notes |
Funding: None acknowledged Unpublished data: Grime provided unpublished manuscript, demographics, qualitative feedback. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online Eligible participants giving written, informed consent, were randomized according to a sequence generated by a random number table |
| Allocation concealment (selection bias) | Low risk | Randomisation codes in sealed envelopes were opened sequentially, after collection of baseline demographic, absence and psychological data. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) Participants were seen at the start and end of each session. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=8 (33.33%) Comparison: N=1 (4.167%) Method of analysis: Available Case Analysis was performed on an intention to treat basis... "Of the eight who did not complete the programme, four completed follow up questionnaires and four were lost to follow up. One participant completed all eight sessions of ‘Beating The Blues’, but none of the follow up questionnaires." Four control participants were excluded from absenteeism analyses as they were absent for (i) unemployment and (ii) maternity leave. |
| Selective reporting (reporting bias) | Low risk | No trial registration number given. Author provided unpublished dissertation. |
| Other bias | Low risk | N/A |
Hassan 1992.
| Methods |
Location: Leeds, England Recruitment: Advertising/ Internet Exclusion rate: 5% Randomised (N): 42 (11 intervention; 9, 22 comparison) |
|
| Participants |
Disorder: Specific Phobia; Clinical Interview (DSM‐III R) Duration (years): 20.34 Age (years): 28.74 Sex (female): 78.95% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐list, Individual exposure Comparison description: (i) Exposure with modelling and live spiders. When all photos were viewed with little or no fear, live spiders were introduced. Concluded when participants could perform target behaviours with clear ease and confidence. Tarantulas used. (N=10.5). (ii) Exposure plus relaxation (N=10.5). (iii) Wait‐list (N=10). [First two groups combined for analysis.] (Intervention strategies similar, method of delivery varied.) Intervention name: Computer‐Based Symbolic Modelling Days of treatment: 18 Author wrote: Yes Type of media: Computer Type of therapy: Exposure Location used: Clinic/ Surgery Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=5 (20min) Contact description: Therapist was present in the treatment room, but no help was offered or requested by clients. 20 minute session followed completion of computer modelling; researcher had live spiders in boxes and explained the BAT verbally without demonstration. Intervention description: Computerised exposure. Information, relaxation. Video and photographs of a woman approaching spiders (like BAT). Rate controlled by participants. Twice weekly 40‐min sessions. Anxiety Rating Scale displayed when "Stop" pressed, and subjects saw relaxation instructions or listened to classical music. Session terminated if stopped twice for an item. Resumed where previous session ended. Debriefing preceded post‐treatment assessment. Compliance: Intervention participants completed 5 sessions on average, duration of 3.34 hours. By comparison, graded exposure and live modeling (combined for analysis) lasted 4.78 and 4.45 sessions and involved 3.19 and 2.97 hours of therapist contact. |
|
| Outcomes |
Specific Symptoms: Spider Phobia Questionnaire (SPQ) Behaviour Test (Level): Behavioural Approach Test: Level Response: Behavioural Approach Test: Completed; Spider Phobia Questionnaire (SPQ) |
|
| Notes |
Funding: None acknowledged Unpublished data: Contacted Leeds, which provided the dissertation, but unable to contact the author directly. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear Using a matched‐group design technique, clients were first stratified into groups on four on the basis of their BAT scores. This was done by ranking all clients in terms of their BAT scores in ascending order, the first group of four in the list were taken...then randomly assigned to the four conditions of the study. |
| Allocation concealment (selection bias) | High risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) Participants were seen at the start and end of each session. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) Participants were seen at the start and end of each session. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=1 (9.09%) Comparison (wait‐list): N=1 (11.11%) Comparison (individual exposure): N=2 (9.09%) Method of analysis: Available Case Three clients who attended assessment but did not attend any further sessions were not included in the analyses. One client withdrew who thought her condition was "beyond treatment.” Estimated number of participants assuming equivalent group sizes. |
| Selective reporting (reporting bias) | Low risk | No trial registration number given. The composite score is not reported, but other measures appear to be reported completely and clearly. Data extracted from thesis likely complete. |
| Other bias | Low risk | N/A |
Hazen 1996.
| Methods |
Location: Winnipeg, Canada Recruitment: Referral Exclusion rate: 9.4% Randomised (N): 117 (32 intervention; 28, 28 comparison) |
|
| Participants |
Disorder: Panic disorder; SCID (DSM III) Duration (years): 8.6 Age (years): 37.12 Sex (female): 72.6% Race (white): 46.99% Medication (using at baseline): 46.99% Education (years): 11.36 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "current pharmacological treatment for panic disorder, with the exception of low doses of benzodiazepines (equivalent of 20 mg diazepam or less) or stable doses of antidepressants (i.e., prescribed for at least 6 months and stable dose for at least 3 mont Drug/Alcohol: "substance abuse" Physical: "physician agreement regarding participation. Exclusion criteria included: (1) presence of organic disease which might be related to panic disorder or interfere with participation in the study" |
|
| Interventions |
Comparison group(s): Wait‐list, Group CBT Comparison description: 1) Wait‐list. 2) "thirteen 1.5 hour sessions were conducted over a fourteen‐week period. Sessions were structured around the content of the self‐help manual, and included discussion of reading and practice homework assignments." Intervention name: Coping with Panic: A Drug‐Free Approach to Dealing with Anxiety Attacks (G Clum; 1990) Days of treatment: 98 Author wrote: No Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: “Potential participants were initially assessed with a 30‐minute structured telephone interview. Respondents who appeared to meet the inclusion criteria were then interviewed in person by a clinician experienced in assessing anxiety disorders.” Intervention description: “The content of the treatment program included psycho‐educational information about anxiety, and cognitive‐behavioral treatment strategies, including relaxed breathing, progressive muscle relaxation, cognitive restructuring, and graduated exposure to feared situations. Subjects assigned to the self‐help manual condition were instructed to complete one section of the self‐help manual weekly for 14 weeks.” Compliance: N/A |
|
| Outcomes |
Specific Symptoms: Fear Questionnaire (FQ): Agoraphobia General Symptoms: Anxiety Sensitivity Index (ASI) Response: Clinical Global Impression (CGI): Improvement |
|
| Notes |
Funding: Manitoba Health Research Council Unpublished data: Walker provided slides from presentations showing number randomised to each group. Described randomisation process and demographics. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Mechanical “..we would recruit a block of participants – say eight or ten – then that block would be assigned to one of the four conditions…we would have four slips of paper with the four conditions, and blindly pull one from a hat…We would then recruit for the next block. When that block was ready, we would pull a strip randomly (for the remaining three conditions) and assign to that condition.” |
| Allocation concealment (selection bias) | Low risk | “If we were screening a lot of people at once, we would also try to match up the groups a bit in terms of gender and severity (before they were randomized).” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) Comparison group received face‐to‐face treatment. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “Subjects also attended a post‐treatment evaluation interview, during which several rating scales, including the Clinical Global Improvement scale, were administered by the first author, who served as the independent assessor for the treatment study. Over the course of the study, the assessor remained blind to subjects’ treatment group status in order to ensure that unbiased ratings were made." |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=5 (15.63%) Comparison (wait‐list): N=1 (3.57%) Comparison (group CBT): N=2 (7.14%) Method of analysis: Available Case Unpublished presentation clarifies that 11 participants were assigned and not analysed. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Unable to extract Frequency of PAs, BDI. |
| Other bias | Low risk | N/A |
Heading 2001.
| Methods |
Location: Tasmania, Australia Recruitment: Advertising/ Internet Exclusion rate: 22.4% Randomised (N): 45 (15 intervention; 16, 14 comparison) |
|
| Participants |
Disorder: Specific Phobia; CIDI (DSM‐IV) Duration (years): Unknown Age (years): 34.9 Sex (female): 95% Race (white): 0% Medication (using at baseline): 0% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: No restrictions reported Medication: "not taking psychotropic medication" Drug/Alcohol: "substance‐abuse problem" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐list, Individual exposure Comparison description: 1) Wait list, 2) "The treatment rationale focused on habituation/extinction of the anxiety response (Gilroy et al., 2000)...No relaxation exercises, modelling, or behavioural experiments aimed at disconfirming specific beliefs were used in the exposure sessions. No exposure homework instructions were given to the participant." Intervention name: CAVE (Smith 1997) Days of treatment: 1 Author wrote: Yes Type of media: Computer Type of therapy: Exposure Location used: Clinic/ Surgery Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=1 (20min) Contact description: The therapist stayed with the participant for the first 5 minutes of the treatment, to answer any questions. The program was reset by the therapist every 45 minutes to total 3 hours. Intervention description: Participants are asked to assist an animated screen figure to overcome his/her fear of spiders, using a computer mouse to direct the figure through different exposure scenarios. An on‐screen “anxiety thermometer” models habituation with the accumulation of approach behaviours, while a score displays the figure’s progress towards a target score of 2000." Compliance: There were no significant differences in scores on the HWQ for self‐directed homework between the LGE, CAVE, and waiting‐list groups at both post‐treatment and follow‐up assessment. Overall, participants reported few self‐initiated homework activities: mean for LGE 2.8 (SD 1.2), CAVE 2.0 (SD .8), and waiting list 2.0 (SD 1.8). |
|
| Outcomes |
Specific Symptoms: Fear Questionnaire (FQ): Global Phobia Behaviour Test (Level): Behavioural Approach Test: Level Behaviour Test (Symptoms): Behavioural Approach Test: Subjective Units of Distress Disability: Work and Social Adjustment Scale (WSAS) |
|
| Notes |
Funding: None acknowledged Unpublished data: Heading, Kirkby and Gilroy contacted. Gilroy described the baseline measures and estimated contact with participants. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear The participant was randomised to one of the three conditions, with the treatment session 1 week after the pre‐treatment assessment. |
| Allocation concealment (selection bias) | Unclear risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) The therapist stayed with the participant for the first 5 minutes of the treatment. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) "The researcher accompanied the participant during all steps to advise of the next step, to record SUDS, and to score steps. Participants were debriefed following the BAT. BATs are considered highly sensitive measures of treatment change (de Beurs, Lange, Van Dyck, Blonk, & Pieter, 1991)." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=3 (20%) Comparison (wait‐list): N=1 (6.25%) Comparison (individual exposure): N=1 (7.14%) Method of analysis: Available Case Five participants with‐ drew from the study (CAVE = 2, waiting list = 3) due to time commitments, before receiving treatment. "One participant (LGE) withdrew following the post‐treatment assessment." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Hedman 2011a.
| Methods |
Location: Stockholm, Sweden Recruitment: Advertising and referral Exclusion rate: 30.77% Randomised (N): 81 (40 intervention; 41 comparison) |
|
| Participants |
Disorder: Health Anxiety; MINI (DSM‐IV) Duration (years): 20.99 Age (years): 39.05 Sex (female): 74.07% Race (white): 38.27% Medication (using at baseline): 38.27% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current and previous therapy restricted Medication: "constant dosage 2 months prior to treatment if on prescribed medication for anxiety or depression and agree to keep dosage constant throughout the study" Drug/Alcohol: "not currently fulfilling the diagnostic criteria for substance misuse according to the MINI" Physical: "no serious somatic disease as assessed by a physician based on a review of medical records and the anamnesis from the diagnostic assessment interview" |
|
| Interventions |
Comparison group(s): Attention/Monitoring Comparison description: “The control condition consisted of an online discussion forum where participants could send messages anonymously to each over a period of 12 weeks…the rationale for employing this control condition design was to ensure a basic control for attention and the possible anxiety‐alleviating effect of sharing one’s distress with others. Participants were encouraged to discuss their health anxiety and helpful ways of coping with it, and to provide support to others...” Intervention name: Not named Days of treatment: 84 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=12 (108min) Contact description: Estimated 1 weekly contact based on the following: "The role of the therapist was mainly to provide feedback regarding all homework and to grant access to the succeeding treatment modules; however, the participant could contact the therapist at any time and expect a reply within 24h. In addition, therapists encouraged inactive participants to continue the treatment work. The participant and therapist had no face‐to‐face or telephone contact during the treatment. On average therapists spent 9min (s.d. = 5.6) weekly per participant." Intervention description: “118 pages, divided into 12 modules” with homework exercise...emphasising the role of avoidance and safety behaviours, internal focus and interpretations of bodily sensations as signs of serious illness as maintaining factors of hypochondriasis. In addition, the treatment included mindfulness training as a means of acquiring skills to help participants expose themselves...” "an online discussion forum that enabled anonymous contact with other participants receiving internet‐ based CBT." Compliance: “The average number of completed modules in internet‐based CBT was 9.1 (s.d. = 3.3). Six participants completed fewer than six modules and were considered non‐completers...The most common reason reported for not completing treatment was lack of time. In the control group, the average number of postings was 16.1 (s.d. = 19.3). Thirty‐nine of 41 participants in the control group posted at least one message.” |
|
| Outcomes |
Specific Symptoms: Illness Attitude Scale (IAS) General Symptoms: Anxiety Sensitivity Index (ASI); Beck Anxiety Inventory (BAI) Response: Clinical Global Impression (CGI): Improvement Recovery: No longer met criteria for diagnosis Depression: Montgomery and Asberg Depression Rating Scale (MADRS) Disability: Global Assessment of Functioning Scale (GAF) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes | Funding: Karolinska Institutet | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “The randomisation procedure was managed by an external person not involved in the study. A true random number service (www.random.org) was used to ensure complete randomness.” |
| Allocation concealment (selection bias) | Low risk | “The random sequence was generated after inclusion of participants to ensure that assignment of intervention was concealed from the assessing psychologists and researchers involved in the study.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “The role of the therapist was mainly to provide feedback regarding all homework and to grant access to the succeeding treatment modules…” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “The clinical psychologists performing the assessments were masked to treatment status and when summoned to clinician assessment all participants were instructed not to mention which intervention they had received.” "In two instances masking was broken...no significant association between assessors’ guess and actual treatment allocation (P50.58–0.052)." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: No Dropout |
| Selective reporting (reporting bias) | Low risk |
Trial registration number: NCT00828152 All outcomes reported. |
| Other bias | Low risk | N/A |
Hedman 2011b.
| Methods |
Location: Stockholm, Sweden Recruitment: Advertising and referral Exclusion rate: 45.22% Randomised (N): 126 (64 intervention; 62 comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); SCID (DSM‐IV) Duration (years): 20.96 Age (years): 35.35 Sex (female): 35.71% Race (white): 24.6% Medication (using at baseline): 24.6% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current and previous therapy restricted Medication: "have constant dosage two months prior to treatment of any prescribed medication for anxiety or depression and agree to keep dosage constant throughout the study" Drug/Alcohol: "not currently meet the diagnostic criteria for substance abuse" Physical: N/A |
|
| Interventions |
Comparison group(s): Group CBT Comparison description: Heimberg RG, Becker RE (2002) Cognitive‐behavioral group therapy for social phobia. Basic mechanisms and clinical strategies. New York: Guilford Press. "an initial individual session followed by 14 group sessions over 15 weeks. The individual session prepared the participant to begin group treatment sessions and included a rationale for group treatment. Each group session was 2.5 hours long, including a 15 minute break. Groups were lead by two therapists and had six to seven participants." Intervention name: Not named Days of treatment: 105 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=17.4 (82.5min) Contact description: “...mainly to provide feedback regarding home work and to grant access to the treatment modules...could contact the therapist at any time and expect a reply within 24 hours during week days...no face‐to‐face or telephone contact ...instruction to the internet therapists was to have the ambition to restrict time spent on each patient to less than 10 minutes per week.” "spent 5.5 minutes (SD = 3.6) weekly per patient. The corresponding amount of time in CBGT was 50 minutes (2.5 h sessions with two therapists and 6 patients)....ICBT therapists sent 17.4 messages..." Intervention description: “stresses the importance of avoidance and safety behaviors as well as misinterpretations of social events and internal focus as maintaining factors of SAD...15 text modules, each covering a specific theme (e.g., exposure or cognitive restructuring) completed with a homework component” Compliance: “The average number of completed modules in ICBT was 9.33 (SD=4.95) of 15. Fifty‐ one participants in ICBT (80%) completed at least 5 modules and 19 (29.7%) completed all...” Comparison: "all reviewed sessions were judged to have been conducted in accordance with the treatment manual." "9.40 (SD=4.87) out of a possible total of 15. Fifty participants in CBGT (81%) attended at least five sessions and 17 (27%) attended all..." |
|
| Outcomes |
Specific Symptoms: Liebowitz Social Anxiety Scale, self‐rated (LSAS‐SR) General Symptoms: Anxiety Sensitivity Index (ASI); Beck Anxiety Inventory (BAI) Response: Clinical Global Impression (CGI): Improvement; Liebowitz Social Anxiety Scale, self‐rated (LSAS‐SR) Recovery: No longer met criteria for diagnosis Depression: Montgomery and Asberg Depression Rating Scale (MADRS) Disability: Global Assessment of Functioning Scale (GAF) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes | Funding: Stockholm County Council (Nils Lindefors) and the Bror Gadelius Fund (Erik Hedman) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “A true random number service (http://www.random.org) was used to ensure randomization.” |
| Allocation concealment (selection bias) | Low risk | "The randomization procedure involved two external persons not involved in the study; one provided randomization data and the other monitored that no manipulation of treatment allocation was performed by the research group...The random sequence was generated after inclusion of participants to ensure that assignment of intervention was concealed from assessing psychiatrists and researchers of the study." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk |
Provider contact: Yes Provider blind: No “most messages to patients are very brief entailing the core feed‐back that the homework was successfully completed and the next treatment module is accessible” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) "...participants were instructed not to mention which treatment they had received during the post‐ treatment and follow‐up interviews. After completing the interviews, the assessing psychiatrists guessed allocation..." "On two occasions participants accidentally mentioned their treatment allocation status to the assessor, and in other two occasions it was deemed necessary to break the blinding because of the need to assess increased depressive symptoms during treatment." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=1 (1.57%) Comparison: N=0 (0%) Method of analysis: Available Case “On the CGI‐I scale, missing values were replaced with 'no change'. As a complement, the social anxiety measures were also analyzed based on the sample of completers only." At post‐treatment, 1 intervention and 0 controls failed to provide self‐report data, 5 and 10 failed to complete clinician assessment. At follow‐up, 4 intervention and 3 controls failed to provide self‐report data, 10 and 11 failed to complete clinician assessment. |
| Selective reporting (reporting bias) | High risk |
Trial registration number: NCT00564967 The protocol lists three measures (WQ, TIC‐P, SSP) that are not reported. "During treatment, the LSAS‐SR and the suicide ideation item of MADRS‐S were administered on a weekly basis." |
| Other bias | Low risk | N/A |
Hellström 1995.
| Methods |
Location: Uppsala, Sweden Recruitment: Advertising and referral Exclusion rate: 0% Randomised (N): 52 (42 intervention; 10 comparison) |
|
| Participants |
Disorder: Specific Phobia; ADIS (DSM‐III R) Duration (years): 19.7 Age (years): 26.7 Sex (female): 100% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: "no disease of the heart or lungs" |
|
| Interventions |
Comparison group(s): Individual Exposure Comparison description: Based on the description given by Ost (1989a), this method includes a combination of gradual exposure and modelling. The treatment is described in detail in Ost et al. (1991). The previous trial included 126.2 (30.5) minutes contact. Included modeling and live spiders. Sessions videotaped and replayed to patients. (Intervention strategies similar, method of delivery varied.) Intervention name: 1) Living with Fear (Marks, translated) or 2) Not named (also used in Ost 1991) Days of treatment: 14 Author wrote: Yes Type of media: Book / Booklet Type of therapy: Exposure Location used: Other Type of contact: Phone Automated contact: N=0 Provider contact: N=1 (duration unknown) Contact description: Averaged clinic visits across groups. Unspecified phone contact (all groups) between treatment and 1‐year assessment. "The program involved 7 time periods during 6 months with specific forms that the patients should fill in and send to the therapist at certain intervals. Upon receiving the form the therapist either phoned the patient or wrote a letter to her in order to provide feedback." Intervention description: Group 1 "instructed to follow a 30 page manual specifically written for spider phobics used in an earlier study (0st et al., 1991)...based on the one‐session therapist‐directed exposure..." Group 2 "general manual (Marks, 1978) consists of 23 pages beginning with questions for the patient and a description of the exposure procedure. Both groups were split into those who used the book at (a) home or (b) clinic. For clinic groups, spiders were provided. Compliance: N/A |
|
| Outcomes |
Specific Symptoms: Fear Survey Schedule General Symptoms: Beck Anxiety Inventory (BAI); State‐Trait Anxiety Inventory (STAI) Response: Behavioural Approach Test: Completed Depression: Beck Depression Inventory (BDI) |
|
| Notes |
Funding: Swedish Medical Research Council Unpublished data: Contacted Hellstrom and Ost. The lead author did not respond. Ost provided data for another study. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear '"After the pre‐treatment assessment, the patients were randomly assigned to 5 different treatment groups" |
| Allocation concealment (selection bias) | Unclear risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Half the intervention group interacted with researcher/clinician (not blind) throughout the trial. Therapists treated participants in each group.” |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) The therapists who conducted the treatments were the authors of this paper. "The patient's degree of phobic severity was rated by the clinician" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=4 (9.52%) Comparison: N=0 (0%) Method of analysis: Imputed “Four patients in the manual groups at the clinic (3 in S‐C and 1 in G‐C) stopped treatment prior to the post‐treatment assessment, but since this was in effect comparable to patients in the two manual at home groups who performed less than two 2‐hour sessions prior to the post‐treatment assessment, it was not counted as attrition. For ethical reasons, we offered these four patients therapist‐directed one session treatments and therefore their results are included in the follow‐up data, but as estimates based on the post‐treatment data." |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Behavioural test, self‐rated anxiety, and clinician‐rated anxiety are presented as graphs, and significance tests are reported. However, there is not enough information to include these outcomes in meta‐analysis. Variance not reported for physiological measures. |
| Other bias | Low risk | N/A |
Holdsworth 1996.
| Methods |
Location: Northumberland, England Recruitment: Referral Exclusion rate: Unknown Randomised (N): 106 (53 intervention; 53 comparison) |
|
| Participants |
Disorder: Mixed (Mean scores on the GHQ‐12 were above accepted threshold for caseness, and anxiety scores were higher than depression scores ); Other Duration (years): Unknown Age (years): Unknown Sex (female): Unknown Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Treatment‐as‐usual Intervention name: Managing Anxiety and Depression: A Self‐help Guide (Holdsworth and Paxton, 1999) Days of treatment: 30 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: “no contact by participants with researchers.” Intervention description: “a 42 page manual containing a range of treatment techniques for anxiety, depression and related complaints. The material is arranged and presented within the theoretical framework of the Three‐Systems‐Model (Lang, 1968; Rachman, 1978; Hugdahl, 1981). This model analyses psychological functioning in terms of thought, feeling and behaviour...selection of exercises designed to change what they have identified as most troubling them.” Compliance: Asked about use of the booklet at 3 months. |
|
| Outcomes | None included. | |
| Notes |
Funding: The Mental Health Foundation, The Design and Communications Department of Northumberland Mental Health NHS Trust. Unpublished data: Paxton had no information. Holdsworth provided details of randomisation, but was unable to provide details about baseline or outcomes. The Mental Health Foundation was contacted: "I have received a response from our Head of Research. Unfortunately, they have both said that they do not recognise this report. It was suggested that this could be a report the Foundation supported but it wasn’t catalogued, which is very unusual, as all of our publications are recorded with The British Library and can be located using their ISBN number." |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Unclear "a randomised controlled trial in the primary care setting." "Equivalent levels of stress were controlled for at the outset in the experimental and control groups using the Social Readjustment Rating Scale." It is not clear how this was done, but the author indicates that a random assignment list was administered using numbered sealed envelopes that were indistinguishable on weight and handling (personal communication). |
| Allocation concealment (selection bias) | Low risk | "recruits were handed a sealed envelope which contained either a questionnaire and SAE only or these items together with a copy of Managing Anxiety and Depression: A Self‐Help Guide. The general practitioner did not know what each envelope contained." It is not clear how these could have been indistinguishable, but the author indicates that they were (personal communication). |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) GPs recruited and treated patients. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=23 (43.39%) Comparison: N=21 (39.62%) Method of analysis: Per protocol “At the outset of the trial, 106 patients were recruited by 40 general practitioners. At the close of the trial, 62 patients had successfully completed all questionnaires: 32 in the control group and 30 in the intervention group." Only participants who completed the first questionnaire were sent questionnaires at 1 and 3 months. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. It was not possible to extract most outcome measures because means are reported without measures of variance and only significant p values are reported. |
| Other bias | Unclear risk | It is unclear how many participants were assigned to each group; we assumed equal allocation. |
Houghton 2008.
| Methods |
Location: Internet, USA Recruitment: Advertising/ Internet Exclusion rate: 77.98% Randomised (N): 231 (116 intervention; 115 comparison) |
|
| Participants |
Disorder: Generalised Anxiety Disorder; Unclear Duration (years): Unknown Age (years): 44 Sex (female): 100% Race (white): Unknown Medication (using at baseline): Unknown Education (years): 15.24 EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: "currently in good health as acknowledged by their primary care physician" |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Mindfulness‐Based Stress Reduction Program (J Kabat‐Zinn) Days of treatment: 56 Author wrote: No Type of media: Internet Type of therapy: Muscle Relaxation Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: None reported. Intervention description: breathing exercises, mindfulness meditation, and yoga stretching Compliance: N/A |
|
| Outcomes | General Symptoms: State‐Trait Anxiety Inventory (STAI) | |
| Notes | Funding: None acknowledged | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear "The participants were then randomized to either the treatment or the wait list control group." |
| Allocation concealment (selection bias) | Unclear risk | "Participants were notified as to which group they were randomized to after they completed the pretests." |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unclear if there was contact with researchers or clinicians. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=66 (%) Comparison: N=65 (%) Method of analysis: Unclear "At the end of eight weeks all 116 participants in the experimental group were sent the post‐tests and 84 returned the tests. The data was randomly selected for analysis from the participants who completed the post‐tests (n = 50 experimental group, n = 50 wait list control group, (See Figure 1). Also at the completion all 57 wait list control participants who returned the post‐tests were given access to the MBSR information." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Johnston 2011.
| Methods |
Location: Sydney, Australia Recruitment: Advertising/ Internet Exclusion rate: 48.22% Randomised (N): 139 (93 intervention; 46 comparison) |
|
| Participants |
Disorder: Mixed (GAD, PD, SAD); MINI (DSM‐IV) Duration (years): Unknown Age (years): 41.62 Sex (female): 58.8% Race (white): 29% Medication (using at baseline): 29% Education (years): 13.91 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "if taking medication (people taking benzodiazepines were excluded), had been taking the same dose for at least 1 month and did not intend to change that dose during the course of the program" Drug/Alcohol: "not using illicit drugs or consuming more than three standard drinks a day" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Comparison description: Wait list. Intervention name: Anxiety Program (enhanced) Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email & Phone Automated contact: N=20.01 Provider contact: N=16.4 (69.39min) Contact description: weekly telephone or email/asynchronous messaging contact with the Clinician or Coach, and regular automated reminder and notification emails Coach/Clinician: 7.56/7.54 phone calls, 8.88/8.83 mutual written contacts, 19.37/20.43 automated contacts, 69.09/69.59 minutes. Intervention description: 1) Clinician‐assisted, 2) Coach‐assisted. "Eight online lessons; a summary/homework assignment for each lesson…access to additional written resources that included guidelines about managing low mood, improving sleep, and answers to frequently asked questions…also provided with access to de‐identified vignettes written by participants in previous iCBT programs covering topics relevant to each of the eight lessons.” Compliance: 4% withdrew before the programme began or did not start. 72% completed all lessons. |
|
| Outcomes |
General Symptoms: Depression Anxiety Stress Scales ‐ 21 Item (DASS‐21) Depression: Patient Health Questionnaire (PHQ‐9) Disability: Sheehan Disability Scale (SDS) |
|
| Notes |
Funding: National Health and Medical Research Council of Australia: Dora Lush Priority PhD scholarship, the New South Wales Institute of Psychiatry, and the Australian Rotary Health Research Fund Request disaggregated data by disorder and data for each intervention. Did not use disorder‐specific measures reported only for the total sample. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “randomized via a true randomization process (www.random.org)” |
| Allocation concealment (selection bias) | Low risk | "generated by an independent person, to either CL, CO or Control groups. The allocation sequence preceded pre‐treatment diagnostic interviews and was concealed from LJ and JS" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “weekly telephone or email/asynchronous messaging contact with the Clinician or Coach, and regular automated reminder and notification emails” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=4 (4.30%) Comparison: N=4 (8.70%) Method of analysis: LOCF "Thirty‐two of 43 (74%) CO and 35/46 CL (76%) group participants completed all eight lessons within the 10‐week program; intention‐to‐treat (ITT) design and missing data was addressed by carrying forward the first available data (baseline‐observation carried‐forward; BOCF" |
| Selective reporting (reporting bias) | High risk |
Trial registration number: ACTRN12610000242022 NEO‐5 and Agoraphobia Cognitions Questionnaire not reported. Treatment groups collapsed for analyses. Outcomes not reported for specific diagnoses. |
| Other bias | Low risk | N/A |
Jones 2002a.
| Methods |
Location: Manchester, England Recruitment: Referral Exclusion rate: Unknown Randomised (N): 40 (20 intervention; 20 comparison) |
|
| Participants |
Disorder: Health Anxiety; Other Duration (years): Unknown Age (years): 50.3 Sex (female): Unknown Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: "Half of the patients involved were also suffering from a medically diagnosed, physically‐based problem" |
|
| Interventions |
Comparison group(s): Treatment‐as‐usual Intervention name: Understanding Health Anxiety: A Self‐help Guide for Suffers and their Families (Kuchemann, C & D Sanders; 1999) Days of treatment: 28 Author wrote: No Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=4 (180min) Contact description: Assessment and weekly sessions 1‐hour (personal communication). 45 min intervention and 15 min feedback. Intervention description: “…consistent with the cognitive‐behavioural model of health anxiety. The aim of the booklet is to educate the reader on how heath worries come about, what keeps them going and to provide guidelines on what can be done." Compliance: After four weeks, the intervention group "confirmed that they had read the self‐help booklet and completed the exercises." |
|
| Outcomes |
Specific Symptoms: Health Anxiety Questionnaire (HAQ) General Symptoms: State‐Trait Anxiety Inventory (STAI) |
|
| Notes |
Funding: None acknowledged Unpublished data: Jones was contacted and provided information about the conduct of the study. She was unable to describe the randomisation process (see the Risk of Bias table). |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear They were then randomly allocated to two groups Asked about the number assigned to each group, Jones replied "I think it was 50‐75", but 40 participants are described in the paper. |
| Allocation concealment (selection bias) | Unclear risk | “At the first interview all participants were given information about the study, then asked to complete the questionnaires assessing their health anxiety." Author reports "The participants were assigned to each group as they were referred to me they were assigned a number and assigned to each group by numbers." (personal communication.) "The participants were randomly assigned to each group as they were referred and before I had looked at the referral." (personal communication.) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) Weekly sessions 1‐hour (personal communication) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk |
Not analysed at post‐treatment Intervention: N=2 (10%) Comparison: N=1 (5%) Method of analysis: Unclear Statistical tests indicate that 37 people are included in each of the post‐treatment analyses. Details for dropouts are not reported; assumed groups were initially equal in size. |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | High risk | Description of randomisation and allocation very poor. Number assigned unclear; we assumed participants were allocated evenly to groups. |
Kenardy 2003.
| Methods |
Location: Fife, SCO and Brisbane, AU, UK/Australia Recruitment: Advertising and referral Exclusion rate: 55.71% Randomised (N): 186 (50 intervention; 45 comparison) |
|
| Participants |
Disorder: Panic disorder; SCID (DSM‐IV) Duration (years): 5.95 Age (years): 36.8 Sex (female): 75.5% Race (white): 30.35% Medication (using at baseline): 30.35% Education (years): 11.9 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "All patients taking medication at the time of entry must have been on a stable dose for 3 months and must have been willing and able to remain on a stable regime for 3 months during the course of treatment." Drug/Alcohol: "no evidence of alcohol or drug dependence" Physical: "...no evidence of cardiovascular disease, asthma, epilepsy, or pregnancy or intention to become pregnant during the course of the study." |
|
| Interventions |
Comparison group(s): SH + Individual CBT versus CBT alone Comparison description: Six 1‐hr sessions. "The manuals provided specific detail of content to be covered within each session, including session agendas, information to be presented, homework exercises, and specific therapeutic procedures (e.g., interoceptive exposure, relapse prevention). The CBT approach was based on panic control treatment (Barlow, Cerney, & Klosko, 1989) that incorporated the cognitive and behavioral theories of panic (e.g., Barlow et al., 1989; Clark, 1986)..." Intervention name: Based on Panic Control Treatment (Barlow, Cerney and Klosko 1989) Days of treatment: 42 Author wrote: Yes Type of media: Computer Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=5.9 (354 min, common to both groups) Contact description: 90 min assessment (personal communication). "On average, patients completed 5.9 therapy sessions in CBT6‐CA and 5.9 sessions in CBT6. In the CBT6‐CA condition, patients continued to carry the palmtop computer for the remaining 6 weeks, after which it was returned." Intervention description: Participants in both group received the same face‐to‐face therapy. Intervention group also "The palmtop computer used in the CBT6‐CA was the Hewlett Packard 200LX, which weighs about 300g...programmed to signal the participant five times daily...to prompt the practice of the therapy components. The computer program included a self‐statement module, a breathing control module, and a new exposure module incorporating both situational exposure and interoceptive exposure." Compliance: On average, participants in each group completed 5.9 therapy sessions. "Adherence data was complex but overall we achieved 96.8% adherence to treatment protocol. Scotland had 98.5% and Australia had 95.1%." (personal communication) |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ) General Symptoms: State‐Trait Anxiety Inventory (STAI): Trait Response: Panic Free Depression: Beck Depression Inventory (BDI) Quality of Life: Medical Outcomes Study Short Form (SF‐36) |
|
| Notes |
Funding: National Health Service and Medical Research Council, Australia, and from the Chief Scientist's office, Scottish Executive, Scotland Unpublished data: Kenardy provided details about recruitment, demographics, randomisation, allocation concealment, numbers of participants in analyses, contact with participants. He also provided data for the BDI and the SF‐36. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk |
Method: Unclear "Patients who dropped out were replaced." "Additional cases were randomly assigned in the next “cohort” to make up the shortfall, we had four cohorts which recruited and randomised about 20 each but this number varied depending on the dropouts. In the last cohort we just went with what we had." (Personal communication) |
| Allocation concealment (selection bias) | High risk | "Patients who dropped out were replaced." Administered by a third party (research assistant). "Additional cases were randomly assigned in the next “cohort” to make up the shortfall, we had four cohorts which recruited and randomised about 20 each but this number varied depending on the dropouts. In the last cohort we just went with what we had." (personal communication) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “each therapist treating approximately equal proportions of patients in each of the three treatment conditions.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=15 (30%) Comparison: N=11 (24.44%) Method of analysis: Per protocol 12% did not complete at least three sessions of treatment or provide "adequate data." "and were defined as dropouts. An additional 13 participants were lost to follow‐up, leaving 93 participants with 9‐month follow‐up analysis." "An intent‐to‐treat analysis was also conducted in which all cases with available pretreatment data were carried forward...The intent‐to‐treat analysis was limited to 3‐months posttreatment because it was judged that extrapolation of pretreatment data to the 6‐month follow‐up was untenable." |
| Selective reporting (reporting bias) | Low risk | No trial registration number given. BDI and SF‐36 are not reported in the paper, but received from the author. |
| Other bias | High risk | “Patients who failed to receive at least three sessions of their respective course of treatment or who failed to provide adequate pretreatment and endpoint data were defined as dropouts. Patients who dropped out were replaced.” |
Kiely 2002.
| Methods |
Location: Herefordshire, England Recruitment: Referral Exclusion rate: 0% Randomised (N): 60 (20 intervention; 20, 20 comparison) |
|
| Participants |
Disorder: Generalised Anxiety Disorder; ADIS (DSM‐III R) Duration (years): 7.6 Age (years): 41.1 Sex (female): 54.35% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: Current and previous therapy restricted Medication: N/A Drug/Alcohol: "alcohol or substance misuse" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐list, Psychoeducation Comparison description: 1) Wait‐list. 2) "The IOP comprised two booklets of 27 pages total length containing general information, about the causes and consequences of anxiety, including the common symptoms of anxiety, Lazarus and Folkman’s (l984) model of stress and Cannon’s (l929) Fight‐Flight survival mechanism." Intervention name: Not named Days of treatment: 91 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=1 (10 min) Contact description: The total assessment interview took up to 120 minutes. "Those in the treatment group were introduced to the intervention through a 10 minute presentation following assessment." Intervention description: “two booklets of 27 pages total length...common symptoms...plus six others, totalling 106 pages and an audio cassette detailing relaxation exercises.” "detect internal and external anxiety cues and to learn to apply new coping strategies...self‐monitoring of thoughts, feelings and behaviours (Durham and Turvey, l987), cognitive change (Beck and Emery, 1985)..." Compliance: Author asked about use of material and strategies implemented in addition to amount read and frequency of reading. Measures of advice implemented are compared between groups. |
|
| Outcomes |
Specific Symptoms: Penn State Worry Questionnaire (PSWQ) General Symptoms: Beck Anxiety Inventory (BAI); Hospital Anxiety and Depression Scale (HADS): Anxiety Depression: Hospital Anxiety and Depression Scale (HADS): Depression |
|
| Notes |
Funding: "part of my post in an NHS psychology service" (personal communication) Unpublished data: Kiely provided unpublished papers with study details, demographics, outcome data. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Other “with reference to a prepared list of 60 spaces, numbered 1‐60 consecutively, each number being allocated in advance to one of the 3 conditions via a random number table.” |
| Allocation concealment (selection bias) | Low risk | “The assessor only referred to the randomised list once a patient was allocated to the next available space on the main list –hence they were unaware of the relevant condition in advance of allocation.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Those receiving the IOP or FP were introduced to the respective programmes by the assessor using a scripted presentation lasting up to 10 minutes.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=4 (20%) Comparison (wait‐list): N=6 (30%) Comparison (psychoeducation): N=4 (20%) Method of analysis: Available Case “independent Clinical Psychologist...blind to treatment condition and patient’s scores...read the initial assessments on each patient, including the ADIS‐R interview and their biographical self‐completion questionnaire. They then assigned a diagnosis, primary and secondary, to each patient. If the independent assessor decided a patient did not meet the criteria for the study, the patient’s results were excluded from the subsequent analysis. 12 were excluded on this basis. 2 failed to attend follow‐up. Participants with complete pre‐ and post‐treatment data were included in the analyses.” |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Unclear risk | “12 patients included (and randomised) were then excluded from analyses because didn't have primary diagnosis of GAD ‐ and unclear how many in each group.” |
Kiropoulos 2008.
| Methods |
Location: Victoria, Australia Recruitment: Advertising/ Internet Exclusion rate: 89.24% Randomised (N): 86 (46 intervention; 40 comparison) |
|
| Participants |
Disorder: Panic disorder; ADIS (DSM‐IV) Duration (years): Unknown Age (years): 38.96 Sex (female): 72.09% Race (white): 48.24% Medication (using at baseline): 48.24% Education (years): 12.53 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "Those participants who were taking medication for anxiety or depression were accepted if they had been stabilised on their medication for at least 12 weeks but continued to experience panic symptoms and met a diagnosis of PD." Drug/Alcohol: "alcohol or drug dependency" Physical: "heart condition…chronic hypertension" |
|
| Interventions |
Comparison group(s): Individual CBT Comparison description: “Participants attended one hour weekly treatment sessions with their allocated psychologist…given a copy of the manual ‘Mastery of Your Anxiety and Panic – Third Edition’ (Barlow & Craske, 2000)…focuses on teaching participants a variety of cognitive and behavioral strategies that include controlled breathing, cognitive restructuring, and interoceptive and situational exposure …weekly reading and were instructed to work through this manual with the assistance of the treating psychologist.” Intervention name: Panic Online (Klein and Richards) Days of treatment: 84 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email & Phone Automated contact: N=0 Provider contact: N=18.6 (352min) Contact description: See Table 4. Participants received 10.64 emails and sent 18.24. Therapists made .36 phone calls per participant. Author estimated assessment lasted 60 to 90 min (personal communication). “All psychologists interacted with their participant via email, which allowed the psychologist to provide individualized support and feedback to the participant, according to the participants’ individual needs…maintained a log of the time they spent…” Intervention description: “introductory module, four learning modules, and a relapse prevention module… instructions for controlled breathing, cognitive restructuring, and interoceptive and situational exposure...participants had access to the stress and benzodiazepine reduction modules…did not vary according to participant input. Participants were instructed to read one specified module per week and to practice the described activities in this module.” Compliance: “Participants in the face‐to‐face CBT treatment group completed a mean 10.96 sessions of the 12‐week treatment program. Unfortunately, no data is available about how many modules the PO participants completed.” "Therapists treating participants in the face‐to‐face CBT rated their participants as having higher compliance to treatment and having greater understanding of the treatment material given to them compared to the PO participants." |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ) General Symptoms: Anxiety Sensitivity Index (ASI); Depression, Anxiety, Stress Scales (DASS): Anxiety Response: Panic Free Recovery: High End‐State Functioning Depression: Depression, Anxiety, Stress Scales (DASS): Depression Quality of Life: WHO Quality of Life ‐ BREF |
|
| Notes |
Funding: National Health and Medical Research Council. Panic Online developed by Jeffrey Richards with funds from the Australian Rotary Health Research Fund. Unpublished data: Kiropoulos confirmed contact, duration of follow‐up, was aware of the allocation sequence. Further baseline measures not recorded, unable to reconcile discrepancy between education in text (p. 1275) and Table 1. Unable to provide weekly panic attacks or to recall assignment of 22 missing cases. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Other “After all pre‐assessment questionnaires were completed by the participants, they were randomly allocated using a random numbers table to either the PO or face‐to‐face CBT treatment condition.” |
| Allocation concealment (selection bias) | Low risk | All assessors were blind to treatment allocation of eligible participants into the study. "I had access and knowledge of the sequence table only. The manager of the project (me) allocated participants into the groups based on the random numbers table." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “All psychologists interacted with their participant via email” |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) “Additionally the ADIS‐IV was also conducted during a face‐to‐face interview by the assessor. Clinicians providing treatment to participants also completed the TAQ at post‐assessment for each participant they were allocated.” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: LOCF “Data analysis involved intention‐to‐treat analyses. Participants who had missing post‐assessment questionnaire(s) (n=22) or who discontinued treatment (n = 7) were treated as 'intention to treat’ (ITT). That is, participants’ pre‐assessment scores were carried forward and used in post treatment. 5 intervention and 2 controls discontinued treatment. 22 had missing post‐assessment questionnaires.” |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Unclear risk | N/A |
Klein 2001.
| Methods |
Location: Melbourne or Victoria, Australia Recruitment: Advertising/ Internet Exclusion rate: Unknown Randomised (N): 23 (11 intervention; 12 comparison) |
|
| Participants |
Disorder: Panic disorder; ADIS (DSM‐IV) Duration (years): Unknown Age (years): 40.82 Sex (female): 86.36% Race (white): 40.91% Medication (using at baseline): 40.91% Education (years): 11.7 EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: "Nine participants (41%) reported the use of anxiety medication but subsequently all reported no alteration in their dosage levels throughout the 3 weeks." Drug/Alcohol: Measured by the Prime MD Physical: "absence of any significant physical health problems" |
|
| Interventions |
Comparison group(s): Wait‐List Comparison description: Self‐monitoring only Intervention name: Panic Online (Klein and Richards) Days of treatment: 21 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Phone Automated contact: N=0 Provider contact: Unknown Contact description: Provided assistance loading programme. Random telephone checks conducted to ensure compliance. Average length of calls was 5 minutes and is included in the time reported for assessment. Assessment took 2.5 to 3 hours (personal communication) and the lower estimate was extracted. Intervention description: 2 x 45‐min sessions: "nature, effects and causes of panic, and the second on useful and non‐useful ways of managing panic. Negative self‐ statements were discussed as were errors in thinking. Brief techniques on how to overcome these cognitive errors were explained...considerable use of colour, animated illustrations, hyperlinks between sections of the text, and self‐ assessment quizzes with immediate feedback." Compliance: None reported, though the study indicates that information about progress was obtained from participants. |
|
| Outcomes |
Specific Symptoms: Body Vigilance Scale (BVS) General Symptoms: Anxiety Sensitivity Index (ASI) |
|
| Notes |
Funding: None acknowledged Unpublished data: Klein provided unpublished outcome data and details of contact with participants. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “Participants were randomly assigned…” |
| Allocation concealment (selection bias) | Unclear risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Random telephone checks conducted to ensure compliance” (personal communication) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=1 (9.09%) Comparison: N=0 (0%) Method of analysis: Available Case “One participant failed to complete the study and subsequently her data were excluded.” |
| Selective reporting (reporting bias) | Low risk | No trial registration number given. Full outcome data were provided by the author. |
| Other bias | Low risk | N/A |
Klein 2006.
| Methods |
Location: Australia Recruitment: Advertising/ Internet Exclusion rate: 57.69% Randomised (N): 55 (37 intervention; 18 comparison) |
|
| Participants |
Disorder: Panic disorder; ADIS (DSM‐IV) Duration (years): Unknown Age (years): Unknown Sex (female): 80% Race (white): 52.73% Medication (using at baseline): 52.73% Education (years): 12.5 EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: "Those participants who were taking medication for anxiety or depression were accepted if they had been stabilised on their medication for at least 4 weeks but continued to experience panic symptoms and met a diagnosis of PD." Drug/Alcohol: "alcohol or drug dependency" Physical: "stroke...heart condition...or chronic hypertension" |
|
| Interventions |
Comparison group(s): Attention/Monitoring Comparison description: participated in the same telephone and online assessments as those in the PO and MAN conditions...contacted the IC participants each week and inquired about their current panic status. She provided minimal support (e.g., empathic listening) and asked participants whether they had been doing their daily monitoring and advised them to re‐read the information on an internet‐based informational program... Intervention name: Panic Online (Klein and Richards) Days of treatment: 54 Author wrote: Yes Type of media: Mixed Type of therapy: CBT Location used: Anywhere Type of contact: Email & Phone Automated contact: N=0 Provider contact: N=12.45 (292.85min) Contact description: Internet: "Therapist interaction occurred via email, enabling the therapist to provide individualised support and feedback to the participant, according to their requests and needs." Mean 16.39 emails sent. Book: "informed that a therapist would telephone them at home once weekly to assist them and monitor their progress...The therapist was required to keep a log of amount of time spent..." Mean 7.73 calls. Intervention description: Two groups combined 1) "6‐week structured program comprised of an introductory module, four learning modules, and a relapse prevention module...controlled breathing, cognitive restructuring, and interoceptive and situational exposure." "did not vary according to participant input." 2) "MAP‐3 (Barlow & Craske, 2000) free of charge...cognitive and behavioural strategies that include controlled breathing, cognitive restructuring, and interoceptive and situational exposure as in PO." Compliance: Participants reported using the program mostly from home and rarely at their workplaces." |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ) General Symptoms: Anxiety Sensitivity Profile (ASP); Depression, Anxiety, Stress Scales (DASS): Anxiety Recovery: High End‐State Functioning Depression: Depression, Anxiety, Stress Scales (DASS): Depression |
|
| Notes | Funding: Australian Rotary Health Research Fund | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk |
Method: Other After assessment, all participants were randomly assigned sequentially (i.e., ABC, ABC) using a block design to internet‐based treatment, treatment with a self‐help manual with limited therapist assistance, or an internet‐based information control (IC) condition. |
| Allocation concealment (selection bias) | Low risk | The assessors were blind to which treatment the participant would be assigned to until after the pre‐assessment was completed. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) ...enabling the therapist to provide individualised support and feedback to the participant, according to their requests and needs |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “The clinician who conducted the post‐ and follow‐up assessments did not provide the treatment.” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: LOCF Data analysis involved intention‐to‐treat analyses. That is, for those participants who discontinued their involvement during treatment (n= 9), their pre‐assessment scores were carried forward and used in both the post‐treatment (PO, MAN, and IC) and follow‐up assessments (PO and MAN). |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Koszycki 2011.
| Methods |
Location: Canada Recruitment: Advertising and referral Exclusion rate: 13.1% Randomised (N): 251 (126 intervention; 125 comparison) |
|
| Participants |
Disorder: Panic disorder; SCID (DSM‐IV) Duration (years): 9.83 Age (years): 36.15 Sex (female): 40.3% Race (white): 0% Medication (using at baseline): 0% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current and previous therapy restricted Medication: "use of any psychotropics within 14 days of the baseline visit (6 weeks for fluoxetine)" Drug/Alcohol: Other primary comorbid disorder like generalized anxiety disorder, social phobia, somatization disorder and specific phobia. Other psychiatric disorders; electroconvulsive therapy in the past 6 months; if on Oxazepam, a maximum daily dose of 15 mg, 60 mg Physical: "a history of psychosurgery; significant medical conditions; abnormal laboratory findings; a hypersensitivity to serotonergic agents; a history of non‐response to sertraline; lactose intolerance" |
|
| Interventions |
Comparison group(s): Sertraline only, Placebo Only Intervention name: Not named Days of treatment: 84 Author wrote: Yes Type of media: Audio Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=8 (duration unknown) Contact description: Tapes were distributed weekly during acute treatment by a research coordinator and a standard format was adopted for instructions to be given to patients. Compliance was assessed at each visit by asking patients how much time they spent listening to the tape, whether they attempted the suggested homework and whether they recorded their homework in the workbook. Patients who entered the 12‐week extension phase were given the CBT package to use at their own discretion and no particular instructions were given. Intervention description: SCBT+ Sertraline and SCBT +Placebo "SCBT consisted of 12 audiotapes and a workbook that contained monitoring forms for homework. The tapes and workbook were developed for this study by psychologists with expertise in CBT. psychoeducation about anxiety and the cognitive model of PD, breathing retraining and relaxation skills, cognitive restructuring that addressed misappraisal of panic symptoms, interoceptive and situational exposure, and relapse prevention." Compliance: "Compliance was assessed at each visit by asking patients how much time they spent listening to the tape, whether they attempted the suggested homework and whether they recorded their homework in the workbook." |
|
| Outcomes | None included. | |
| Notes | Funding: Canadian Institutes of Health Research (POP‐15247) and Pfizer Canada. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online "Patients were randomly allocated to one of four groups by a computer generated randomization code" |
| Allocation concealment (selection bias) | Low risk | "Investigators at each site were provided with a sealed envelope that contained the identification of the study drug being administered to the patient. In a medical emergency, the investigator was authorized to break the code for that subject only." |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk |
Provider contact: Yes Provider blind: Yes Placebo and sertraline were provided as matching capsules and administered double‐blind. "Patients were instructed not to divulge their SCBT assignment to the investigators." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) "Outcome assessments were made by investigators who were blind to allocation of the drug and who were not told whether the patient was assigned to SCBT. Patients were instructed not to divulge their SCBT assignment to the investigators." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=3 (2.38%) Comparison: N=1 (0.80%) Method of analysis: Available Case "The mixed models were estimated by means of Restricted Maximum Likelihood (REML), and degrees of freedom were computed using the Kenward–Roger approach (Littell et al. 2006)." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Lewis 1978.
| Methods |
Location: Eugene (Oregon), USA Recruitment: College only Exclusion rate: 19.74% Randomised (N): 62 (50 intervention; 12 comparison) |
|
| Participants |
Disorder: Mixed (not specified); No diagnostic interview (questionnaire only) Duration (years): 4.9 Age (years): 23.88 Sex (female): 62.3% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Attention/Monitoring Comparison description: Subjects in this condition were asked to continue monitoring their daily anxiety experiences for an additional 2 weeks. In addition, they were reminded that there is evidence that self‐monitoring helps some people change their behavior. Intervention name: Don't be afraid: A self‐instructional program for reducing fears and phobia (Rosen, 1975) Days of treatment: 21 Author wrote: No Type of media: Book / Booklet Type of therapy: Muscle Relaxation Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=1 (40min) Contact description: Phone call, then "During the first appointment the study was described...subjects filled out all pretreatment assessment instruments, were assisted in identifying situations that made them anxious (Situations A and B), and were given instructions on self‐monitoring their anxiety. After 1 week of self‐monitoring, subjects returned to the clinic and met with the experimenter..." "contact with the subject over all three sessions was typically 1 hour and 40 minutes. The bulk of this time (approximately 60 minutes) was spent in subject's completing the relevant questionnaires." Intervention description: 1) "manual on deep muscle relaxation, which was written by Rosen (1975, 1976)...The manual suggested that the client practice each day in two 15‐ to 20‐minute sessions". 2) Pamphlet suggesting 15‐ to 20‐min daily using any method in anxiety provoking situations. Half of the participants in each group "were asked to deposit an amount of money that they "wouldn't want to lose." Compliance: Groups reported 12.75 to 17.64 mean practice sessions of 15.81 to 24.24 minutes over two weeks. Expectancy correlated with compliance, ease relaxing improvement on the STAI and on daily rating of tension. Adherence did not predict outcomes. Several clients said the manual was unclear and difficult to follow and some practice sessions would have helped. |
|
| Outcomes | General Symptoms: State‐Trait Anxiety Inventory (STAI): State | |
| Notes |
Funding: National Institute of Mental Health. Grant MH27559‐01. Unpublished data: Unable to locate Lewis. Biglan had no further information. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear Following a week of self‐monitoring, subjects were randomly assigned to one of five conditions. Assignments were done separately for men and women in order to equate the proportion of men and women in each condition. |
| Allocation concealment (selection bias) | Unclear risk | Randomisation followed assessment and a week of self‐monitoring. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) All participants were treated by the same person, who was aware of assignment. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=8 (16%) Comparison: N=2 (16.67%) Method of analysis: Unclear 10 dropouts. Assumed participants were randomised in equal numbers and assumed equal dropout between groups. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Several outcome measures are not reported: Ability to relax, Sense of self‐control, Benefit derived from programme, Likelihood they would use the techniques, Internal locus of control, How easy it was to get relaxed during sessions. |
| Other bias | Unclear risk | N/A |
Lidren 1994.
| Methods |
Location: Washington and Idaho, USA Recruitment: Advertising and referral Exclusion rate: 76% Randomised (N): 36 (12 intervention; 12, 12 comparison) |
|
| Participants |
Disorder: Panic disorder; ADIS (DSM‐III R) Duration (years): 6.23 Age (years): 34.85 Sex (female): 69.44% Race (white): 38.89% Medication (using at baseline): 38.89% Education (years): 14.1 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "subjects taking medication for anxiety were allowed to participants in the study if they still suffered from panic symptoms after at least six weeks of stabilization of their medication; if they maintained the same dosages throughout treatment; and if the recorded daily both type and amount of medication usage" Drug/Alcohol: "...chronic use of alcohol, drug dependence or abuse…" Physical: "Before the initiation of the study, a complete physical by a physician was required to rule out any organic cause for panic symptoms and/or complicating physical ailments. Researchers excluded: seizure disorders, kidney disease, stroke…emphysema, heart" |
|
| Interventions |
Comparison group(s): Wait‐list, Individual CBT Comparison description: 1) Wait‐list; 2) "met once a week for eight weeks for an hour and a half each session. All sessions were conducted by the same advanced clinical graduate student...Each participant in this condition was also responsible for reading the entire book Coping with Panic." Intervention name: Coping with Panic: A Drug‐Free Approach to Dealing with Anxiety Attacks (G Clum; 1990) Days of treatment: 56 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Phone Automated contact: N=0 Provider contact: N=3 (75 min) Contact description: Three calls lasting 25 minutes each following written protocol and did not answer questions or discuss treatment. Quizzed about the chapters in the book. (personal communication) Intervention description: responsible for reading the entire book, Coping with Panic, and mailing in weekly homework assignments…cognitive restructuring, breathing retraining, and exposure as well as advise individuals how to implement these strategies...exploring faulty cognitions, reattributing, seeking alternatives, decatastrophizing symptoms, and testing faulty hypothesis. Subjects purchased the book for $15 from the bookstore and paid $30 (half was refunded upon completion of the study). Compliance: Compliance measured through telephone interviews, diary and questionnaire. Intervention group practiced 2.8 (4.1) hours per week, group therapy participants practiced 3.6 (3.7). All participants in the intervention group got 70% or more of the answers correct at each of the three calling periods. |
|
| Outcomes |
Specific Symptoms: Mobility Inventory for Agoraphobia (MIA) Response: Panic Attacks: Frequency Depression: Beck Depression Inventory (BDI) |
|
| Notes |
Funding: None acknowledged Unpublished data: Watkins provided information about contact with participants and confirmed that assessment was not blind and there was no attrition. No further information was available from the authors. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Individuals who meta criteria for PD and agreed to participate in the study were randomly assigned to one of three conditions…"" |
| Allocation concealment (selection bias) | Unclear risk | See "Sequence Generation." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Interacted with researcher/clinician throughout the trial, who was not blind (Personal communication). |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: No dropout |
| Selective reporting (reporting bias) | Unclear risk | Main outcomes reported clearly in published study, but unable to extract data about medication usage. |
| Other bias | Low risk | N/A |
Marks 2004.
| Methods |
Location: London, England Recruitment: Advertising and referral Exclusion rate: 27.91% Randomised (N): 93 (37 intervention; 17, 39 comparison) |
|
| Participants |
Disorder: Mixed (AG, PD, SAD, SP); Clinical Interview (DSM‐IV) Duration (years): 17.13 Age (years): 38.3 Sex (female): 68.89% Race (white): 22.22% Medication (using at baseline): 22.22% Education (years): 11.24 EXCLUSIONS Depression: Yes Psychotherapy: No restrictions reported Medication: "not on a benzodiazepine or a diazepam‐equivalent dose of >5 mg/day…had not begun or changed dose or type of anti‐depressant medication within the last 4 weeks." Drug/Alcohol: "not on >21 units (men) or >14 units (women) of alcohol a week" Physical: "disabling cardiac or respiratory disease" |
|
| Interventions |
Comparison group(s): Relaxation, Individual Exposure Comparison description: 1) "guided in self‐relaxation techniques by a computer which explained the relaxation rationale, taught the practice of relaxation exercises with a biofeedback relaxation‐training program (de‐STRESS, 1997) and advised daily relaxation homework for 40 min daily between sessions. To facilitate homework, patients were given relaxation audio‐tapes." 2) "similar self‐exposure instruction, but guided entirely face‐to‐face by a clinician". Intervention name: Fear Fighter (Marks 2004) Days of treatment: 70 Author wrote: Yes Type of media: Computer Type of therapy: Exposure Location used: Clinic/ Surgery Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=6 (76min) Contact description: They were screened in a 25‐min semi‐structured interview to confirm a phobia/ panic diagnosis via a checklist of relevant DSM‐IV criteria. "each hour‐long session also included brief face‐to‐face help from a clinician : a mean of up to 5 min coaching and reviewing progress beforehand and up to 15 min discussing progress and giving extra treatment advice at the end." Mean therapist time 76 (43) minutes during treatment, 17 (5.4) during 1‐month follow‐up. Intervention description: six hour‐long individual treatment sessions "…self‐exposure therapy. Step 3 explained how to recruit and work with a co‐therapist. Step 4 helped clients identify the triggers…identify and set individualized exposure homework...coping tactics to remain in panic‐evoking situations. Step 7 gave clients coping exercises to practise during exposure. Step 8 reviewed exposure homework, gave feedback and helped users extend gains…Step 9 involved troubleshooting…" Compliance: [Relaxation] patients attended more treatment sessions than [face‐to‐face therapy] patients (R mean=5.7, SD=0.9; F mean=4.2, SD=2.2 ; Mann–Whitney U test= 186, Z=x2.26, P=0.008) and did more homework sessions than [face‐to‐face therapy] and [computerised] patients (R mean= 46, SD=24 ; F mean=20, SD=17 ; C mean= 24, SD=19; F(2,86)=11.02, P<0.001), but total homework time did not differ among F, C and R." |
|
| Outcomes |
Specific Symptoms: Fear Questionnaire (FQ): Global Phobia Disability: Work and Social Adjustment Scale (WSAS) |
|
| Notes |
Funding: EU Marie Curie Fellowship. Marks owns Fear Fighter. Unpublished data: Marks provided an unpublished manuscript. Mataix‐Cols provided unpublished follow‐up data. Unable to provide disaggregated data for different disorders. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online "... based on a computer‐generated set of random numbers. Suitable patients were randomized to one of three treatment groups in a 2F : 2C : 1R ratio…" |
| Allocation concealment (selection bias) | Low risk | "At the end of the screening interview the screening clinician obtained the patient’s randomization by asking the unit administrator to open the next opaque, sealed envelope from one of three sets (one per phobia type)…" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | “Patients had six hour‐long individual treatment sessions over 10 weeks and follow‐up 1 and 3 months later. The three therapists (two nurses and a psychiatrist) were experienced behaviour therapists. They standardized each treatment condition by using printed session‐by‐session guides." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) Assessors blindness was tested by asking them at post‐treatment to guess the treatment group of the patient. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=16 (43.24%) Comparison (Relaxation): N=1 (5.88%) Comparison (Individual Exposure): N=10 (25.64%) Method of analysis: Available Case “All analyses were intention‐to‐treat by analysing subjects in the group to which they were originally randomized (Everitt, 1994). Longitudinal data were analysed for all randomized patients for whom post‐baseline data were available. Where post‐baseline data were unavailable, baseline data were not carried forward in the manner often done...” “Two patients who had been randomized to F (one completer, one drop‐out) could not be included in the analysis as their files disappeared when the team moved to a new site on 28.9.00, as did data from one patient who was withdrawn on becoming severely depressed..." |
| Selective reporting (reporting bias) | Low risk | No trial registration number given. The author provided follow‐up data. "Many patients’ self‐ratings posted at follow‐up went astray when most of the team moved from the Maudsley to Charing Cross Hospital and staff changed." |
| Other bias | Low risk | N/A |
Matthews 2011.
| Methods |
Location: Hobart, Australia Recruitment: Advertising/ Internet Exclusion rate: Unknown Randomised (N): 26 (13 intervention; 13 comparison) |
|
| Participants |
Disorder: Specific Phobia; Clinical Interview (DSM‐IV) Duration (years): Unknown Age (years): 38 Sex (female): 100% Race (white): Unknown Medication (using at baseline): Unknown Education (years): 11.5 EXCLUSIONS Depression: Yes Psychotherapy: Current and previous therapy restricted Medication: N/A Drug/Alcohol: N/A Physical: "any serious medical condition" |
|
| Interventions |
Comparison group(s): Self‐help (Exposure) Comparison description: Intermittent exposure using feardrop.com. "“The intermittent stage involved exposure to the same fear‐relevant spider stimulus, alternating every 2 minutes with an irrelevant stimulus (beach ball), resulting in four 2‐minute fear‐relevant exposure trials and three 2‐minute fear‐irrelevant expo‐ sure trials.” Intervention name: feardrop.com Days of treatment: 1 Author wrote: Yes Type of media: Internet Type of therapy: Exposure Location used: Clinic/ Surgery Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=1 (duration unknown) Contact description: SUDS ratings were completed prior to exposure (0 minutes), at 2‐minute intervals during the task (2, 4, 6, 8, 10, and 12 minutes) and at completion of the task (14 minutes). Intervention description: Continuous exposure using feardrop.com. "exposure to an image of a fear‐relevant stimulus (Huntsman spider) for seven 2‐minute trials." “Photographs of huntsmen spiders were taken by the researchers and associates or were obtained from online sources with a creative commons licence…All home‐based stages were continuous. Each stage lasted 6 minutes. SUDS ratings were completed prior to each stage (0 minutes), during each stage (at 2 and 4 minutes), and at the end of each stage (6 minutes).” Compliance: Lab‐based. Measured "Time spent outside the tracking circle" |
|
| Outcomes | None included. | |
| Notes | Funding: None acknowledged | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear sequentially allocated to two exposure groups (intermittent exposure or continuous exposure) |
| Allocation concealment (selection bias) | Unclear risk | recruited following the screening interview and were sequentially allocated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) For both tasks SUDS ratings were completed prior to exposure (0 minutes), at 2‐minute intervals during the task (2, 4, 6, 8, 10, and 12 minutes) and at completion of the task (14 minutes). |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=2 (15.38%) Comparison (other): N=1 (7.69%) Method of analysis: Available Case The data for three participants were excluded due to technical issues with the program "Six participants did not complete the 1‐week post‐treatment assessment and the home‐based exposure task, and a further three participants did not complete the one‐month post treatment assessment. Thus full follow‐up data were available for 14 participants." "Outcome measures at all three assessment times were available for 14 participants." |
| Selective reporting (reporting bias) | High risk | No trial registration number given. "These data were not analysed by exposure group, due to small numbers in the intermittent (n = 6) and continuous (n = 8) groups." |
| Other bias | Low risk | N/A |
Maunder 2009.
| Methods |
Location: Northumberland, England Recruitment: Prison Exclusion rate: 43.902439024% Randomised (N): 38 (20 intervention; 18 comparison) |
|
| Participants |
Disorder: Mixed, but d ue to the small number of participants recruited with depression, only results from the anxiety group were analysed ; No diagnostic interview (questionnaire only) Duration (years): Unknown Age (years): 35.22 Sex (female): 0% Race (white): Unknown Medication (using at baseline): Unknown Education (years): 11.53 EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: "During the study both groups also experienced treatment as usual from the primary health care teams and referral to the mental health in‐reach team as appropriate. This included medication, support, counselling, or other psychological therapies." Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Comparison description: "All received other mental health treatment as usual." Intervention name: Not named Days of treatment: 28 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: there was little trouble with literacy during the study, though occasional help was needed. "It is also unclear whether there would have been added benefit from guidance on the self‐help materials from a health or other worker. About half of the participants in the study indicated that this might have been useful." Intervention description: They are based on the Northumberland, Tyne and Wear NHS Trust booklets, and use CBT principles. “The materials had been redrafted and re‐designed, with the aid of prisoners, to make them suitable for this population (Maunder et al., 2004).” Compliance: N/A |
|
| Outcomes | General Symptoms: Hospital Anxiety and Depression Scale (HADS): Anxiety | |
| Notes |
Funding: The study was supported by a small research grant from Northumberland Care Trust. Depression groups excluded from this review |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “Blocked randomization using computer‐generated number sequences was used to allocate participants to the intervention (group B) or control (group A) in both the anxiety and depression groups.” |
| Allocation concealment (selection bias) | Low risk | "The researcher, blind to the allocation of groups, administered the HADS and BSI" "participants assigned to the intervention group received the self‐help booklet for anxiety or depression in an opaque envelope (for privacy and for the purpose of randomisation)." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “there was little trouble with literacy during the study, though occasional help was needed." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “The study was a pilot single‐blind randomized controlled trial (RCT)." “The researcher, blind to the allocation of groups, administered the HADS and BSI " "'The post‐intervention evaluative questionnaire (conducted in the form of a semi‐structured interview) was completed with the intervention group at the second assessment and the control group at the third assessment." |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=5 (25%) Comparison: N=0 (0%) Method of analysis: Available Case “As a result of DNA’s, withdrawals, discharges and transfers only 82.6% completed the second assessment and 71.7% completed the third assessment." |
| Selective reporting (reporting bias) | Unclear risk |
Trial registration number: ISRCTN54760645 Results for the BSI are not reported in full. Results for the depression group are not reported at all, but these would not have been included in this review. Trial registration only lists the primary outcome (HADS). |
| Other bias | Low risk | N/A |
McNamee 1989.
| Methods |
Location: London, England Recruitment: Advertising/ Internet Exclusion rate: 37.84% Randomised (N): 23 (13 intervention; 10 comparison) |
|
| Participants |
Disorder: Panic disorder w/ AG; SCID (DSM III) Duration (years): 12 Age (years): 45 Sex (female): 88.89% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: Current and previous therapy restricted Medication: "no more than 10mg diazepam or its equivalent" Drug/Alcohol: "...no more than 2 pints of beer daily." Physical: "no serious cardiac or pulmonary disease" |
|
| Interventions |
Comparison group(s): Applied relaxation (self‐help) Comparison description: “relaxation tapes and had the same format of telephone consultations over 12 weeks. The rationale given to them was: ‘You become anxious and panicky in feared situations and so avoid them. Over the next 12 weeks we will teach you how to relax so that you may overcome your phobia.’...If control subjects asked whether to enter phobic situations they were told: ‘It is entirely up to you to do whatever you feel comfortable with.’” Intervention name: Living With Fear (Marks, 1980) Days of treatment: 84 Author wrote: Yes Type of media: Book / Booklet Type of therapy: Exposure Location used: Anywhere Type of contact: Phone Automated contact: N=0 Provider contact: N=10 (120 min) Contact description: "They spoke on the phone with a therapist for 12 mins weekly for 8 weeks and then 2‐weekly for a further 4 weeks i.e. for 10 times in all for a total of 2 hours over 12 weeks. During telephone contact new goals were set each week." "Total time spent in telephone contact did not differ in the 2 groups." Intervention description: “posted to them a self‐help manual (Living with Fear, Marks 1978) with the rationale: Only by facing the situations that evoke fear and enduring the ensuing discomfort until it subsides will you overcome your problem...They were encouraged to have feelings of discomfort...breathing control and positive self‐statements." Compliance: 46% intervention and 80% controls completed 12 week treatment. "Subjects were asked to practice self‐exposure of these goals at least 4 times a week for 2 hours at a time, and to record these self‐exposure activities in homework diaries." |
|
| Outcomes |
Specific Symptoms: Fear Questionnaire (FQ): Global Phobia, assessor rated Response: Target Phobias Disability: Work and Adjustment Rating Scale (WARS), assessor rated |
|
| Notes |
Funding: Upjohn Company Unpublished data: Requested further information. Lelliott replied that data may be lost. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “Of these, 23 agreed to self‐treatment guided by phone and were randomized…” |
| Allocation concealment (selection bias) | Unclear risk | “Evaluation at baseline was by a blind evaluator...” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “One therapist (GM) gave the telephoned guidance to both exposure and control groups throughout the study.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “further telephoned blind evaluations were done at weeks 2,4,6,8,10,12,20 and 32.” |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=7 (53.85%) Comparison: N=2 (20%) Method of analysis: Available Case “Before week six, 5 patients dropped out leaving no data for outcome analysis (4e, 1r). At week six, 18 cases were evaluated (9e, 9r). Thereafter, 4 ceased contact (3e ‐ 1 had too many panics, 1 became depressed and needed antidepressants, 1 died; 1r ‐ was 'fed up'). The 14 patients (6e, 8r) were assessed at week 32 i.e. follow‐up at 5 months posttreatment. One exposure case at week 6 developed complications of pregnancy precluding her doing exposure homework, but was retained in the analysis. The 18 evaluable subjects…” |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Self‐ratings were of the Fear Questionnaire (Marks & Mathews 1979), 4 phobic targets (each 0‐8), social adjustment (as above), Beck Depression Inventory (21‐item). Homework, phobic outings and panics were recorded in weekly diaries which patients were asked to return by post fortnightly. "Assessor ratings were used in the analysis as subjects had not consistently returned self‐ratings." |
| Other bias | Low risk | N/A |
Mead 2005.
| Methods |
Location: North West, England Recruitment: Referral Exclusion rate: 81.81% Randomised (N): 114 (57 intervention; 57 comparison) |
|
| Participants |
Disorder: Mixed ( presenting complaint for 69% o f participants was an anxiety disorder or mixed anxiety w ith depression ; 51% anxiety alone); No diagnostic interview (questionnaire and GP report) Duration (years): Unknown Age (years): 39.75 Sex (female): 67.54% Race (white): 66.5% Medication (using at baseline): 66.5% Education (years): 13.52 EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: "current involvement with other statutory specialist mental health services (e.g. substance abuse)" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Comparison description: The WLC group involved routine care from primary‐care professionals, which may involve general support, antidepressant medication or referral to community agencies. Intervention name: Self‐Help in Anxiety and Depression: SHADE (Richards and Lovell). Days of treatment: 91 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=3.16 (101.12min) Contact description: 50 (88%) attended at least one session, and 31 (54%) attended all four. The mean number of sessions attended was 3.16 (SD=1.94) and the mean session length was 32 minutes (SD=6.3). Intervention description: “...information about anxiety and depression and available interventions...descriptions of patients’ experiences, derived from focus groups with service users, who were also involved in evaluating the draft manual. Part two was a therapeutic section based on cognitive‐behavioural principles and containing specific exercises: behavioural activation, exposure, problem solving, cognitive restructuring and lifestyle strategies, with case vignettes and details of how to apply the interventions.” Compliance: “88% reported reading ‘at least half the manual’, although only 52% reported conducting self‐help exercises ‘at least weekly’.” |
|
| Outcomes |
General Symptoms: Hospital Anxiety and Depression Scale (HADS) Depression: Beck Depression Inventory (BDI) Disability: Social Adjustment Scale (SAS) |
|
| Notes |
Funding: National Primary Care Research and Development Centre, University of Manchester (funded by the Department of Health). Authors publish similar manuals commercially. Unpublished data: Mead provided unpublished outcome data, details of assessment, duration of intervention, and contact details. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “Allocation to treatment was undertaken using a dynamic form of random allocation called minimization conducted by an external specialist clinical trials unit...minimized by BDI score (0–22, or 23+), estimated time remaining to first formal therapy appointment (3–5 months, 6–8 months, or 9 months or over) and type of therapy for which patients had been referred (CBT/psycho‐dynamic therapy or counselling).” |
| Allocation concealment (selection bias) | Low risk | “Allocation was thus effectively concealed from the researchers making judgements of eligibility…” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “GSH intervention involved…one‐to‐one sessions with an AP” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=7 (12.28%) Comparison: N=4 (7.018%) Method of analysis: Available Case “Data missing because of loss to follow‐up were not imputed, but stepwise logistic regression (with backward selection) was used initially to investigate predictors of loss to follow‐up.” |
| Selective reporting (reporting bias) | Low risk |
Trial registration number: ISRCTN33308608 All outcomes reported. |
| Other bias | Low risk | N/A |
Milne 1988.
| Methods |
Location: Wakefield, England Recruitment: Referral Exclusion rate: Unknown Randomised (N): 22 (8 intervention; 7 comparison) |
|
| Participants |
Disorder: Generalised Anxiety Disorder; Other Duration (years): Unknown Age (years): 53 Sex (female): 72.22% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Anxiety: How to understand and control your nerves (Milne and Linford, 1984) Days of treatment: 28 Author wrote: Yes Type of media: Book / Booklet Type of therapy: Muscle Relaxation Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: Both groups received treatment‐as‐usual by GP unaware of group assignment. Intervention description: “35 page account of anxiety in terms of the nervous system, its prevalence and causes, and ways of managing it by behaviour therapy. For example, it detailed how to practise progressive muscular relaxation. Self‐test quizzes were provided after each section of the manual so as to provide feedback on understanding. Diagrams and illustrations were included.” Compliance: Not collected. |
|
| Outcomes |
General Symptoms: Fear Questionnaire (FQ): Total Phobia |
|
| Notes |
Funding: None acknowledged Unpublished data: Milne was unable to provide further information but suggested how randomisation may have been done and what race participants might have been. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “The 22 referrals were randomly allocated to one of three groups…” The author cannot recall but suggests it may have been names in a hat (personal communication). |
| Allocation concealment (selection bias) | Low risk | “The referring GP was unaware of group assignment.” |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk |
Provider contact: Yes Provider blind: Yes The referring GP was unaware of group assignment. "There was no concurrent modification of the routine GP management of the patient’s anxiety, for example, medication." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=1 (12.5%) Comparison: N=1 (14.29%) Method of analysis: Unclear “During the evaluation period, 22 patients with clinical anxiety were diagnosed and referred to the study by a GP All had agreed to participate in the study Four patients did not return their questionnaire, leaving a sample of 18." Dropout estimates assuming equal allocation of 22 participants. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Some outcomes not fully reported, including Coping and Change Questionnaire, consultations, and use of medication. |
| Other bias | Low risk | N/A |
Moritz 2010.
| Methods |
Location: Germany/ Switzerland Recruitment: Advertising/ Internet Exclusion rate: 37.23% Randomised (N): 86 (43 intervention; 43 comparison) |
|
| Participants |
Disorder: OCD; "participants confirmed that a diagnosis of OCD was previously determined..." Duration (years): Unknown Age (years): 34.52 Sex (female): 67.44% Race (white): Unknown Medication (using at baseline): Unknown Education (years): 11.6 EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: My metacongitive Training for OCD (myMCT) Days of treatment: 30 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: It was made clear that participation would not require personal or telephone contact and that it was strictly anonymous. "Patients were provided with the e‐mail address of the first author in case of questions. E‐mails were responded to within 24 hours. However, only three participants turned to the first author, whereby questions were solely related to the handling of the PDF file." Intervention description: “self‐help manual starts with an introduction which defines core features of OCD symptomatology, demonstrates its most prevalent subtypes and requests patients to identify their own core problems and dysfunctional coping strategies…then, the aims of the program are explicated. the myMCT consists of 14 sections dealing with prevalent cognitive biases in OCD” Compliance: “36 patients who received the manual, nine stated that they had not read the manual...” "half of the patients stated that they did not find the time to study the manual intensively. 25.9% performed exercises over a time‐span of at least 14 days, whereby only two patients (7.4%) performed the exercises every day. The largest group (55.5%) performed the exercises for 7 to 14 days. The rest (18.5%) spend less than seven days..." |
|
| Outcomes | None included. | |
| Notes | Funding: None acknowledged | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear Participants who left e‐mail addresses were allocated to the experimental or waitlist group according to a random plan. |
| Allocation concealment (selection bias) | Unclear risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | No contact with researchers or clinicians. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=7 (16.28%) Comparison: N=5 (11.63%) Method of analysis: Per protocol “…data from participants in the experimental group (myMCT) who after the third and final reminder still did not disclose whether or not they had read the manual were removed from the analyses...we retained patients in the myMCT group who had read (part of) the manual but did not perform any of the exercises according to self‐report." |
| Selective reporting (reporting bias) | High risk | No trial registration number given. T‐tests reported, but these cannot be analysed as it is unclear how many participants are in each group and if they were analysed in the groups to which they were assigned. |
| Other bias | High risk | “Unclear if methods used for the figures were used for all analyses: ‘Figures 1 and 2 show the results of the pre‐post assessment calculated for completers. For this analysis, we added subjects from the myMCT group who did not read the manual to the waitlist group.’” |
Muller 2011.
| Methods |
Location: Basel, Switzerland Recruitment: College only Exclusion rate: 83.64% Randomised (N): 36 (18 intervention; 18 comparison) |
|
| Participants |
Disorder: Specific Phobia; No diagnostic interview (questionnaire only) Duration (years): Unknown Age (years): 23.17 Sex (female): 100% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Attention/Monitoring Comparison description: “The spider‐fearful control participants underwent the same procedure with presentation of nine neutral pictures and an equal exposure time of 27 min.” Intervention name: Not named Days of treatment: 7 Author wrote: Yes Type of media: Internet Type of therapy: Exposure Location used: Clinic/ Surgery Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=1 (duration unknown) Contact description: “Participants were tested individually in a sound‐attenuated room.” Intervention description: “When participants had completed the pretreatment FSQ and BAT they were seated in front of a computer, 60 cm from the screen, to perform the CBE...All instructions were presented on the computer screen. Each spider picture in the CBE group was presented on the computer screen for 3 min, with a total standardised exposure time of 27 min.” Compliance: Lab‐based, but compliance data not reported. |
|
| Outcomes |
Specific Symptoms: Fear of Spider Questionnaire (FSQ) Behaviour Test (Level): Behavioural Approach Test: Level |
|
| Notes | Funding: None acknowledged | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “The experimenter randomly assigned participants meeting the inclusion criteria to the CBE condition (n=18) or the control condition (n=18).” |
| Allocation concealment (selection bias) | Unclear risk | “The experimenter randomly assigned participants meeting the inclusion criteria to the CBE condition (n=18) or the control condition (n=18).” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Participants were tested individually in a sound‐attenuated room.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: No Dropout |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Nordin 2010.
| Methods |
Location: Sweden Recruitment: Advertising/ Internet Exclusion rate: 80% Randomised (N): 40 (20 intervention; 20comparison) |
|
| Participants |
Disorder: Panic disorder; No diagnostic interview (questionnaire only) Duration (years): 10.1 Age (years): 37.7 Sex (female): 72.5% Race (white): 37.5% Medication (using at baseline): 37.5% Education (years): 13.1 EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: '"Participants taking medication were allowed to participate if the dose of medication was stable for 3 months prior to commencing the self‐help treatment. Participants in the treatment group were asked not to increase or decrease the dosage during the study without consulting their prescribing physician." Drug/Alcohol: N/A Physical: "any of the following somatic complaints: epilepsy, kidney problems, stroke, organic heart syndrome, emphysema, heart attack, or hypertension" |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Ingen panik: Fri från panik‐ och ångestattacker i 10 steg med kognitiv beteendeterapi. [No panic: Free from panic and anxiety] Days of treatment: 70 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: “In the written letter, the participants were also encouraged to contact the person responsible for the study if they had any further questions during the duration of the treatment. However, none of the participants did so.” Intervention description: “308 pages...psychoeducation...breathing retraining and a hyperventilation test. Chapters 4–5 contain information and exercises regarding cognitive restructuring, and chapters 6–7 give instructions on how to do interoceptive exposure. Chapters 8–9 deal with exposure in vivo, and the book ends with a chapter on relapse prevention and assertiveness training. At the end of each chapter, the reader is presented with a quiz...the reader was also given homework assignments...” Compliance: N/A |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ) General Symptoms: Beck Anxiety Inventory (BAI) Response: Panic Disorder Severity Scale (PDSS) Recovery: No longer met criteria for diagnosis Depression: Beck Depression Inventory (BDI); Montgomery and Asberg Depression Rating Scale (MADRS) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes | Funding: Swedish Research Council "Dr. Carlbring shares intellectual property rights in the tested book." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “used the www. random.org website to generate a list that was then sent to the researchers.” |
| Allocation concealment (selection bias) | Low risk | “Randomization was arranged by an independent person without contact with the participants.” |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | No contact with researchers or clinicians. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) “Along with the PDSS, the interviewer also formed a clinical global impression (CGI; Guy, 1976) of each participant at posttreatment and follow‐up. The interviewer was not uninformed regarding the treatment status" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: LOCF “Only one individual, belonging to the waiting list group, dropped out of the study. This participant failed to complete the online self‐ report instruments at posttreatment and was not reachable for the telephone interview. Intention‐to‐ treat analysis was used for this single case (Newell, 1992), with the last observation carried forward procedure assuming no change in scores." |
| Selective reporting (reporting bias) | High risk | No trial registration number given. “The mobility inventory…one version incorporating pictures (data not included here)" CGI data are not reported." |
| Other bias | Low risk | N/A |
Ost 1991.
| Methods |
Location: Oxford (UK) and Uppsala (Sweden) Recruitment: Advertising and referral Exclusion rate: 2.86% Randomised (N): 34 (17 intervention; 17 comparison) |
|
| Participants |
Disorder: Specific Phobia; ADIS (DSM‐III R) Duration (years): 25.2 Age (years): 31.5 Sex (female): 100% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: "have no heart or lung disease" |
|
| Interventions |
Comparison group(s): Individual Exposure Comparison description: “...detailed rationale for exposure, incorporating ideas of habituation, self‐control, and being able to control and predict the spider, and the patient's own reactions... Four or five spiders in increasing sizes were used during single therapy session that lasted a max of 3 hours. Each step was modeled by the therapist before the patient carried it out. Mean 126.2 (30.5) minutes. Sessions videotaped and replayed to patients. (Intervention strategies similar, method of delivery varied.)” Intervention name: Not named (also used in Hellstrom 1995) Days of treatment: 14 Author wrote: Yes Type of media: Book / Booklet Type of therapy: Exposure Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: “The interview took about 60 min, and its main purpose was to ascertain the patient's suitability for the study and to conduct the behavioral test." "At the end of the screening interview the patient had to agree to schedule at least two 2 hr. self‐exposure sessions during the next 2 weeks..." Intervention description: “had to agree to schedule at least two 2 hr. self‐exposure sessions during the next 2 weeks...get the help of a relative or friend to collect 4‐5 spiders...If getting this help was impossible, the patient was to call the experimenter who would give her the necessary spiders...30‐page manual...based on the procedures of the therapist‐directed one‐session treatment...same general information as that in Marks (1978)” Compliance: Mean number sessions 3.2 (1.9), range 0 to 6. One patient did not try the exposure due to anxiety. 16 participants completed a mean of 3.4 exposure sessions each. Mean exposure time was 282.8 minutes (157.5), range 0 to 535. Mean exposure time per session 80.4 (18.4) minutes. |
|
| Outcomes |
Specific Symptoms: Spider Phobia Questionnaire (SPQ) Behaviour Test (Symptoms): Behavioural Approach Test: Symptom Rating Response: Behavioural Approach Test: Completed; Clinically Significant Improvement (Composite) |
|
| Notes |
Funding: Swedish Medical Research Council. Medical Research Council (UK). Unpublished data: Ost provided unpublished outcome data and information about participant characteristics. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear At both sites the patients were randomly assigned to treatment conditions |
| Allocation concealment (selection bias) | Unclear risk | N/A |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "At the end of the screening interview the patient had to agree to schedule at least two 2 hr. self‐exposure sessions during the next 2 weeks, i.e. the interval between the pre‐ and post‐treatment assessment for the therapist‐directed group. It was emphasized that more would be preferred." |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) “The authors functioned as therapists” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No Dropout |
| Selective reporting (reporting bias) | Low risk | No trial registration number given. Several outcomes do not appear in the published report, but data were provided by the author. |
| Other bias | Low risk | N/A |
Paxling 2011.
| Methods |
Location: Linkoping, Sweden Recruitment: Advertising/ Internet Exclusion rate: 66.54% Randomised (N): 89 (44 intervention; 45 comparison) |
|
| Participants |
Disorder: Generalised Anxiety Disorder; SCID (DSM‐IV) Duration (years): 20 Age (years): 39.3 Sex (female): 79.78% Race (white): Unknown Medication (using at baseline): 37.1% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "Participants on medication (e.g. anti‐depressants) had to be stabilized for at least 1 month and were asked to maintain a stable dose level during the study " Drug/Alcohol: "An AUDIT score of 19 or higher has been reported to indicate severe alcohol problems and was chosen as a cutoff in this study." Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Not named Days of treatment: 56 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=8 (97 min) Contact description: "Feedback from the therapist was provided on a weekly basis in association with the homework assignments. This feedback usually ranged in length from one‐half written page to three written pages. In addition, occasional reminders were sent via e‐mail...therapist time devoted to each client ranged from 10 to 15 min per week, totalling 71 h and 5 min for all patients in the trial and a mean of 97 min (SD=52, range=12–215) per patient." Intervention description: "text‐based treatment modules delivered on a weekly basis for 8 weeks..psychoeducation...applied relaxation...applied relaxation and worry time...applied relaxation and cognitive restructuring...applied relaxation, more on cognitive distancing, and problem solving...applied relaxation and worry exposure...applied relaxation, interpersonal problem solving, and sleep management...relapse prevention...CD with audio‐recorded instructions..." Compliance: "The mean number of treatment modules completed was 4.8 (SD=2.1), and only 10.5% (4/38) completed all modules in time." |
|
| Outcomes |
Specific Symptoms: Generalized Anxiety Disorder Questionnaire–IV General Symptoms: Beck Anxiety Inventory (BAI); State‐Trait Anxiety Inventory (STAI) Response: Generalized Anxiety Disorder Questionnaire–IV; Penn State Worry Questionnaire (PSWQ) Depression: Beck Depression Inventory (BDI); Montgomery and Asberg Depression Rating Scale (MADRS) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes | Funding: Swedish Council for Working and Life Research | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/ Online "A computer‐generated random list was obtained via www.random.org, which utilizes atmospheric noise to create random sequences of numbers." |
| Allocation concealment (selection bias) | Low risk | "by an independent person not involved in the study" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "Feedback from the therapist was provided on a weekly basis in association with the homework assignments." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) "The interviewers were blinded concerning participant status" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=6 (13.64%) Comparison: N=1 (2.22%) Method of analysis: Mixed effects "To compare the Internet treatment and control group according to the outcome measures at baseline and posttreatment, an unstructured covariance pattern model was used. The restricted maximum likelihood model was used as estimation method." |
| Selective reporting (reporting bias) | High risk | CGI‐Improvement not reported. |
| Other bias | Low risk | N/A |
Proudfoot 2004a.
| Methods |
Location: London and SE England Recruitment: Referral Exclusion rate: 45.42% Randomised (N): 274 (146 intervention; 128 comparison) |
|
| Participants |
Disorder: Mixed ( presenting complaint for 66% was an anxi ety disorder or mixed anxiety and depression; 14% had anxiety alone); No diagnostic interview (questionnaire only) Duration (years): Unknown Age (years): 43.51 Sex (female): 73.72% Race (white): 68.39% Medication (using at baseline): 68.39% Education (years): 13.76 EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: "had been taking medication for anxiety and/or depression continuously for 6 months or more immediately prior to entry" "he general practitioner, who administered the inclusion and exclusion criteria, decided whether medication was to be prescribed, and indicated the treatment the patient was to receive if randomly allocated to treatment as usual" Drug/Alcohol: "patients were excluded if they had alcohol and/or drug dependence" Physical: N/A |
|
| Interventions |
Comparison group(s): Treatment‐as‐usual Comparison description: GPs could prescribe medication or refer to counselling. Usual care included discussions with the doctor, practical and social help, further physical investigation. Intervention name: Beating the Blues (Ultrasis; http://www. ultrasis.com) Days of treatment: 63 Author wrote: Yes Type of media: Computer Type of therapy: CBT Location used: Clinic/ Surgery Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=8 (80min) Contact description: Nurses were instructed to spend no more than 5 min with each patient at the start and at the end of each session (i.e. up to a total of 80 min over the eight sessions). Intervention description: interactive, multimedia, computerised cognitive–behavioural therapy package consisting of a 15min introductory videotape, followed by eight therapy sessions (Fig. 1). Each weekly session lasts about 50 min, with ‘homework’ projects between the sessions. Goal setting automatic thoughts, thinking errors, distraction, attributional styles, activity scheduling, problem solving, graded exposure, task breakdown. Compliance: Sessions attended reported for "Phase 1", which is a partial report. Data not found for Phase 2 or the full sample. |
|
| Outcomes | Anxiety was reduced only in participants with BAI scores over 18. General Symptoms: Beck Anxiety Inventory (BAI) Depression: Beck Depression Inventory (BDI) Disability: Work and Social Adjustment Scale (WSAS) |
|
| Notes |
Funding: NHS Executive London, Ultrasis (owner Beating the Blues). Authors declare financial conflict. Unpublished data: Proudfoot provided details about participants and conduct of the study. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Mechanical “Within each of the seven surgeries, patients who fitted the inclusion criteria and consented to participate were stratified according to whether they were prescribed medication or not (yes, no), and the duration of current episode of episode (f6 months, >6 months). They were then randomly allocated, within each of the two strata, to receive BtB or TAU.” |
| Allocation concealment (selection bias) | Low risk | “Randomly sorted cards naming one of the two treatments (computer therapy/treatment as usual) were placed by the first author in individual envelopes, which were sealed and numbered.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Nurses were instructed to spend no more than 5 min with each patient at the start and at the end of each session…" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=54 (36.99%) Comparison: N=35 (27.34%) Method of analysis: Available Case Means and SD do not appear to include imputed values. "All analyses were intention‐to‐treat, by which we mean that patients were analysed as randomised rather than by treatment actually received. Within each intention‐to‐treat group, patients were not included in the model‐fitting process described above if they had missing values on any of the covariates used (pre‐treatment value, drugs, duration of episode) or if all four post‐randomisation values of the response being analysed were missing. Consequently, all the available post‐randomisation values of the response were included, rather than only those obtained from patients with all four values recorded." |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Data about receipt of other treatments are reported for Phase 1, but not for Phase 2. Compliance data are also reported only for Phase 1. |
| Other bias | Low risk | N/A |
Rapee 2007.
| Methods |
Location: Sydney, Australia Recruitment: Advertising and referral Exclusion rate: Unknown Randomised (N): 224 (56 intervention; 52, 59 comparison) |
|
| Participants |
Disorder: Social Anxiety (General); ADIS (DSM‐IV) Duration (years): Unknown Age (years): 35.81 Sex (female): 51.5% Race (white): 31.74% Medication (using at baseline): 31.74% Education (years): 13.4 EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: "Concurrent pharmacotherapy or psychotherapy was allowed as long as dosages had been consistent for 3 months and there was no plan to change." Drug/Alcohol: "severe substance misuse or dependence" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List, Group CBT Comparison description: 1) Wait‐list. 2) "groups of approximately six participants with two graduate psychology student therapists…ten 2h sessions across 12 weeks. Treatment was manualised, based on principles and components described in a book by Rapee & Sanderson (1998)...cognitive restructuring of negative evaluation beliefs, exposure to feared social situations, realistic feedback of social performance, and attention training. Participants engaged in home exercises and received various handouts as relevant.” Intervention name: Overcoming Shyness and Social Phobia: A Step by Step Guide (Rapee, 1998) Days of treatment: 84 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: Participants in the pure self‐help group were given a copy of the book and the cover letter and were then simply contacted again after 12 weeks for a second assessment. Duration of assessment estimated (personal communication). Intervention description: “The strategies outlined paralleled those in the standard group treatment, and practice sheets and exercises formed part of the book…given a cover letter with the book welcoming them to the programme and providing a suggested rate of progress in order to complete it in 12 weeks.” Compliance: Pure self‐help read 4.11 (2.95) chapters. Those with more severe social phobia read more chapters, and they experienced the greatest improvement. However, improvement was not related to the group x time x chapters interaction: differences in the number of chapters read did not account for differences in improvement between groups. |
|
| Outcomes |
Specific Symptoms: Brief Fear of Negative Evaluation (BFNE) Recovery: No longer met criteria for diagnosis |
|
| Notes |
Funding: None acknowledged Unpublished data: Rapee provided study details and referred to Baillie, who was on sabbatical. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Unclear Those who met inclusion criteria were randomly allocated to one of the four conditions. Randomisation was done using a pre‐assigned random number generator in blocks of eight to allow for group delivery. |
| Allocation concealment (selection bias) | High risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "Standard treatment was included to represent the ‘gold standard’ treatment effect. Treatment was conducted in groups of approximately six participants with two graduate psychology student therapists who received minimal supervision from an experienced clinical psychologist." |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Included assessor‐rated outcomes (blinding unclear) "The number and percentage of participants from each treatment condition who no longer met criteria for a diagnosis of social phobia at the post‐treatment and follow‐up assessments are shown in Table 2." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison (wait‐list): N=0 (0%) Comparison (group CBT): N=0 (0%) Method of analysis: LOCF "The number of participants who provided no data at post‐treatment and at 3‐month follow‐up is shown in Fig. 1. The last value carried forward strategy was used to substitute missing data if data were not available at the 3‐month follow‐up or at both post‐treatment and 3‐month follow‐up. Interpolation was used if posttreatment data only were not available. As a precaution against biasing effects of these methods of handling missing data, analyses were conducted with and without missing data substituted. Analyses with missing data substituted are equivalent to intent‐to‐treat analyses" |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Outcomes are not reported for the Albany Panic and Phobia Questionnaire or the Self Consciousness Scale. |
| Other bias | Low risk | N/A |
Richards 2003a.
| Methods |
Location: Leeds, England Recruitment: Referral Exclusion rate: 44.4% Randomised (N): 139 (75 intervention; 64comparison) |
|
| Participants |
Disorder: Mixed (not specified); No diagnostic interview (questionnaire only) Duration (years): Unknown Age (years): 39.2 Sex (female): 84% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: No restrictions reported Medication: "judged to require immediate treatment with a new course of anti‐depressants" Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Treatment‐as‐usual Comparison description: GPs treated patients assigned to them in their 'usual' way. There were no restrictions on the type of care delivered. Intervention name: Managing Anxiety and Depression: A Self‐help Guide (Holdsworth and Paxton, 1999) Days of treatment: 28 Author wrote: No Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=2 (duration unknown) Contact description: Practice nurses assisted patients in using the booklet both within and between sessions. The programme comprised up to three sessions based on a previous trial evaluating a ‘two‐plus‐one’... The first two appointments, offered 1 week apart, focused on familiarisation with the booklet and applying it to samples of the patients’ problems. Patients then used the booklet at home and were offered a third review appointment (‘plus‐one’) 3 months later. Intervention description: Booklet CBT. 42 pages on A5 targeting anxiety, depression and related problems. Designed to be consulted, not read through. "Practice nurse‐facilitated self‐help. Practice nurses assisted patients in using a self‐help book — Managing Anxiety and Depression—a booklet developed for primary care, based on cognitive behavioural therapy techniques and previously subject to an outcome study." Compliance: 47 of those assigned to the intervention attended one or more appointments. |
|
| Outcomes | Quality of Life: EuroQol Thermometer | |
| Notes |
Funding: NHS: Northern and Yorkshire NHS Executive. Research and Development Levy from the Leeds Community and Mental Health Teaching Trust. Unpublished data: Barkham was unable to provide details at the time but would check if further information was available. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online "carried out using a computer‐generated random numbers table with practices blind to the randomisation strategy. Block randomisation was utilised in blocks of four patients per practice to prevent practice nurse workload becoming unmanageable. Patients were informed of their randomly allocated group within 24 hours and were requested to make the appropriate appointment at their surgery." |
| Allocation concealment (selection bias) | Low risk | "Patients were randomised once consent had been given. Randomisation was independent of the research team…" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "Practice nurses assisted patients in using the booklet both within and between sessions." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=16 (21.33%) Comparison: N=17 (26.56%) Method of analysis: LOCF Of those randomised 16/75 (21%) and 17/64 (27%) did not return consent forms. Observations carried forward for other participants, except for improvement (dichotomous) data. |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | High risk | Some participants who were randomised to usual care were given an appointment to receive the intervention and "it was considered unethical to rectify the error once the patient had commenced treatment." It is unclear if and how these participants appear |
Richards 2006.
| Methods |
Location: Melbourne, Australia Recruitment: Advertising/ Internet Exclusion rate: 52.94% Randomised (N): 32 (23 intervention; 9 comparison) |
|
| Participants |
Disorder: Panic disorder; ADIS (DSM‐IV) Duration (years): 12.7 Age (years): 36.59 Sex (female): 68.75% Race (white): 37.5% Medication (using at baseline): 37.5% Education (years): 13.16 EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: "Participants taking medication for anxiety or depression were included if they had been stabilised on it for at least 4 weeks but continued to experience panic symptoms and met a diagnosis of PD." Drug/Alcohol: "alcohol or drug dependency" Physical: "stroke...heart condition...chronic hypertension" |
|
| Interventions |
Comparison group(s): Attention/Monitoring Comparison description: These participants were required to participate in the same telephone and online assessments as those in PO1 and PO2. A Doctor of Psychology (Clinical) student contacted the IC participants each week by email and inquired about their current panic status. She provided minimal support and questioned participants as to whether they had been doing their daily monitoring and advised them to re‐read the information on this panic resource program that contained no active CBT information. Intervention name: Panic Online (Klein and Richards) Days of treatment: 68 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=13.45 (343 min) Contact description: a full clinical assessment using the ADIS‐IV and PDSS was conducted. This typically required 90 min. Sent 15.45 (5.32) emails and received 13.45 (13.05) emails. Combined treatment groups received 342.8 (135.97) minutes of therapist support. Intervention description: 1) "PO1 comprised four learning modules and introductory and relapse prevention modules that were designed to be completed over 8 weeks...instructions for controlled breathing, progressive muscle relaxation, cognitive restructuring and interoceptive and situational exposure..." 2) As before with stress management component. Compliance: Measured days in treatment, emails sent. |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ) General Symptoms: Anxiety Sensitivity Profile (ASP); Depression, Anxiety, Stress Scales (DASS): Anxiety Recovery: High End‐State Functioning Depression: Depression, Anxiety, Stress Scales (DASS): Depression Quality of Life: WHO Quality of Life ‐ BREF |
|
| Notes |
Funding: Australian Rotary Health Research Fund Unpublished data: Barkham was unable to provide details at the time but would check if further information was available. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear After all pre‐treatment assessment measures were completed by the participants, they were randomly allocated to one of the three conditions. |
| Allocation concealment (selection bias) | Unclear risk | The two assessors were the second author of the present study and a probationary registered psychologist/ PhD candidate. The second author was not blind to treatment allocation, although the other assessor was. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “all experienced in CBT for PD made email contact with the Internet‐based treatment (Panic Online: PO1) participants assigned to them and guided each through the program.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “The two clinicians who conducted the assessments did not provide any treatment.” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=3 (13.04%) Comparison: N=3 (33.33%) Method of analysis: LOCF Of the 32 people who commenced the study, five discontinued during treatment. The overall attrition rate for the present study was therefore 15.6%. The attrition rate for PO1 was 16.7% (2/12), 9% (1/11) in PO2 and 22% (2/9) in IC. Reasons given for discontinuing the treatment in the PO1 condition were a lack of motivation or an episode of major depression. The PO2 person discontinued because of a wish to commence selective serotonin reuptake inhibitor medication halfway through the study. Of the two IC participants, no reason for discontinuing was given. |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Unclear risk | N/A |
Robinson 2010.
| Methods |
Location: National, Australia Recruitment: Advertising/ Internet Exclusion rate: 27.18% Randomised (N): 150 (101 intervention; 49 comparison) |
|
| Participants |
Disorder: GAD; MINI (DSM‐IV) Duration (years): N/A Age (years): 47 Sex (female): 68.28% Race (white): N/A% Medication (using at baseline): 32.4% Education (years): 14.38 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "if taking medication, had been taking the same dose for less than 1 month or intending to change that dose during the course of the program" Drug/Alcohol: "using illicit drugs or consuming more than three standard drinks/day" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: The Worry Programme Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Home/ Anywhere Type of contact: Email & Phone Automated contact: N= 11 Provider contact: N=11 (78 min) Contact description: "Automatic emails are sent to congratulate participants for completing each lesson, to remind them..." Group 1 (75min): “weekly email or telephone…given a guideline script…provide encouragement and support, and where possible to respond to participants’ general questions.” Group 2 (81 min): “weekly email or telephone…access to an online discussion forum…provided with the same guideline script as the technician but was also instructed to answer participants’ questions via forum, email, or telephone. The clinician was instructed to actively engage with each participant in treatment...” Intervention description: "… six online lessons…cognitive therapy, challenging meta‐beliefs about worry, graded exposure, challenging core beliegs, and relapse prevention...printable summary and homework assignments…illustrated story about a woman with GAD…" Compliance "Forty (40/50, 80%) TA and 35/47 CA (74%) group participants completed all 6 lessons within the required time. Reasons for not completing all lessons were not collected." |
|
| Outcomes |
Specific Symptoms: Generalised Anxiety Disorder Assessment (GAD 7); Penn State Worry Questionnaire (PSWQ) General Symptoms: Social Interaction Anxiety Scale (SIAS); Penn State Worry Questionnaire (PSWQ) Response: Generalised Anxiety Disorder Assessment (GAD 7) Depression: Patient Health Questionnaire (PHQ‐9) Disability: Sheehan Disability Scale (SDS) Psychiatric Distress: Kessler 10 (K‐10) |
|
| Notes | Funding: Australian Rotary Health Research Fund | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online "NT via a true randomisation process (www.random.org)" |
| Allocation concealment (selection bias) | Low risk | "Allocation preceded the diagnostic telephone call." "by contacting the holder of the allocation schedule who is off‐site." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk |
Provider contact: Yes Provider blind: No "weekly email or telephone" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=4 (3.96%) Comparison: N=0 (0.00%) Method of analysis: LOCF |
| Selective reporting (reporting bias) | Low risk |
Trial registration number: ACTRN12609000563268 All outcomes reported. |
| Other bias | Low risk | N/A |
Rosen 1976.
| Methods |
Location: Eugene (Oregon), USA Recruitment: Advertising/ Internet Exclusion rate: Unknown Randomised (N): 55 (22 intervention; 11, 11 comparison) |
|
| Participants |
Disorder: Specific Phobia; Other Duration (years): 25.9 Age (years): 33.5 Sex (female): 90.7% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐list, Individual exposure Comparison description: 1) Wait list 2) "Subjects in this group met twice a week with one of five graduate student therapists…weekly group meetings that were held over a 3‐month period prior to treatment. A common set of instructional materials was used as part of the training program." Intervention name: A manual for self‐administering systematic desensitization in your home (GM Rosen, 1974) Days of treatment: 56 Author wrote: Yes Type of media: Book / Booklet Type of therapy: Muscle Relaxation Location used: Anywhere Type of contact: Phone Automated contact: N=0 Provider contact: N=8 (45.6min) Contact description: Two groups combined for analysis. 1) No contact. 2) "During these phone calls, therapists served as consultants who answered questions and made procedural suggestions. Calls ranged from 4 to 49 minutes with an average time per call of 11.4 minutes." Intervention description: 2 groups combined: 1) "A log sheet accompanied the program...In addition to written materials, subjects were given a record of relaxation instructions (Kahn, cited in Kahn & Baker, 1968, p. 198) to help them learn varied instructional phrases. Subjects were instructed to always conduct practice sessions on their own and to not rely on recorded procedures." 2) "In addition, subjects received weekly phone calls from the same therapists who worked with clients in the clinic group." Compliance: 47% completed at least half of their hierarchy. 67% of the face‐to‐face comparison completed their entire programme. |
|
| Outcomes |
Specific Symptoms: Fear Survey Schedule: Snake Behaviour Test (Level): Behavioural Approach Test: Level Behaviour Test (Symptoms): Behavioural Approach Test: Symptom Rating Response: Behavioural Approach Test: Completed |
|
| Notes |
Funding: National Institute of Mental Health. "Grant MH256S7‐01" Unpublished data: Contacted Barrera and Rosen. They were unable to provide further information. Did not extract data for the "placebo" control, information about snakes (11 participants not included). |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “After pretreatment assessments had been completed, the subjects were matched on behavior approach scores and assigned by block randomization to one of four treatment groups or a no‐treatment control.” |
| Allocation concealment (selection bias) | Unclear risk | “Pretreatment to posttreatment and follow‐up assessments of subjects' attitudes and reactions toward snakes were conducted by assistants blind to subjects' group assignment.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “During these phone calls, therapists served as consultants who answered questions and made procedural suggestions.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “Pretreatment to posttreatment and follow‐up assessments of subjects' attitudes and reactions toward snakes were conducted by assistants blind to subjects' group assignment." |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=5 (22.73%) Comparison (no‐treatment): N=4 (36.36%) Comparison (face‐to‐face): N=2 (18.18%) Method of analysis: Available Case Assumed equal allocation to groups. All participants in the original study sent a follow‐up questionnaire. Because measures included a desensitisation technique involving a four foot snake, data for 42% of desensitization subjects who were unable to be in a room with the snake could not be used. 23 of desensitisation subjects and 11 of 17 controls responded. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. In addition to the scales extracted, the report suggests that other measures may have been used. Follow‐up data are not reported in sufficient detail to include in meta‐analysis. |
| Other bias | Low risk | N/A |
Rosmarin 2010.
| Methods |
Location: Jewish communities, International Recruitment: Advertising/ Internet Exclusion rate: 46.3% Randomised (N): 261 (106 intervention; 72, N/A, 83 comparison) |
|
| Participants |
Disorder: Mixed (not specified); No diagnostic interview (questionnaire only) Duration (years): Unknown Age (years): 41.8 Sex (female): 76.6% Race (white): Unknown Medication (using at baseline): Unknown Education (years): 15.32 EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: "no changes in psychotropic medication (type or dosage) during the 8‐weeks before treatment" Drug/Alcohol: "no past or current diagnosis of substance abuse" Physical: "traumatic brain injury, current life threatening illnesses" |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Not named Days of treatment: 14 Author wrote: Yes Type of media: Internet Type of therapy: Muscle Relaxation Location used: Anywhere Type of contact: Email Automated contact: N=14 Provider contact: Unknown Contact description: To encourage participation in the treatment programs, participants in the active treatment groups received a daily email reminder about their treatment period "To facilitate compliance, email messages prompting participants to complete the post‐treatment and follow‐ up assessments were sent on a daily basis until the assessments were completed." Intervention description: Progressive muscle relaxation. Relaxation: tensing and relaxing 16 different muscle groups. Instructions presented audibly, asked to practice relaxation throughout daily life. Provided with link so that they could print summary of PMR program. 10 minute information‐orientation video. Use techniques once per day. Compliance: Completion of daily treatment was tracked electronically to provide information about how many sessions each participant completed. |
|
| Outcomes |
Specific Symptoms: Penn State Worry Questionnaire (PSWQ) Depression: Center for Epidemiologic Studies Depressed Mood Scale (CESD) |
|
| Notes | Despite the title, this does not appear to be CBT. Included only the relaxation condition as a treatment group. "The SI‐CBT contained four components: (1) an introduction; (2) a cognitive component consisting of stories and readings, in which participants were encouraged to think about what it means to trust in God, and the role of God in their lives; (3) a behavioral component consisting of spiritually integrated strategies designed to increase awareness of God’s benevolence and care; and (4) a brief prayer for Divine assistance..." Funding: “This study was supported by a generous grant from a private Jewish community foundation in Toronto, Canada." Unpublished data: Extracted outcomes and characteristics from thesis. The text of the spiritual intervention is included in the thesis. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “After completing the screening procedure, eligible participants were automatically randomly assigned to one of the three study conditions using a computer‐generated allocation sequence and hence no blinding/masking was necessary.” |
| Allocation concealment (selection bias) | Low risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unclear if there was any contact with researchers or clinicians. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=65 (61.32%) Comparison (wait‐list): N=24 (33.33%) Method of analysis: Available Case “The remaining 261 participants were randomized to the SI‐CBT group (n= 83), the PMR group (n = 106) or the WLC group (n = 72). Contact was lost with 65 participants who did not complete the pre‐treatment (baseline) assessment. Of the remaining 202 participants, 77 participants did not complete the post treatment assessment, and an additional 29 participants did not complete the follow‐up assessment. Thus, analyses were conducted with 125 participants who completed the pre‐ and post‐treatment assessments, of which 96 participants also completed the follow‐up assessment." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Ruwaard 2010.
| Methods |
Location: Amsterdam, Holland Recruitment: Advertising/ Internet Exclusion rate: 64.63% Randomised (N): 58 (27 intervention; 31 comparison) |
|
| Participants |
Disorder: PAs; Clinical Interview (DSM‐IV) Duration (years): 9.40 Age (years): 38.74 Sex (female): 72.41% Race (white): Unknown Medication (using at baseline): 29.31% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "no use of neuroleptic medication; no use of anxiolytics or antidepressants for less than three months or use of unstable doses (i.e., clients took medications as prescribed and in the targeted dosage)" Drug/Alcohol: "no drug abuse" Physical: "absence of a medical condition that might explain panic symptoms" |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Interapy Days of treatment: 77 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Home/ Anywhere Type of contact: Email Automated contact: N= 0 Provider contact: N=14 (450min) Contact description: "At specific occasions indicated in the manual, therapists post feedback and further instructions on the basis of the contents of this workbook. Therapists take about 20–40 min to read a client’s assignment, and to prepare feedback. The manual includes 14 of these feedback moments, so that a full treatment requires between 5 and 9 h of therapist time." Intervention description: “seven treatment modules…attacks are explained…Panic Diary…breathing retraining…encouraged to expose…educated about different forms of exposure (in vitro/in vivo/ interoceptive)…cognitive restructuring…formulate a ‘relapse prevention toolkit’” Compliance: "read a client’s assignment, and to prepare feedback" |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ); Body Sensations Questionnaire (BSQ); Mobility Inventory for Agoraphobia (MIA): Alone; Panic Attacks: Frequency (Full Attacks); Panic Attacks: Intensity (Full); Panic Disorder Severity Scale, self‐rated (PDSS‐SR) General Symptoms: Penn State Worry Questionnaire (PSWQ) Response: Panic Attacks: Frequency Depression: Depression, Anxiety, Stress Scales (DASS): Depression |
|
| Notes | Funding: The Netherlands Organization for Health Research and Development and Interapy | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear "The participants were randomly assigned to two groups." |
| Allocation concealment (selection bias) | Unclear risk | See "Sequence Generation." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk |
Provider contact: Yes Provider blind: No "read a client’s assignment, and to prepare feedback." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0.00%) Comparison: N=0 (0.00%) Method of analysis: LOCF |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Salaberria 1995.
| Methods |
Location: Basque Country, Spain Recruitment: Advertising and referral Exclusion rate: 23.81% Randomised (N): 80 (27 intervention; 27 comparison) |
|
| Participants |
Disorder: Social Anxiety (Specific); ADIS (DSM‐III R) Duration (years): 10 Age (years): 31 Sex (female): 48% Race (white): 0% Medication (using at baseline): 0% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: "substance abuse" Physical: No "incapacitating illness.” |
|
| Interventions |
Comparison group(s): SH + Group CBT versus CBT alone Comparison description: Group therapy without self‐help. Participants in all groups received group therapy focusing on self‐exposure homework (8 x 2.5 hours). One group received cognitive therapy. Intervention name: Managing Anxiety (Butler, 1985) [translated] Days of treatment: 56 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=8 (1200 min, common to both groups) Contact description: All groups received group therapy with approximately 1200 minutes during treatment. Intervention description: Within two group therapy comparisons, participants were randomised to self‐help or no self‐help. Taught to identify and question automatic thoughts and to suggest alternative responses. Cognitive restructuring exercises. Compliance: Compliance with the booklet not reported. "record keeping sheets are distributed so that patients may take notes at home on said exercises" |
|
| Outcomes | None included. | |
| Notes |
Funding: University of Basque Country (UPV 006.230‐H067/90 Research Grant) Unpublished data: Echeburúa replied that they have no further information but estimated that "participants were Caucasian, they had about 15 years of education and the disorder lasted for more than 10 years. At the start of the trial nobody was on medication." |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “Patients were randomly assigned to the three groups, after they had been preliminarily stratified according to age and gender…At the same time, and given that another of the aims of this study was to assess the additional efficacy of a self‐help manual for management of anxiety, a factorial 2x2 design was used...” |
| Allocation concealment (selection bias) | Unclear risk | See "Sequence Generation" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind). All groups received group therapy. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=5 (18.52%) Comparison: N=4 (14.81%) Method of analysis: Per protocol 9 lost before treatment began (7 failed to attend the evaluation, 2 failed to initiate treatment). "The number of dropouts in all phases was 15 (3 of them control group participants). Thus, the total number of refusals, dropouts, and loss of patients in all groups comes to 17..." The "control group" was not part of the factorial study and was not included; assumed equal allocation to groups. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. The main comparison in this trial is not eligible. Within the two main comparisons, the self help groups can both be included, though only one outcome is reported. Authors note that all others were non‐significant. |
| Other bias | Low risk | N/A |
Schneider 2005.
| Methods |
Location: London, England Recruitment: Advertising and referral Exclusion rate: 27.66% Randomised (N): 68 (45 intervention; 23 comparison) |
|
| Participants |
Disorder: Mixed (AG, SAD, SP); Clinical Interview (ICD‐10) Duration (years): 14 Age (years): 39 Sex (female): 73.53% Race (white): 61.76% Medication (using at baseline): 61.76% Education (years): 12 EXCLUSIONS Depression: Yes Psychotherapy: Previous psychotherapy restricted Medication: "not on a benzodiazepine or diazepam‐equivalent dose of 15 mg/day" "not begun or changed dose or type of antidepressant within the last 4 week" Drug/Alcohol: "drank <21 units (men) or <14 units (women) of alcohol a week" Physical: "disabling cardiac or respiratory disease" |
|
| Interventions |
Comparison group(s): Muscle relaxation (self‐help) Comparison description: Internet CBT without exposure. Book (Managing Anxiety) plus audio CD with progressive muscle relaxation. "...7 rather than 9 modules and encouraged a similar amount of time spent at the computer and on homework (but of a non‐exposure kind)." "...asked them to do at least a week of homework between each of the 6 sessions..keep a mood diary...note anxiety triggers...taught the reason for practising relaxation..positive thoughts...healthy habit diary...coping responses..." Intervention name: Fear Fighter (Marks 2004) Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: Exposure Location used: Anywhere Type of contact: Email & Phone Automated contact: N=0 Provider contact: N=6 (115min) Contact description: “Immediately after randomisation, patients were e‐mailed (n = 59) or posted (n = 9): (a) their assigned 3 pages of user instructions..." "All patients had 6 scheduled brief therapist contacts by phone or e‐mail' "40 min on the telephone screening interview. Excluding screening time, their mean 8 SD time spent per patient supporting and rating patients by phone totalled: (a) during treatment weeks 0–10: FF 115 ± 44 min, MA 87 ± 28 min, F(1,46)=5.0, p=0.03; of this time, 80% were spent giving support, 17% obtaining ratings and 3% giving technical advice.." Intervention description: Net‐accessed FF had 9 self‐exposure steps to be completed in 6 sessions Daily self‐exposure homework diaries. Compliance: 5.9 (0.4) treatment sessions intervention, 5.7 (1.0) control. 44(43) hours doing homework, 29(58) control. |
|
| Outcomes |
Specific Symptoms: Fear Questionnaire (FQ): Global Phobia, assessor rated General Symptoms: Fear Questionnaire (FQ): Anxiety Depression; Fear Questionnaire (FQ): Total Phobia Disability: Work and Social Adjustment Scale (WSAS); Work and Social Adjustment Scale (WSAS), assessor rated |
|
| Notes |
Funding: EU Marie Curie Fellowships supported Dr. Schneider and Dr. Mataix‐Cols. The Leeds Community and Mental health Services NHS Trust gave a grant towards and referred patients for the trial. Unpublished data: Marks forwarded queries to Andreas J. Schneider who did not reply. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Mechanical “Stratifying for phobia type (agoraphobia, social and specific phobia), patients were randomised…” See allocation concealment. |
| Allocation concealment (selection bias) | Low risk | “At the end of the telephone screening interview, the interviewer found the randomly assigned treatment condition for the suitable patients by opening the next opaque, sealed envelope in a previously mixed up pile of trial‐numbered envelopes in the required 2:1 ratio. Each envelope contained a card noting the randomised treatment for a given patient’s trial number." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) 6 scheduled brief therapist contacts by phone |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “During rating interviews, the treatment group was in‐advertently revealed to the rater by 1 patient at week 0, 6 patients at week 10 and 4 patients at week 14. Excluding those, the blinded rater’s guesses as to the patient’s treatment condition were no better than chance at weeks 0 (kappa = 0.12, p = 0.22) and 10 (kappa = –0.02, p = 0.81) but slightly better than chance at week 14 (kappa= –0.3, p = 0.026)." |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=12 (26.67%) Comparison: N=8 (34.78%) Method of analysis: Available Case “Intention‐to‐treat outcome analysed all randomised patients in the group to which they were originally randomised [16]. Where postbaseline data were unavailable, baseline data were not carried forward in the manner often done, as it is unlikely that scores remained frozen at their last observed value [17].” "At week 14, data of 44 (91%) patients were available (31 FF, 13 MA)." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Seekles 2011.
| Methods |
Location: Amsterdam, Holland Recruitment: Referral Exclusion rate: 89.14% Randomised (N): 120 (60 intervention; 60 comparison) |
|
| Participants |
Disorder: Mixed (GAD, PD, SAD; 93% had an anxiety disorder, 44% had only an anxiety disorder); CIDI (DSM‐IV) Duration (years): 21.5 Age (years): 50.6 Sex (female): 66.67% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: "receiving current (less than 2 months) treatment (medical/psychotherapy) for psychological problems" "Benzodiazepines were allowed in both study groups. Patients in the stepped care group were only allowed to receive antidepressants in later phase of the treatment protocol." Drug/Alcohol: "severe alcohol problems (N20 on the Alcohol Use Disorders Identification Test (AUDIT)" Physical: N/A |
|
| Interventions |
Comparison group(s): Treatment‐as‐usual Comparison description: Treatment as usual (wait‐list). "Patients in the care as usual who responded (n=38) received the following care: 21 (55%) went to their GP, 10 (26%) received mental health care (psychiatric nurse, specialized mental health care, a psychiatrist or a psychotherapist), 2 (5%) went to a medical specialist, 1 (3%) went to a social worker and 4 (11%) went to some form of complementary and alternative medicine. Nine patients (24%) received benzodiazepines but none of them received antidepressants." Intervention name: Problem Solving Treatment (van Straten et al., 2008) and exposure (Cuijpers and De Neef, 2007) Days of treatment: 35 Author wrote: Yes Type of media: Mixed Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=1 (duration unknown) Contact description: For PST: "If they applied for feedback, they were supported by email (the Internet group) or by telephone (the book group). ..." For exposure: "Feedback is therefore provided by telephone." "For both: "During the first session, the psychiatric nurse decides together with the patient, and based on the symptoms, which self‐help course is most suitable." "None of the patients who received a self‐help intervention via book (PST or Phobias) contacted the coach for feedback." Intervention description: “The first is a generic intervention based on Problem Solving Treatment (PST)…(van Straten et al., 2008)… could choose to follow this course via the Internet or by using a book… The second self‐help intervention is aimed specifically at patients with phobias and is based on exposure therapy (Cuijpers and De Neef, 2007)… make a plan to practice exposure…takes six weeks to complete and is only available as a book.” Compliance: 28% self‐help via internet, 32% self‐help via book, 15% self‐help for phobias, 10% refused. "The 16 patients who performed the PST online completed 1.13 (SD=1.4) out of 6 lessons on average. It is however not possible to draw any conclusions from this number because all patients with a book or internet and who did not fill in their homework online are not included." |
|
| Outcomes |
General Symptoms: Hospital Anxiety and Depression Scale (HADS) Response: Clinically Significant Improvement (Composite) Depression: Inventory of Depressive Symptomatology (IDS) Quality of Life: Medical Outcomes Study Short Form (SF‐36) |
|
| Notes |
Funding: “We would like to thank GGZ‐inGeest and Mentrum for providing specialized mental health care and for supervising psychiatric nurses/psychologists in the intervention.” Some results are reported separately for people with anxiety and depression. For anxiety and depression, we analysed those with anxiety only and those with comorbid anxiety/depression. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “computer‐generated block randomization” |
| Allocation concealment (selection bias) | Low risk | “An independent researcher, not involved in the current project, used computer‐generated block randomization to produce sealed envelopes. After every inclusion the researcher opened a sealed envelope." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “GPs were informed which patients were randomized to the stepped care program to ensure that the patient received treatment from the GP and to ensure adherence to the stepped care protocol.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=5 (8.33%) Comparison: N=7 (11.67%) Method of analysis: Available Case “Twelve (10.0%) of the 120 randomized participants reported severe dysfunctioning on the WSAS…were referred to the last step of our stepped care model (psychotherapy or medication) and…are excluded from the current analysis.” "Missing items on questionnaires were imputed using a Two‐Way Imputation of Missing Test Data (Sijtsma and Van der Ark, 2003)...Missing total scores on questionnaires (because respondents did not return the questionnaire) were imputed using regression imputation." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Sharp 2000.
| Methods |
Location: Fort Valley, UK, Scotland Recruitment: Referral Exclusion rate: 21.21% Randomised (N): 104 (35 intervention; 36 comparison) |
|
| Participants |
Disorder: Panic disorder; Clinical Interview (DSM‐III R) Duration (years): 2.67 Age (years): 39.4 Sex (female): 68.12% Race (white): 46.67% Medication (using at baseline): 46.67% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current and previous therapy restricted Medication: "Any patients taking concurrent psychotropic medications were required to have taken them for two months prior to study entry, and to continue taking them as prescribed throughout the study period." Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Individual CBT Comparison description: All patients received the same CBT and all received identical treatment instructions, the same written treatment manual being supplied to all patients. "Patients in the standard contact condition received the standard treatment manual and eight sessions of 45 minutes’ duration over 12 weeks with sessions at Days 0, 7, 14, 28, 42, 56, 70, and 84; a total of six hours’ therapist contact." Intervention name: Similar to: Psychological Treatment of Panic (Barlow and Cerny, 1988) Days of treatment: 84 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=2 (60min) Contact description: “Patients in the bibliotherapy condition received the treatment manual and assessment sessions at Days 0, 42, and 84. The one hour and 30 minutes of therapist contact in this condition was for assessment only, with treatment instruction provided solely by the treatment manual.” Intervention description: “...emphasised the alteration of the action tendencies associated with panic attacks and the hypervigilant and avoidant information processing and behaviours typical of panic disorder and agoraphobia. Patients were encouraged to confront their panic attacks—during exposure outings if necessary—and to attempt to replace behavioural and cognitive avoidances with more approach‐centred actions. This approach to CBT was similar to that of Barlow and co‐workers...” Compliance: None reported. |
|
| Outcomes |
Specific Symptoms: Fear Questionnaire (FQ): Agoraphobia General Symptoms: Hamilton Anxiety Rating Scale, clinician‐rated (HAM‐A) Response: Panic Free Depression: Montgomery and Asberg Depression Rating Scale (MADRS) Disability: Sheehan Disability Scale (SDS): Family/Home; Sheehan Disability Scale (SDS): Social/Leisure |
|
| Notes |
Funding: None acknowledged Unpublished data: Author provided details of the randomisation, allocation concealment and baseline characteristics. Confirmed no measures of compliance. Unable to provide further information about dropouts. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “Randomisation was conducted according to a computer‐generated randomisation schedule, with individual allocations unavailable until after initial assessment.” |
| Allocation concealment (selection bias) | Low risk | “Administered using opaque envelopes.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “patients were seen for assessment prior to treatment group randomisation and thereafter for treatment by the same clinical psychologist” "Patients in the standard contact condition received the standard treatment manual and eight sessions of 45 minutes..." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “Treatment end‐point assessments were conducted by an independent clinical psychologist (KP) and patients were instructed not to discuss their treatment with the blind endpoint assessor.” |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=6 (17.14%) Comparison: N=5 (13.89%) Method of analysis: Available Case “Patients withdrawing early owing to effectiveness or ineffectiveness of treatment, receiving at least 42 days treatment, and who provided full endpoint data, were included in the final analysis as ‘defined completers’…A total of 91 ‘full completers’ and ‘defined completers’ comprised the study group.” |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Data from panic diaries are partially reported. 6‐week data are not reported in one paper, though they appear in the other. 6‐month follow‐up are not reported in full. |
| Other bias | High risk | Data are reported in two papers that do not reference each other and which report partial outcomes and time points. 6‐month outcomes are reported for a subgroup of participants, and these outcomes were not extracted. |
Shoenberger 2008.
| Methods |
Location: Reno, Nevada, USA Recruitment: College only Exclusion rate: Unknown Randomised (N): 57 (30 intervention; 27 comparison) |
|
| Participants |
Disorder: Generalised Anxiety Disorder; No diagnostic interview (questionnaire only) Duration (years): Unknown Age (years): 28 Sex (female): 100% Race (white): 22% Medication (using at baseline): 22% Education (years): 14 EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: "Participants had not initiated any psychiatric medications 30 days prior to enrolling in the study, and did not change doses of psychiatric medications that she was taking for longer than 30 days, during the course of the treatment." Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Treatment‐as‐usual Comparison description: “The control condition consisted of 27 participants who did not receive the self‐ help book, but could be seeking services from other healthcare providers such as physicians and the university counseling center.” Intervention name: Women Who Worry Too Much Days of treatment: 28 Author wrote: No Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=4 (duration unknown) Contact description: “Intervention participants were contacted weekly via e‐mail by the co‐investigator. The weekly e‐mail contacts were non‐directive check‐ins which were designed to provide intervention participants with an opportunity to ask questions about specific techniques or exercises. This opportunity was provided in order to minimally address concerns about treatment accuracy.” Intervention description: “The book contained information about chronic worry and evidence‐based CBT skills including: behavioral activation, relaxation, problem‐solving, perspective taking, identifying and managing unhelpful thoughts, and assertiveness skills targeting reduction of the frequency and intensity of chronic worry. Participants were instructed to practice these techniques and exercises as frequently as possible throughout the four‐week intervention.” Compliance: “Intervention compliance was assessed using a self‐report continuum with 0 being ‘did not use at all’ and 100 being 'used completely.' Overall, intervention participants (N = 30) reported moderate utilization of the self‐help materials (M = 49.33, SD = 27.16).” |
|
| Outcomes |
Specific Symptoms: Generalized Anxiety Disorder Questionnaire–IV General Symptoms: State‐Trait Anxiety Inventory (STAI) Depression: Center for Epidemiologic Studies Depressed Mood Scale (CESD) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes |
Funding: None acknowledged |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Other “Participants were randomly assigned to one of two conditions before the intervention using a table of random numbers.” |
| Allocation concealment (selection bias) | Unclear risk | N/A |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Intervention participants were contacted weekly via e‐mail by the co‐investigator.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropout. |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Silfvernagel 2012.
| Methods |
Location: Stockholm, Sweden Recruitment: Advertising/ Internet Exclusion rate: 61.74% Randomised (N): 57 (29 intervention; 28 comparison) |
|
| Participants |
Disorder: Panic Attacks; SCID (DSM‐IV) Duration (years): N/A Age (years): 32.4 Sex (female): 64.91% Race (white): 47.37% Medication (using at baseline): 47.37% Education (years): 13.44 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "if on medication it had to be on stable dosage for the last three months" Drug/Alcohol: "not be at risk of alcohol abuse or fulfilling the criteria for current alcohol addiction" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Not named Days of treatment: 56 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=19 (120min) Contact description: “If the participant had not sent in their homework...therapist would send out an email reminder. The therapists were instructed to check whether the participants had completed the assignments...and to provide individual feedback within 24 hours. If the therapist believed that the participant was ready to move on with their treatment the next module was made available...approximately 15 min per week per participant (estimated), which included administration as well as reading and responding to emails (estimated 19 emails between therapist and participant throughout the treatment)...” Intervention description: “The treatment consisted of 19 CBT modules derived from previous iCBT trials on panic disorder [31], generalized anxiety disorder, social phobia [32], depression [33] and tailored iCBT for anxiety [17, 18] and depression. In this trial the first module (introduction) and the last module (relapse prevention) were fixed and the following 17 were optional for the therapists to prescribe...” Compliance: “Seven (24.1 %) out of the 29 participants completed all prescribed modules (6‐8) within the eight week treatment period. A total of 17 participants (59.0 %) completed 50 per cent of prescribed modules and 14 (48.3 %) completed 75 per cent of prescribed modules. Mean for number of completed modules for the whole group was M=5.0” |
|
| Outcomes |
Specific Symptoms: Panic Disorder Severity Scale (PDSS) General Symptoms: Beck Anxiety Inventory (BAI) Response: Panic Disorder Severity Scale (PDSS) Depression: Montgomery and Asberg Depression Rating Scale (MADRS) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes | Funding: Swedish Council for Working Life and Social Research | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “The blocked randomization process was conducted through an online true random‐number service (random.org)" |
| Allocation concealment (selection bias) | Low risk | "independent of the investigators and therapists.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “The therapists were instructed to check whether the participants had completed the assignments…” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “At post treatment participants were instructed via email to complete the follow‐up questionnaires and to participate in a semi‐structured telephone interview carried out by a blinded assessor who had no earlier contact with the participants. The same procedure was repeated at twelve months after treatment completion. We used the PDSS as the primary outcome measure in the trial." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: Mixed effects “A mixed models approach with an unstructured covariance structure was endorsed as a way to handle missing data at post treatment and at the 1 year follow up.” |
| Selective reporting (reporting bias) | Low risk |
Trial registration number: NCT01296321 Protocol suggests follow‐up analyses should be forthcoming. |
| Other bias | Low risk | N/A |
Smith 1997.
| Methods |
Location: Tasmania, Australia Recruitment: Advertising/ Internet Exclusion rate: 0% Randomised (N): 49 (33 intervention; 16 comparison) |
|
| Participants |
Disorder: Specific Phobia; CIDI Auto (DSM‐III R) Duration (years): 22.7 Age (years): 34.8 Sex (female): 97.96% Race (white): 0% Medication (using at baseline): 0% Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: "none were taking anxiolytic medication" Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Attention/Monitoring Comparison description: “The vignette portrays a phobia of elevators. The scenario ranges from at home, along a street, and into a building of seven floors with an elevator. The anxiety thermometer is operating and the score system rewards approach and riding in the elevator." Intervention name: CAVE (Smith 1997) Days of treatment: 42 Author wrote: Yes Type of media: Computer Type of therapy: Exposure Location used: Clinic/ Surgery Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=3 (15min) Contact description: Author estimated 45 minutes for the CIDI for duration of face‐to‐face assessment. For treatment, therapist stayed 5 min to answer questions and remained available in another room for assistance. Estimated 15 min contact over three sessions. Intervention description: 1) "you are asked to help a person on the screen to overcome a specific anxiety problem ‐ fear of x (i.e., spiders/lifts [elevators])... The vignette in the introductory section refers to spider phobia. Subjects have the choice of systematically exposing the screen figure to a variety of anxiety‐evoking situations, ranging from mild to severe (spider picture, plastic spider, dead spider, or live spider). The anxiety thermometer is operating. " 2) "The anxiety thermometer is omitted." Compliance: “subjects in the RENoF group reported fewer new activities than the other two groups...but the main effect failed to reach statistical significance...homework activities correlated significantly with clinical improvement as indexed by the SPQ (r = ‐0.441, p < 0.01), but was not significantly correlated with improvements on the SQ or problem and target ratings...more new homework activities showed a greater fall in SPQ scores.” |
|
| Outcomes |
Specific Symptoms: Phobic Targets: Phobic Problem Disability: Work and Adjustment Rating Scale (WARS) |
|
| Notes |
Funding: None acknowledged Unpublished data: Gilroy did not have further information about missing participants. Provided details about contact and methods. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “Subjects were randomized to one of three treatment groups…” |
| Allocation concealment (selection bias) | Unclear risk | N/A |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “During treatment, the therapist stayed 5 min to answer questions and remained available in another room for assistance.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=3 (9.09%) Comparison: N=1 (6.25%) Method of analysis: Per protocol Three subjects dropped out before completing all treatment sessions and a fourth subject was excluded from the analysis due to missing data. "Seven of 45 subjects did not complete the 6‐ to 12 month follow‐up (3 from IF group, 3 from REF and 1 from RENoF) due to 1 subject receiving treatment for spider phobia following the posttreatment sessions, and others experiencing changes in personal circumstances, such as moving from the state. No additional treatment was sought by the remaining subjects during the follow‐up." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Sorby 1991.
| Methods |
Location: Southampton & Portsmouth, England Recruitment: Referral Exclusion rate: Unknown Randomised (N): 64 (33 intervention; 31 comparison) |
|
| Participants |
Disorder: Mixed (GAD, PD); SCID (DSM III R) Duration (years): Unknown Age (years): Unknown Sex (female): 81.25% Race (white): 67% Medication (using at baseline): 67% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: No restrictions reported Medication: "to minimize the effects of medication, it was agreed that no changes in psychotropic medication were to be made at the start or within the first two weeks of the study…" Drug/Alcohol: "...alcohol or substance misuse were excluded" Physical: N/A |
|
| Interventions |
Comparison group(s): Treatment‐as‐usual Comparison description: “Patients in the control group were not made aware of the booklet.” Intervention name: Anxiety‐An explanation and self‐help manual (Sorby and Reavley). Days of treatment: 56 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=4 (90min) Contact description: At the end of the interview, members of the experimental group were given a copy of the booklet Anxiety‐ an explanation and self help manual (written by NS and WR) and up to 10 minutes were spent explaining the contents. "Patients were asked to return to their doctor two, four and eight weeks after the initial consultation. Directly after each visit the patients completed the questionnaires used at the first session, at home, and returned them to the surgery by post or by hand." About 30 minutes of contact with a GP and 60 minutes of contact with a researcher (personal communication). Intervention description: “The booklet describes how anxiety operates in terms of the three factor theory of physical, mental and avoidance components. How these components relate to each other and operate to create and maintain anxiety is outlined. Advice is given on how readers can intervene at different stages in the anxiety cycle and develop confidence in coping strategies which they are encouraged to apply in a range of situations, and on how they can monitor their progress.” Compliance: Other treatments received were not measured. |
|
| Outcomes |
General Symptoms: Hospital Anxiety and Depression Scale (HADS): Anxiety Depression: Hospital Anxiety and Depression Scale (HADS): Depression |
|
| Notes |
Funding: None acknowledged Unpublished data: Sorby provided details about randomisation and demographic characteristics. "Looks like I calculated the depression values from the total HADS score and the anxiety score." |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Mechanical “After agreeing to take part in the study patients were randomly allocated...using a random card pack.” "The random card pack was literally a series of cards in brown envelopes that were shuffled and picked at random." |
| Allocation concealment (selection bias) | High risk | "One of the authors (NS) arranged to call on each patient within 72 hours to collect the completed questionnaire and to carryout a structured clinical interview for DSM II, to confirm the subjects' suitability for the trial." "Following the structured clinical interview, two women and one man in the control group, and one woman in the booklet group were excluded as they failed to meet the inclusion criteria." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) Participants in the control group were not aware of the booklet (the intervention). "Patients were asked to return to their doctor two, four and eight weeks after the initial consultation." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=3 (9.09%) Comparison: N=12 (38.71%) Method of analysis: Available Case “Three men and one woman in the control group dropped out but there were no dropouts from the booklet group. Five women in the control group and two women in the booklet group failed to complete the questionnaires satisfactorily. Following the structured clinical interview, two women and one man in the control group, and one woman in the booklet group were excluded as they failed to meet the inclusion criteria. Thus, 49 patients (76.6%) successfully completed the trial‐ 30 in the booklet group (90.9%) (23 women and seven men) and 19 in the control group (61.3%) (18 women and one man).” |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Tarrier 1986.
| Methods |
Location: Manchester, England Recruitment: Referral Exclusion rate: Unknown Randomised (N): 40 (20 intervention; 10 comparison) |
|
| Participants |
Disorder: Generalised Anxiety Disorder; Unclear Duration (years): 5.34 Age (years): 40.5 Sex (female): 60% Race (white): 68% Medication (using at baseline): 68% Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: No restrictions reported Medication: "those who thought their medication was no longer producing any improvement were included, and were asked to continue taking their medication." Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐list, Rexlation Comparison description: 1) Wait‐list, 2) Relaxation therapy taught by demonstration. Intervention name: Not named Days of treatment: 42 Author wrote: Yes Type of media: Mixed Type of therapy: Applied Relaxation Location used: Clinic/ Surgery Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: Contacted for referral and assessment. No contact during the trial reported. Intervention description: Two eligible groups: 1) Booklet relaxation. 2) Taped relaxation. "All patients received a rationale for applied relaxation training...(a) self‐monitoring of anxiety levels; (b) correct breathing monitoring of breathing and the use of exercises to encourage diaphragmatic breathing; (c) progressive muscle relaxation, consisting of tension release exercises; (d) positive mental imagery." Compliance: “One third of the group had complied with the instructions on 14 days or less; about 25% practised on 29 days or more. The mean number of days practice was 23.1 (s.d. 15.7)...Compliance was also calculated as the percentage of times practised, where once per day would indicate 100% compliance; 24% of patients had a compliance of 76% or more, and there was a mean compliance of 68% s.d. 42.0, range 0‐200%).” |
|
| Outcomes | None included. | |
| Notes |
Funding: None acknowledged Unpublished data: Author provided information about randomisation and number of participants allocated. Unable to provide further information about outcomes. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “...were randomly allocated to one of four treatment conditions or to a waiting list control …” |
| Allocation concealment (selection bias) | Low risk | Independent, "i.e. not by me as I carried out the treatment" (personal communication) |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unclear if there was contact with researchers or providers. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=3 (15%) Comparison: N=0 (0%) Method of analysis: Unclear 4 dropouts, none from the wait‐list control group. Assumed dropout was equivalent across groups. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Groups were combined post‐hoc for analysis. None of the data can be extracted. |
| Other bias | Low risk | N/A |
Titov 2008a.
| Methods |
Location: Sydney, Australia Recruitment: Advertising/ Internet Exclusion rate: 68.47% Randomised (N): 105 (50 intervention; 55 comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); CIDI (DSM‐IV R) Duration (years): 23.6 Age (years): 38.13 Sex (female): 58.59% Race (white): 30.3% Medication (using at baseline): 30.3% Education (years): 13.01 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "had been taking the same dose for at least 1 month and did not intend to change that dose during the course of the programme (if taking medication for social phobia)" Drug/Alcohol: "not using illicit drugs or consuming more than three standard drinks/day" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Comparison description: The control group was asked to post a greeting to other participants in an online forum (to reduce attrition). Intervention name: Shyness Program (http://www.climateclinic.tv) Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=16 Provider contact: N=6 (125min) Contact description: Average 22 emails and responses on the forum (personal communication). "After completing each lesson participants were emailed by the therapist. The themes of the therapist’s emails varied from reinforcement for continued participation and efforts, encouragement to practise..." "It was estimated that the mean amount of therapist time per participant was 125 min (SD=25 min), including monitoring of the discussion forum and providing email...An additional average 25min per patient was required for administrative purposes..." Intervention description: “...six online lessons were based on the online social phobia lessons from the CLIMATEGP programme (www. climategp.tv)...illustrated story about a young man with social phobia...education...exposure hierarchy...cognitive restructuring...relapse prevention.” Compliance: Eleven "failed to complete all six lessons...two formally withdrew citing lack of time and motivation after experiencing a death or illness...exposure exercises were too anxiety provoking...did not find the programme helpful...overseas holiday; three cited a change in work or study...one reported complications due to her pregnancy and two did not give a reason. The mean number of lessons completed was 5.2...." 2 terminated at lesson 1, 3 at lesson 2, 4 at lesson 3, and 2 at lesson 4. |
|
| Outcomes |
Specific Symptoms: Social Interaction Anxiety Scale (SIAS) Depression: Patient Health Questionnaire (PHQ‐9) Disability: WHO Disability Assessment Schedule (WHODAS‐II) |
|
| Notes |
Funding: Faculty of Medicine, University of New South Wales Unpublished data: Titov provided details about baseline characteristics, allocation concealment, contact with participants and trial registration. Titov contacted a colleague who has GAD‐7 results, but data have not been provided. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “The 105 people accepted into the Shyness programme were randomized via a true randomization process (www.random.org)…” |
| Allocation concealment (selection bias) | Low risk | “We used a series of envelopes to conceal allocation from interviewers, and they were instructed to open each envelope only after a person they were interviewing had met criteria.” (personal communication) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) The themes of the therapist’s emails varied from reinforcement for continued participation and efforts, encouragement to practise "One clinical psychologist (NT) provided all clinical contact with participants." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=6 (10.91%) Method of analysis: LOCF 6 control participants dropped out before baseline measures were collected. "Post‐treatment data were collected from 93 participants (44/50 treatment group participants and 49/49 waitlist control group participants). In accordance with the intention‐to‐treat paradigm, the pre‐treatment scores of these six participants who did not complete the post‐treatment questionnaires were replicated as their post‐treatment scores." |
| Selective reporting (reporting bias) | High risk |
Trial registration number: ACTRN12607000235404 Outcomes are reported clearly except the GAD‐7. Subsequent reports include the combined GAD data for the intervention and control groups, but these could not be extracted for meta‐analysis. (See also the trial registration and personal communication.) |
| Other bias | Low risk | N/A |
Titov 2008b.
| Methods |
Location: Sydney, Australia Recruitment: Advertising/ Internet Exclusion rate: 68.57% Randomised (N): 88 (43 intervention; 45 comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); CIDI (DSM‐IV R) Duration (years): Unknown Age (years): 36.79 Sex (female): 62.96% Race (white): 25.93% Medication (using at baseline): 25.93% Education (years): 13.14 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "No significant changes were made either to the inclusion criteria, treatment procedure, or materials used in the original Shyness programme." Drug/Alcohol: "No significant changes were made either to the inclusion criteria, treatment procedure, or materials used in the original Shyness programme." Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Shyness Program (http://www.climateclinic.tv) Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=2.36 Provider contact: N=22.32 (126.76min) Contact description: The average therapist time per treatment group participant was 126.76 min (SD=30.89 min) including monitoring of the discussion forum and feedback. An additional average 25 min per patient was required for administrative purposes, including the diagnostic telephone interview. A review of email and forum contact showed that a total of 915 emails were sent to treatment group participants (mean=22.32, SD=4.06), with a mean of 2.36 (SD=2.06) forum postings in response to each participant’s posts (additional postings were made to the entire group). Intervention description: “The treatment programme was the same used in the original Shyness programme: six online lessons; homework assignments; participation in an online discussion forum; and regular email contact with a therapist.” Compliance: “Of these eight noncompleters, one said the programme was not helpful, and one reported they had improved sufficiently. The mean number of lessons completed was 5.5, and 33 participants completed all six lessons. The overall completion rate was 80%.” 2 terminated at lesson 1, 1 at lesson 3, and 2 at lesson 4, 3 at lesson 5. |
|
| Outcomes |
Specific Symptoms: Social Interaction Anxiety Scale (SIAS) Depression: Patient Health Questionnaire (PHQ‐9) Disability: WHO Disability Assessment Schedule (WHODAS‐II) |
|
| Notes |
Funding: Faculty of Medicine, University of New South Wales Unpublished data: Titov provided details about baseline characteristics, allocation concealment, contact with participants and trial registration. Titov contacted a colleague who has GAD‐7 results, but data have not been provided. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “The 88 people accepted into the programme were randomized via a true randomization process (www.random.org)...” |
| Allocation concealment (selection bias) | Low risk | “We used a series of envelopes to conceal allocation from interviewers, and they were instructed to open each envelope only after a person they were interviewing had met criteria.” (personal communication) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "The treatment programme was the same used in the original Shyness programme: six online lessons; homework assignments; participation in an online discussion forum; and regular email contact with a therapist." "One clinical psychologist (NT) provided all clinical contact with participants. A research assistant (GS) provided administrative support to collate data, follow progress and assist in the telephone interviews." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=5 (11.63%) Comparison: N=5 (11.11%) Method of analysis: LOCF “Although eight members of the treatment group did not complete all six lessons, post‐treatment data were collected from 78 participants (38/41 treatment group participants and 40/40 waitlist control group participants). In accordance with the intention‐to‐treat paradigm, the pre‐treatment scores of the three treatment group participants who did not complete the post‐treatment questionnaires were replicated as their post‐treatment scores.” |
| Selective reporting (reporting bias) | High risk |
Trial registration number: ACTRN12608000465358 Outcomes are reported clearly except the GAD‐7. Subsequent reports include the combined GAD data for the intervention and control groups, but these could not be extracted for meta‐analysis. (See also the trial registration and personal communication). |
| Other bias | Low risk | N/A |
Titov 2008c.
| Methods |
Location: Sydney, Australia Recruitment: Advertising/ Internet Exclusion rate: 40.24% Randomised (N): 98 (63 intervention; 35comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); MINI (DSM‐IV R) Duration (years): Unknown Age (years): 37.97 Sex (female): 61.05% Race (white): 21.74% Medication (using at baseline): 21.74% Education (years): 13.3 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "No significant changes were made either to the inclusion criteria or materials used in the previous Shyness programmes." Drug/Alcohol: "No significant changes were made either to the inclusion criteria or materials used in the previous Shyness programmes." Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Shyness Program (http://www.climateclinic.tv) Days of treatment: 70 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email & Phone Automated contact: N=Unknown Provider contact: N=18.32 (84min) Contact description: “per CaCCBT group participant was 168 min (SD=40min)...25 min per patient was required for administrative purposes, including the diagnostic telephone interview. A review of email contact showed that a total of 568 emails were sent to treatment group participants (mean=18.32, SD=4.84). Additional contacts included telephone calls to participants who were inactive...and regular responses to forum postings...“ Intervention description: Group 1 "received the usual Shyness treatment programme." Group 2 "received the Shyness treatment programme as described in the previous section, but without regular emails or forum responses from the therapist." Compliance: “The mean number of lessons completed was 5.39 (SD=1.31) and 3.97 (SD=1.87), for the CaCCBT and CCBT groups, respectively In the therapist‐assisted and no‐email intervention groups, 75% and 32% completed all lessons. There was a significant relationship between number of lessons completed and changes in SPS scores, events avoided, and events attended.” |
|
| Outcomes |
Specific Symptoms: Social Interaction Anxiety Scale (SIAS) Depression: Patient Health Questionnaire (PHQ‐9) Disability: Sheehan Disability Scale (SDS) |
|
| Notes |
Funding: None acknowledged Unpublished data: Titov provided details about baseline characteristics, allocation concealment, contact with participants and trial registration. Titov contacted a colleague who has GAD‐7 results, but data have not been provided. Two intervention groups differ in amount of contact. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “The 98 people accepted into the programme were randomized via a true randomization process (www.random.org)...” |
| Allocation concealment (selection bias) | Low risk | “We used a series of envelopes to conceal allocation from interviewers, and they were instructed to open each envelope only after a person they were interviewing had met criteria.” (personal communication) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) Two groups were combined for analysis. One group interacted with researcher/clinician (not blind) throughout the trial. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=2 (3.17%) Comparison: N=0 (0%) Method of analysis: LOCF “2 treatment and 1 control withdrew before beginning treatment." 4 "withdrew during the programme (two citing work commitments, one citing relationship breakdown, one citing death in the family), one did not complete, citing exam pressures, one did not complete, citing work commitments, and one could not be contacted. Of the non‐completers from the CCBT group one participant formally withdrew during the programme (citing work commitments), three did not complete, citing work commitments, 11 reported that they were unwilling to complete the exposure component of treatment independently, while five either could not be contacted..." "analyses involve an intention‐to‐treat (ITT) design." |
| Selective reporting (reporting bias) | High risk |
Trial registration number: ACTRN12608000192381 Outcomes are reported clearly except the GAD‐7. Subsequent reports include the combined GAD data for the intervention and control groups, but these could not be extracted for meta‐analysis. (See also the trial registration and personal communication). |
| Other bias | Low risk | N/A |
Titov 2009a.
| Methods |
Location: Sydney, Australia Recruitment: Advertising/ Internet Exclusion rate: 28.36% Randomised (N): 48 (25 intervention; 23comparison) |
|
| Participants |
Disorder: Generalised Anxiety Disorder; MINI (DSM‐IV R) Duration (years): Unknown Age (years): 44 Sex (female): 75.56% Race (white): 28.89% Medication (using at baseline): 28.89% Education (years): 13.52 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "if taking medication, had been taking the same dose for at least 1 month and did not intend to change that dose during the course of the programme." Drug/Alcohol: "not using illicit drugs or consuming more than three standard drinks day" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: The Worry Programme Days of treatment: 63 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email & Phone Automated contact: N=49.7 Provider contact: N=9.6 (130min) Contact description: “The mean total therapist time per treatment group participant was 130 min...additional average 30 min per patient was required for administrative purposes, including the diagnostic telephone interview. During the programme the software sent a total of 568 automatic emails to treatment group participants (mean=23.7 per participant), and the clinician sent 132 personal instant messages (mean=5.5 per participant). The clinician also made a total of 98 telephone calls (mean=4.1 telephone calls per participant) and made 26 forum postings to the entire group.’' Intervention description: “… six online lessons; a summary/homework assignment for each lesson…illustrated story about a woman with GAD…education…challenging positive and negative beliefs about excessive worry… graded exposure…challenging core beliefs… relapse prevention. Participants were encouraged to complete the first four lessons within the first 4 weeks, in order to provide more opportunity to practise the graded exposure…” Compliance: “That is, 75% of participants completed the programme…" 1 terminated at lesson 3, 5 terminated at lesson 5. |
|
| Outcomes |
Specific Symptoms: Generalised Anxiety Disorder Assessment (GAD 7) Response: Generalised Anxiety Disorder Assessment (GAD 7) Depression: Patient Health Questionnaire (PHQ‐9) Disability: Sheehan Disability Scale (SDS) |
|
| Notes |
Funding: Australian Rotary Health Research Fund Unpublished data: Titov provided unpublished manuscript, details about baseline characteristics, allocation concealment, contact with participants and trial registration. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “The 48 people accepted into the programme were randomized by NT via a true randomization process (www.random.org) to either the treatment (n=25) or control (n=23) groups (Table 1).” |
| Allocation concealment (selection bias) | Low risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) The mean total therapist time per treatment group participant was 130 min including monitoring of the discussion forum, instant messages, and telephone calls. "One clinical psychologist (ER) provided all clinical contact with participants." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=1 (4%) Comparison: N=2 (8.70%) Method of analysis: LOCF “Post‐treatment data were collected from 21/24 (88%) treatment group participants and 19/21 (90%) control group participants. In accordance with the ITT paradigm, the pre‐treatment scores of the five participants who did not complete the post‐treatment questionnaires were replicated as their post‐treatment scores.” |
| Selective reporting (reporting bias) | Low risk |
Trial registration number: ACTRN12609000136202 All outcomes reported. |
| Other bias | Low risk | N/A |
Titov 2010a.
| Methods |
Location: Sydney, Australia Recruitment: Advertising/ Internet Exclusion rate: 43.42% Randomised (N): 86 (42 intervention; 44 comparison) |
|
| Participants |
Disorder: Mixed (GAD, PD, SAD); MINI (DSM‐IV) Duration (years): Unknown Age (years): 39.5 Sex (female): 67.95% Race (white): 47.44% Medication (using at baseline): 47.44% Education (years): 13.15 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: Participants on medication were on a stable dose for 1 month. No benzodiazepines. Drug/Alcohol: No illicit drug use, no more than 3 drinks per day. Physical: N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Anxiety Program Days of treatment: 56 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email & Phone Automated contact: N=41.1 Provider contact: N=6 (46min) Contact description: “46 min (SD=16min) including monitoring of the discussion forum, sending and reading instant messages and telephoning participants. An additional average 30 min per participant was required for administrative purposes, including the diagnostic telephone interview." "treatment group participants received a total of 765 automatic emails (mean=19.1 per participant), with the clinician sending a mean of 4.5 additional personal instant messages per participant. The clinician also made a total of 215 telephone calls (mean = 5 per participant, and made 22 forum postings to the entire group” Intervention description: Six lessons, homework, online discussion forum, automatic emails, instant messaging with clinician. Psychoeducation, controlling physical symptoms lifestyle, principles of CBT, exposure, communication/assertiveness skills, relapse prevention. Participants encouraged to complete one each week, and to complete the six lessons within 8 weeks. Additional written resources. Illustrated stories about people who successfully begin to gain mastery over their symptoms. Compliance: Thirty (75%) treatment group participants completed the six lessons within the eight weeks of the program. "30 participants completed all 6 Lessons (1 withdrew at lesson 2, 2 withdrew at Lesson 4), 34 completed Lesson 5, 38 completed Lesson 4, 39 completed Lesson 3, and all participants completed Lessons 1 and 2." |
|
| Outcomes |
Specific Symptoms: Panic Disorder Severity Scale, self‐rated (PDSS‐SR); Penn State Worry Questionnaire (PSWQ); Social Phobia Screening Questionnaire (SPSQ) General Symptoms: Depression Anxiety Stress Scales ‐ 21 Item (DASS‐21) Depression: Patient Health Questionnaire (PHQ‐9) Disability: Sheehan Disability Scale (SDS) |
|
| Notes | Funding: Australian Rotary Health Research Fund; New South Wales Institute of Psychiatry | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “Eighty six applicants met all inclusion criteria and were randomized by NT via a true randomization process (www.random.org) to either the treatment (n=42) or control (n=44) groups (Table 1).” |
| Allocation concealment (selection bias) | Low risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) "One clinical psychologist (ER) provided all clinical contact with treatment group participants and another clinical psychologist (JS) provided all clinical contact with the control group....Therapists were encouraged to actively engage with participants in treatment..." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=2 (4.76%) Comparison: N=6 (13.63%) Method of analysis: LOCF Intervention (6 dropouts): 2 withdrew before the intervention began, 4 (observations carried forward) did not complete post‐treatment questionnaires. Control (8 dropouts): 5 withdrew before the program began, 1 did not complete pre‐treatment questionnaire, 2 (carried forward) did not complete post‐treatment questionnaires. "the pre‐treatment scores of participants who did not complete the post‐treatment or follow‐up questionnaires were replicated as their post‐treatment or follow‐up scores" (intention‐to‐treat) |
| Selective reporting (reporting bias) | High risk |
Trial registration number: ACTRN12609000501246 The MINI, BAI, SPS, SIAS, BVS, ACQ, and WHODAS‐II are not reported. The GAD‐7 and PSWQ are nor reported by group. |
| Other bias | Low risk | N/A |
Titov 2010a (GAD).
| Methods | As above. | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | |
| Allocation concealment (selection bias) | Low risk | |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | |
| Selective reporting (reporting bias) | High risk | |
| Other bias | Low risk | |
Titov 2010a (PD).
| Methods | See above. | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | |
| Allocation concealment (selection bias) | Low risk | |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | |
| Selective reporting (reporting bias) | High risk | |
| Other bias | Low risk | |
Titov 2010a (SAD).
| Methods | See above. | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | |
| Allocation concealment (selection bias) | Low risk | |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | |
| Selective reporting (reporting bias) | High risk | |
| Other bias | Low risk | |
Titov 2010b.
| Methods |
Location: Sydney, Australia Recruitment: Advertising/ Internet Exclusion rate: 13.74% Randomised (N): 113 (57 intervention; 56 comparison) |
|
| Participants |
Disorder: Social Anxiety (Unspecified); MINI (DSM‐IV) Duration (years): Unknown Age (years): 43.6 Sex (female): 47.22% Race (white): 15.74% Medication (using at baseline): 15.74% Education (years): 13.56 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "Change in medications during last 1 month or intended change during study duration." (protocol) Drug/Alcohol: "Current substance abuse/dependence" (protocol) Physical: N/A |
|
| Interventions |
Comparison group(s): Self‐help (CBT) Comparison description: The intervention was the same except for the reflective questions in the first 2 lessons. Intervention name: Shyness Program (http://www.climateclinic.tv) Days of treatment: 77 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=25 Provider contact: N=0 (0 min) Contact description: “Participants did not receive any contact with the researchers once the programme began, except for advice about browser connectivity. All participants received approximately 25 automatic email messages during the 11 week programme. These were triggered when they completed a lesson, to remind them to complete a lesson, or to inform them about materials that had become available." Intervention description: Six online lessons, illustrated story, education, graded exposure, cognitive restructuring, relapse prevention. Reflective questions about "costs and benefits of participating… values and how their symptoms affect attainment…reasons for participating, iv) how their life might be in five years if they didn’t participate…personal strengths… goals for participating, ii) obstacles…techniques they would use to overcome obstacles…personal strengths. " Compliance: Motivation group: "40 participants (75%) completed all lessons (1 terminated at Lesson 1, 1 terminated at Lesson 4, 2 at Lesson 6, 4 at Lesson 7, 5 at Lesson 8)" No‐contact group: 31 participants (56%) completed all lessons (1 terminated at Lesson 4, 1 at Lesson 5, 3 at Lesson 6, 5 at Lesson 7, 14 at Lesson 8) |
|
| Outcomes |
Specific Symptoms: Social Interaction Anxiety Scale (SIAS) Response: Social Interaction Anxiety Scale (SIAS) Depression: Patient Health Questionnaire (PHQ‐9) Disability: Sheehan Disability Scale (SDS) |
|
| Notes | Funding: None acknowledged | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “The 113 people accepted into the programme were randomized by NT via a true randomization process (www.random.org)…” |
| Allocation concealment (selection bias) | Low risk | Trial registration reports "Allocation concealment will occur by contacting the holder of the allocation schedule who is off‐site." |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | “Participants did not receive any contact with the researchers once the programme began, except for advice about browser connectivity.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=4 (7.018%) Comparison (other): N=1 (1.79%) Method of analysis: LOCF Analyses include those "Eligible for analysis (started Lesson 1)" "Reasons for participants not completing lessons or questionnaires were not available. In accordance with the ITT and LOCF models, missing data was replaced with the last observed score on that measure." |
| Selective reporting (reporting bias) | Low risk |
Trial registration number: ACTRN12609001082291 All outcomes reported. |
| Other bias | Low risk | N/A |
Tolin 2007.
| Methods |
Location: Hartford, CT, USA Recruitment: Referral Exclusion rate: 83.47% Randomised (N): 41 (20 intervention; 21 comparison) |
|
| Participants |
Disorder: OCD; SCID (DSM‐IV) Duration (years): 18.67 Age (years): 38.18 Sex (female): 36.59% Race (white): 56.1% Medication (using at baseline): 56.1% Education (years): 14.95 EXCLUSIONS Depression: No Psychotherapy: Current and previous therapy restricted Medication: "only if they could demonstrate a current or previous adequate trial of an SRI medication…the medication had to be maintained within the dose range typically used for OCD (see Tolin et al., 2004, for specific dose ranges) for at least 10 weeks…we confirmed with patients that they subjectively experienced no more than minimal effects…” Excluded those who "made any changes to psychiatric medications within 2 months of entering the study." Drug/Alcohol: "met criteria for a substance use disorder within the past 3 months" Physical: N/A |
|
| Interventions |
Comparison group(s): Individual CBT Comparison description: “Treatment was provided by an experienced doctoral‐level psychologist or postdoctoral fellow. ERP was based on a published manual (Foa and Kozak, 1997b)… Patients received 15 sessions, delivered twice weekly over 7 1/2 weeks. ERP treatment consisted of the following components: Information gathering and treatment planning…Exposure and response prevention…Relapse prevention…” Other CBT interventions allowed as needed. Intervention name: Stop Obsessing! (Foa and Wilson, 2001). Days of treatment: 42 Author wrote: No Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: "following the pretreatment independent evaluation, patients in the self‐administered ERP condition met with a study clinician. The clinician provided the patient with a brief overview of this treatment condition, including the instruction that they would be expected to conduct ERP exercises on their own...no further planned contact with the therapist for the next 6 weeks, although they were encouraged to contact the therapist in case of emergency or acute worsening of symptoms." Intervention description: ERP: “the book begins with a general orientation, psychoeducation, and a motivational discussion; next, rationale and instructions for ERP are provided; finally (and for the bulk of the program), patients are led through specific ERP exercises aimed to reduce obsessive thoughts and compulsive behaviors. Patients were instructed to read the book and follow its instructions over a 6‐week period, and were given a written schedule of suggested chapters to read during each of the 6 weeks.” Compliance: “At the end of the 6‐week period, patients met again with the therapist to review their experiences with self‐administered ERP. The therapist queried the patient about whether they read the entire book, the frequency and duration of exposure exercises, and the degree of abstinence from compulsive behaviors.” |
|
| Outcomes |
Specific Symptoms: Clinical Global Impression (CGI): Severity General Symptoms: State‐Trait Anxiety Inventory (STAI): Trait Response: Clinical Global Impression (CGI): Improvement; Yale‐Brown Obsessive‐Compulsive Scale (Y‐BOCS) Depression: Beck Depression Inventory (BDI); Hamilton Depression Rating Scale, clinician‐rated (HAM‐D) Disability: Sheehan Disability Scale (SDS) Quality of Life: Quality of Life Inventory (QOLI) |
|
| Notes |
Funding: Patrick and Catherine Weldon Donaghue Medical Research Foundation Unpublished data: Author provided demographic details and outcome data. While the published data are analysed using ITT, the data provided are for available cases. The ITT data were used for analysis. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “Patients were then randomly assigned to receive either therapist‐administered ERP or self‐administered ERP according to a computerized random allocation table.” |
| Allocation concealment (selection bias) | Low risk | “Administered by a research assistant and not available to other members of the research team.” Assessment conducted by a blind rater. (personal communication) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Control group "received 15 sessions, delivered twice weekly over 7.5 weeks. ERP treatment consisted of the following components" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) the therapists, who were not blind to treatment condition or to treatment outcome, assigned effort ratings. "independent evaluator who was unaware of treatment condition conducted all clinical assessments at pretreatment, posttreatment and 10, 3‐, and 6‐month follow‐up" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=3 (15%) Comparison: N=4 (19.05%) Method of analysis: Available Case “Participants who changed their medication (contrary to instructions) were included in the analyses. One participant went to the emergency room with 'hyperventilation syndrome'. The participant was discontinued from the study and last observations were carried forward. Most outcomes are not reported in the published paper, which reports data using LOCF. Data from the author are available cases; ITT analyses used when both were available (YBOCS).” |
| Selective reporting (reporting bias) | Low risk |
Trial registration number: NCT00316355 Not all outcomes included in paper; unpublished data received from the authors, though analysed using available cases. |
| Other bias | Low risk | N/A |
Tolin 2011.
| Methods |
Location: Connecticut, USA Recruitment: Unclear Exclusion rate: 85.65% Randomised (N): 34 (19 intervention; 15 comparison) |
|
| Participants |
Disorder: OCD; ADIS (DSM‐IV) Duration (years): N/A Age (years): 33.91 Sex (female): 58.82% Race (white): 47.06% Medication (using at baseline): 47.06% Education (years): N/A EXCLUSIONS Depression: Yes Psychotherapy: Current and previous therapy restricted Medication: "Participants who were taking psychiatric medications were stable on medication for at least 1 month and agreed to maintain their current type and dose of medication, with their physician’s approval." Drug/Alcohol: "substance abuse/dependence" Physical: N/A |
|
| Interventions |
Comparison group(s): Individual CBT Comparison description: “…17 outpatient treatment sessions lasting 90–120 min each. Treatment began with information gathering and treatment planning, during which the patient’s symptoms were assessed in detail and an exposure hierarchy was created. ERP was then provided twice weekly… consisted of graded exposure to the items on the hierarchy, combined with strict abstinence from compulsive behavior. In the final session, relapse prevention was reviewed…” Intervention name: Stop Obsessing! (Foa and Wilson, 2001). Days of treatment: 42 Author wrote: No Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=3 (105 min) Contact description: “During step 1, participants also met with the therapist three times (one 30–40 min visit every 2 weeks). The therapist’s function was to provide support and examine sources of life stress. In addition, the therapist used motivational interviewing techniques to address ambivalence about change. The therapist answered questions regarding ERP, and provided suggestions for implementing ERP; however, no ERP was performed or modeled within these sessions.” Intervention description: “...three sections: Understanding Your Problem, The Initial Self‐Help Program, and The Intensive Three‐Week Program (which focuses on ERP). Based on our experience in the open trials, we organized the reading schedule to emphasize self‐administered ERP." Compliance: N/A |
|
| Outcomes | None included. | |
| Notes | Funding: National Institute of Mental Health. Grant R34 MH071464 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “randomized to receive stepped care or standard ERP” |
| Allocation concealment (selection bias) | Low risk | “Patients meeting study inclusion criteria were then referred to a study therapist, who informed the patient of their randomly assigned treatment condition.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “During step 1, participants also met with the therapist three times (one 30–40 min visit every 2 weeks). The therapist’s function was to provide support…” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomesincluded in this review. (See Selective Outcome Reporting.) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: Mixed effects Only data on clinical response were analysed. |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Data are presented after "Step 2" when participants receiving self‐help had received face‐to‐face therapy if they did not improve. For that time point, means and SDs are reported for the YBOCS but for none of the other outcome measures. |
| Other bias | Low risk | N/A |
Tortella‐Feliu 2011.
| Methods |
Location: Mallorca, Spain Recruitment: Advertising/ Internet Exclusion rate: 30.23% Randomised (N): 60 (21 intervention; 20comparison) |
|
| Participants |
Disorder: Specific Phobia; ADIS (DSM‐IV) Duration (years): 3.97 Age (years): 37.1 Sex (female): 60.98% Race (white): 0% Medication (using at baseline): 0% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "taking anxiolytic or antidepressive medication" Drug/Alcohol: N/A Physical: "cardiovascular or respiratory illness, and current pregnancy" |
|
| Interventions |
Comparison group(s): Self‐help (Exposure) Comparison description: “…buying a ticket, packing at home, going to the airport and boarding, taking off, flying, landing, and hearing news about an aircraft accident. At the end of each sequence, the program requested fear ratings; based on the replies, the exposure continued with the same sequence or proceeded to the next sequence in the hierarchy…Therapists attended all CAE‐T sessions...If patients asked about the treatment process, they were invited to utilize the program’s online help system.” Intervention name: Not named Days of treatment: 21 Author wrote: Yes Type of media: Computer Type of therapy: Exposure Location used: Clinic/ Surgery Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=2 (30min) Contact description: The first exposure trials were begun with a therapist present, to make sure the patients had completely understood the instructions. "At the last session, each patient had a personal 20‐min meeting with a therapist." Intervention description: “essentially self‐administered …The first exposure trials were begun with a therapist present, to make sure the patients had completely understood the instructions. Then, the therapist left the clinic while the user was exposed to images and sounds. In the following sessions, the user simply asked the receptionist for access to the session room. At the last session, each patient had a personal 20‐min meeting with a therapist.” Compliance: “The mean number of sessions for each treatment was M = 4.70 (SD = 1.34) in the CAE‐T [control], M = 4.10 (SD = 1.51) in the CAE‐SA [intervention]…” |
|
| Outcomes |
Specific Symptoms: Anxiety Disorders Interview Schedule (ADIS‐IV): Specific Phobia, Avoidance Behaviour Test (Level): Flights Taken Response: Fear of Flying Questionnaire (FFQ) Recovery: No longer met criteria for diagnosis |
|
| Notes | Funding: Grants SEJ2005‐ 00899/PSIC, SEJ‐2006‐14301/PSIC, PROMETEO/2008/157, and CIBER Fisio‐ patologia de la Obesidad y Nutricion—ISCIII CB06/03/0052 from the Spanish Government. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Method: Unclear “Suitable candidates for treatment (n = 60) were randomized to one of the three treatment conditions” |
| Allocation concealment (selection bias) | Unclear risk | “All the assessments were carried out by independent evaluators who were not involved in the randomization process.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “The first exposure trials were begun with a therapist present…” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “independent assessors rated, both at baseline and at posttreatment…" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison (other): N=0 (0%) Method of analysis: LOCF “Analyses included an intent‐to‐treat (ITT) using the last value carried forward (LVCF) method. Missing values at posttreatment and/or at 1‐year follow‐up were imputed with the participant’s pretreatment score.” |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Tyrer 1988.
| Methods |
Location: Nottingham, England Recruitment: Referral Exclusion rate: 5.41% Randomised (N): 154 (42 intervention; 28, 84 comparison) |
|
| Participants |
Disorder: Mixed (9% had GAD or PD ); SCID (DSM III) Duration (years): Unknown Age (years): 35 Sex (female): 69.05% Race (white): 0% Medication (using at baseline): 0% Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: No restrictions reported Medication: "They were currently receiving no psychotropic drugs (and had not been taking benzodiazepines, neuroleptic drugs, or antidepressants in regular dosage for at least 4 weeks before entry to the study)" Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Pill placebo, Individual CBT Comparison description: 1) Pill placebo. 2) "Patients receiving cognitive and behaviour therapy had five one‐hour treatments at 0, 1, 2, 4, and 6 weeks after randomisation" Intervention name: Not named Days of treatment: 42 Author wrote: Yes Type of media: Audio Type of therapy: Muscle Relaxation Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=5 (75min) Contact description: "saw the same team of community nurses at the same treatment intervals, but on each occasion were seen for 15 minutes only" At weeks 0, 1, 2, 4 and 6 for 15 minutes (5 sessions). Intervention description: “given a relaxation tape without any specific training, and given a list of self‐help organisations and groups for people with anxiety and depression. Patients in this group were told initially that drugs were potentially dangerous because of dependence and that individual psychotherapy could lead to similar dependence on a therapist, therefore it was wise to avoid these where possible and to work out one’s own treatment programme...completed after these five sessions.” Compliance: Pill counts for the medication group. |
|
| Outcomes | None included. | |
| Notes |
Funding: Trent Regional Health Authority, Jessie Spencer Trust, Boots Pure Drug Company (which provided diazepam, dothiepin and placebo capsules). Unpublished data: Emailed Tyrer for further information, but the author did not reply. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Unclear “A randomised parallel‐group design” (See “Allocation Concealment”) |
| Allocation concealment (selection bias) | Low risk | “The randomised treatments were indicated by opening a sealed envelope once patients satisfied the inclusion criteria for the study.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “seen at weeks 0, 1, 2, 4 and 6 for 15 minutes.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “All trained psychiatrists were masked with respect to treatment and diagnosis” |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk |
Not analysed at post‐treatment Intervention: N=4 (9.52%) Comparison (pill placebo): N=2 (7.14%) Comparison (individual CBT): N=7 (8.33%) Method of analysis: Available Case 18 dropped‐out, though the two‐year follow‐up paper lists only 2 dropouts in Table 2 (1 from the drug/placebo group; 1 CBT). 4 patients had no baseline ratings and 5 provided only baseline measures. Assumed equal dropout between groups. "The 17 missing ratings were estimated statistically be equating residuals to zero in a repeated measures ANOVA and the residual and to degrees of freedom reduced by 17" |
| Selective reporting (reporting bias) | High risk | No trial registration number given. “The main outcomes are not reported in a manner that can be extracted for meta‐analysis.” |
| Other bias | Low risk | N/A |
van Boeijen 2005a.
| Methods |
Location: Rural and urban areas, Holland Recruitment: Referral Exclusion rate: 46.34% Randomised (N): 154 (59 intervention; 28, 67 comparison) |
|
| Participants |
Disorder: Mixed (GAD, PD); SCID (DSM‐IV) Duration (years): 8.75 Age (years): 38.8 Sex (female): 62.68% Race (white): 28.87% Medication (using at baseline): 28.87% Education (years): 12.73 EXCLUSIONS Depression: No Psychotherapy: Current and previous therapy restricted Medication: "use of antidepressants or the use of more than 30 mg oxazepam equivalents daily" Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): Treatment‐as‐usual, Individual CBT Comparison description: 1) The Netherlands College of General Practitioners Anxiety Disorder Guidelines implemented by a GP. "GP was free to choose the number of sessions and the type of intervention...relaxation exercises or psychiatric treatment and to prescribe antidepressants or benzodiazepines." 2) "12 45‐minute sessions. The participants practiced for 3 hours a week. They received a CBT handbook explaining the basic facts about anxiety and the rationale of CBT" Intervention name: Not named Days of treatment: 84 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=5 (100 min) Contact description: “Self‐help treatment consisted of five 20–minute sessions. In the first session, the GP informed the participant about the contents of the manual, which comprised an explanation of the basic facts about anxiety, simple cognitive techniques, and relaxation and in vivo exposure exercises. The participants put the self‐help techniques learnt from the manual into practice for 3 hours a week. In subsequent sessions, the GP reinforced the patient’s achievements and motivated him or her to continue with the use of the manual.” Intervention description: “12 weeks based on cognitive‐behavioural principles.” Compliance: “the GP reinforced the patient’s achievements and motivated him or her to continue with the use of the manual.” |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ) General Symptoms: Lehrer Woolfolk Anxiety Symptom Questionnaire (LWASQ); State‐Trait Anxiety Inventory (STAI) Depression: Beck Depression Inventory (BDI) Disability: Sheehan Disability Scale (SDS) |
|
| Notes |
Funding: Naderlandse Organisatie voor Wetenschappelijk Onderzoek Unpublished data: van Boeijen provided data about participant characteristics and treatment provided by GPs. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “The participating practices (n=46) were first randomly assigned in a ratio of 1:1 to ‘manual’ or ‘guidelines’ as a primary care method. Next, within each practice, patients were randomly assigned to primary or secondary care in a ratio of 2:1. For both randomisations a computerised randomisation scheme was used. Randomisation ratio changed halfway through the trial.” |
| Allocation concealment (selection bias) | Low risk | "In both randomisation procedures (primary care practices and participants) the assignments were put in sequentially numbered, sealed, opaque envelopes by an independent statistician. At the start of the study the first author opened the envelopes for the participating practices. During the study the first author opened the envelopes after participants had given their informed consent." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “Self‐help treatment consisted of five 20–minute sessions.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison (treatment‐as‐usual): N=2 (7.14%) Comparison (individual CBT): N=4 (5.97%) Method of analysis: LOCF “no significant differences were found between dropouts and completers at pre‐test” 12 drop‐outs in self‐help group at post‐test, 13 drop‐outs in CBT treatment at post‐test, 4 drop‐outs in TaU group at post‐test. 24 dropouts in self‐help group at follow‐up, 14 drop‐outs in CBT at follow‐up, 7 drop‐outs in TaU at follow‐up." |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | High risk | GPs felt unable to conduct CBT for TaU condition. "practices randomly assigned to ‘manual’ treatment had on average twice as many patients as those assigned to ‘guidelines’. As a consequence, there was an unintended difference in size between the three study groups. Having consulted an independent statistician, the authors decided halfway through the study to change the primary care: secondary care randomisation ratio in the practices offering ‘manual'" |
Varley 2011.
| Methods |
Location: Sheffield, England Recruitment: Advertising/ Internet Exclusion rate: 98.95% Randomised (N): 262 (176 intervention; 86 comparison) |
|
| Participants |
Disorder: Mixed (not specified); No diagnostic interview (questionnaire only) Duration (years): Unknown Age (years): 29.65 Sex (female): 72.19% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: No Psychotherapy: Current restricted, no previous restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: N/A |
|
| Interventions |
Comparison group(s): No‐Treatment Comparison description: “participants in the control condition did not receive any intervention” Intervention name: Feeling Less Worried: A Three‐Step Plan to Help You Manage Your Anxiety Days of treatment: 56 Author wrote: Yes Type of media: Internet Type of therapy: Relaxation Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: "following the baseline questionnaire, participants downloaded the booklets online. The next contact that they received from the research team was eight‐weeks later when they received an email request to complete a folow‐up questionnaire." (personal communication) Intervention description: “eight pages long and included psychoeducation…diary sheets…two relaxation techniques…a short breathing exercise that could be undertaken whenever it was needed…a longer, deep muscle relaxation…” "participants in the augmented self‐help condition received the same booklet but also additional materials that asked them to form an implementation intention specifying when they would use the techniques...taken to a Web page where they could download..." Compliance: Frequency of strategy use was measured by three items (5‐point scales ranging from never to once or more a day) Standard=3.02, Augmented 3.65. |
|
| Outcomes |
General Symptoms: Hospital Anxiety and Depression Scale (HADS): Anxiety Depression: Hospital Anxiety and Depression Scale (HADS): Depression |
|
| Notes |
Funding: ESRC. "The contributions of Thomas L. Webb and Paschal Sheeran were supported by ESRC grant RES‐060‐25‐0044: Emotion regulation of others and self (EROS)." Unpublished data: "Conducted as part of a DClinPsy student's (Rachel Varley) thesis work. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “randomly allocated via an html program to one of three conditions (participants were unaware of the randomization procedure)” |
| Allocation concealment (selection bias) | Low risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | No provider contact. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=5 (2.84%) Comparison: N=8 (9.30%) Method of analysis: Available Case See Figure 1. 249 of 262 (95%) analysed |
| Selective reporting (reporting bias) | Unclear risk | "No, we did not register the trial." (personal communication) |
| Other bias | Low risk | N/A |
Walker 2001.
| Methods |
Location: Winnipeg, Canada Recruitment: Advertising/ Internet Exclusion rate: Unknown Randomised (N): 128 (32 intervention; 32, 32 comparison) |
|
| Participants |
Disorder: Social Anxiety (General); SCID (DSM‐IV) Duration (years): Unknown Age (years): 37.73 Sex (female): 60.27% Race (white): Unknown Medication (using at baseline): Unknown Education (years): 13.84 EXCLUSIONS Depression: Yes Psychotherapy: No restrictions reported Medication: "Individuals who were taking psychiatric medication (most often low dose benzodiazepines or SSRI antidepressants) were allowed to participate providing that they had been on a stable dose of medication for the previous 3 months and that the symptoms were sufficient in severity…" Drug/Alcohol: "substance abuse" Physical: N/A |
|
| Interventions |
Comparison group(s): Wait list, Group CBT Comparison description: 1) Wait‐list. 2) Group therapy: participants attended weekly group meetings lead by a psychologist or a senior psychology graduate student experienced in CBT of anxiety disorders. Participants received the self‐help materials. Intervention name: Dying of Embarrassment (Markway, Carmin, Pollard, and Flynn, 1992). Audiotape "Letting Go of Stress". Days of treatment: 71 Author wrote: No Type of media: Mixed Type of therapy: CBT Location used: Anywhere Type of contact: None Automated contact: N=0 Provider contact: N=0 (0 min) Contact description: “Individuals who called in response to the advertisement were screened over the telephone. Those who seemed likely after the screening…were seen for a SCID with clinician." No therapist contact during the thirteen week treatment period in self‐administered treatment condition. Intervention description: Book CBT. Workbook emphasised putting reading into practice. All groups used the same book, workbook and relaxation tape. The group therapy conditions used the same therapist manual. Treatment duration unclear (described as 12, 13 and 14 weeks on the same page). Compliance: Weekly time logs were returned by post. The author reports that some participants completed few assignments "preferring to wait for the opportunity to participate in the group program which came at the end of the study.” |
|
| Outcomes | Response: Clinical Global Impression (CGI): Improvement | |
| Notes |
Funding: Authors report that the program was developed with the Anxiety Disorders Association of Manitoba, a consumer‐run self‐help association, and they acknowledge the Medical Research Council. Unpublished data: Author provided details about randomisation process and sent presentations with outcome data. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Mechanical Generated and administered by drawing names from a hat (personal communication). "Individuals accepted in the study were accumulated into blocks of eight. When a block has been assembled, participants in that block were randomly assigned to one of four treatment conditions." |
| Allocation concealment (selection bias) | High risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | “Participants used the treatment program in a self‐administered format with no therapist contact during the thirteen week treatment period.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Included assessor‐rated outcomes (blind) “independent assessor remained blind to the group assignment of the participants” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=3 (9.375%) Comparison (wait‐list): N=3 (9.375%) Comparison (group CBT): N=4 (12.5%) Method of analysis: Available Case “a number of respondents (less than 10%) were lost to follow up when they dropped out of the study” |
| Selective reporting (reporting bias) | High risk | No trial registration number given. Clinical global impression scores are reported as a bar graph and could not be extracted. For continuous measures, variance is missing and most data could not be included in meta‐analysis for: Social Anxiety and Distress Scale (SADS), Social Phobia Scale (SPS), Social Phobia Anxiety Inventory (SPAI), Social Interaction Anxiety Scale (SIAS), Fear of Negative Evaluation Scale (FNE), Fear Questionnaire (FQ): Social Phobia, Clinical Global Impression (CGI): Severity. |
| Other bias | Unclear risk | N/A |
White 1995.
| Methods |
Location: Glasgow, UK, Scotland Recruitment: Referral Exclusion rate: 36.08% Randomised (N): 62 (21 intervention; 20comparison) |
|
| Participants |
Disorder: Mixed (any anxiety disorder); ADIS (DSM‐III R) Duration (years): 3 Age (years): 38.95 Sex (female): 58.54% Race (white): 58.54% Medication (using at baseline): 58.54% Education (years): 12.3 EXCLUSIONS Depression: No Psychotherapy: Current and previous therapy restricted Medication: "no recent change in psychotropic medication" Drug/Alcohol: "no evidence of…alcohol or drug problems" Physical: N/A |
|
| Interventions |
Comparison group(s): Attention/Monitoring Comparison description: Advice Only: "The procedure for AO was the same as for SP, except that in the final 30 minutes patients were offered specific verbal advice on ways of coping, while on the waiting list, with specific problems elicited during assessment e.g. noting the importance of exposure, the value of setting aside time to relax, the value of challenging negative thinking etc. No written or taped material was offered. As with SP patients, they were given an appointment time in three months." Intervention name: Stresspac Days of treatment: 91 Author wrote: Yes Type of media: Book / Booklet Type of therapy: CBT Location used: Anywhere Type of contact: Face‐to‐face Automated contact: N=0 Provider contact: N=2 (30min) Contact description: All patients were given a two hour initial interview. This principally involved the ADIS‐R assessment. The Hamilton Scales were omitted. This took, on average, 90 minutes. The remaining 30 minutes varied across conditions (see below). "Following ADIS‐R, 30 minutes were given to describing Stresspac and how to use it. " Intervention description: “...79 page booklet, a four page introduction and a double‐sided progressive relaxation tape ('Deep' and 'Rapid)…'Controlling your body'...'Controlling your thoughts'...'Controlling your actions' which emphasizes the importance of exposure and offers other behavioural advice. 'Controlling your future' (relapse prevention) ends the treatment section. Flesch reading formula scores (Flesch, 1948) for the booklet are 73 ('fairly easy').” Compliance: Not reported. |
|
| Outcomes |
Specific Symptoms: Anxiety Disorders Interview Schedule (ADIS‐IV): Global Severity General Symptoms: Hospital Anxiety and Depression Scale (HADS): Anxiety Response: Global Improvement Depression: Hospital Anxiety and Depression Scale (HADS): Depression |
|
| Notes |
Funding: Lanarkshire Health Board Unpublished data: See "Sequence Generation" |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk |
Method: Unclear “The remaining 62 patients were randomly allocated" Author says it was "alternating" (personal communication) |
| Allocation concealment (selection bias) | Unclear risk | N/A |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “author carried out all assessments and treatments” |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Included assessor‐rated outcomes (NOT blind) “author carried out all assessments and treatments” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=0 (0%) Comparison: N=0 (0%) Method of analysis: Imputed “There was very little missing data (<5%). Where necessary, a mean score was substituted (Winer, 1962).” |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Wims 2010.
| Methods |
Location: Sydney, Australia Recruitment: Advertising/ Internet Exclusion rate: 42.16% Randomised (N): 59 (32 intervention; 27comparison) |
|
| Participants |
Disorder: Panic disorder; MINI (DSM‐IV) Duration (years): Unknown Age (years): 42.08 Sex (female): 75.93% Race (white): 38.89% Medication (using at baseline): 38.89% Education (years): 13.63 EXCLUSIONS Depression: Yes Psychotherapy: Current restricted, no previous restrictions reported Medication: "if taking medication, had been taking the same dose for at least 1 month and did not intend to change that dose during the course of the program; (viii) and were not taking benzodiazepines." Drug/Alcohol: "not using illicit drugs or consuming more than three standard drinks/day" Physical:N/A |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: The Panic Program Days of treatment: 56 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=41 Provider contact: N=7.5 (75min) Contact description: “Participants who had not logged into the program for 2 weeks and had not returned emails were telephoned... "The mean therapist time per participant was 75 minutes including monitoring of the discussion forum and feedback. An additional average 60 minutes per patient was required for administrative purposes....A review of email and forum contact showed that a total of 218 emails were sent to treatment group participants (mean=7.5 emails per participant), with 41 forum postings made to the entire group by the therapist." Intervention description: “...four components: six online lessons, homework assignments…illustrated story about a woman with panic and agoraphobia who, with the help of a therapist, learn show to gain mastery over her symptoms…psychoeducation, graded exposure, cognitive restructuring, physiological de‐arousal, and relapse prevention.” "...complete the first three lessons within a week...Thereafter they were given access to the following lessons at fortnightly intervals" Compliance: “Twenty‐three members of the treatment group (79%) completed all six lessons within the required time frame.” |
|
| Outcomes |
Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ) Response: Panic Disorder Severity Scale (PDSS) Recovery: No longer met criteria for diagnosis Depression: Patient Health Questionnaire (PHQ‐9) Disability: Sheehan Disability Scale (SDS) |
|
| Notes | Funding: None acknowledged | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Computer/Online “The 59 people accepted into the program were randomized via a true randomization process (www.random.org)” |
| Allocation concealment (selection bias) | Low risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) '"One psychiatry registrar (EW) provided all clinical contact with participants. A research assistant provided administrative support to collate data." "After completing each lesson participants were emailed by the therapist...reinforcement for continued participation and efforts, encouragement to practice..." |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Included assessor‐rated outcomes (blinding unclear) “Participants were also telephoned by the clinician who administered the Panic Disorder Severity Scale, which also provided estimates of the frequency of panic attacks." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Not analysed at post‐treatment Intervention: N=3 (9.38%) Comparison: N=2 (7.41%) Method of analysis: LOCF In accordance with the intention‐to‐treat paradigm, the pre‐treatment scores of the participants who did not complete the post‐treatment questionnaires were replicated as their post‐treatment scores. Participants who dropped out before lesson 1 and before completing pre‐treatment questionnaires were excluded. "Two participants found the program required more time than they were able to set aside, one person dropped out due to increased severity of their anxiety which required inpatient admission, another became ill, another found the course too difficult and the final participant moved house during the program and no longer had internet access." |
| Selective reporting (reporting bias) | Low risk |
Trial registration number: ACTRN12608000548336 All outcomes reported. |
| Other bias | Low risk | N/A |
Zetterqvist 2003.
| Methods |
Location: Uppsala, Sweden Recruitment: Advertising/ Internet Exclusion rate: 39.02% Randomised (N): 100 (50 intervention; 50comparison) |
|
| Participants |
Disorder: Mixed (m ean HADS Anxiety score in the moderate to severe range (i.e. mean >13).); No diagnostic interview (questionnaire only) Duration (years): Unknown Age (years): 39.17 Sex (female): 61.9% Race (white): Unknown Medication (using at baseline): Unknown Education (years): Unknown EXCLUSIONS Depression: Yes Psychotherapy: No restrictions reported Medication: N/A Drug/Alcohol: N/A Physical: "if they perceived that they had any obstacles that prevented them from completing the study (including medical, social and psychological reasons)" |
|
| Interventions |
Comparison group(s): Wait‐List Intervention name: Not named (Similar to interventions by Andersson and Carlbring) Days of treatment: 91 Author wrote: Yes Type of media: Internet Type of therapy: CBT Location used: Anywhere Type of contact: Email Automated contact: N=0 Provider contact: N=6 (duration unknown) Contact description: “Participants registered the frequency and duration of practising relaxation in a diary and results were reported once each week. The rationale for this registration was mainly to keep regular contact with the participants, thereby promoting compliance. Duration of contact with participants not measured (personal communication), if two weeks passed without a report, participants were contacted by the researchers by email.” Intervention description: “6 treatment modules were each divided into the 3 sections: relaxation, additional exercises and information…problem‐solving module presented step‐by‐step instructions with illustrating examples…time management exercise...cognitive and behavioural restructuring exercise...Techniques for analysing and changing negative automatic thoughts and stress enhancing behaviours were also presented...” "The actual treatment for the self‐help group started in late April 2000 and ended in June/July" Compliance: Participants registered the frequency and duration of practising relaxation in a diary and results were reported once each week. The rationale for this registration was mainly to keep regular contact with the participants, thereby promoting compliance. "At the time of the post‐treatment data collection the self‐help group had completed an average of 4.2 out of the 6 treatment modules. Twelve participants completed all homework assignments and treatment modules." |
|
| Outcomes |
General Symptoms: Hospital Anxiety and Depression Scale (HADS): Anxiety Depression: Hospital Anxiety and Depression Scale (HADS): Depression |
|
| Notes |
Funding: Swedish Council for Social Research Unpublished data: Authors provided details about randomisation and concealment. Unable to provide baseline data or outcome data. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Method: Mechanical “assigned randomly to one of two conditions” Participants were assigned by coin toss (personal communication). |
| Allocation concealment (selection bias) | High risk | See “Sequence Generation” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Included contact with researcher/clinician (not blind) “They were given the option to use a coded e‐mail identity for contact with the project leaders. None of the participants used this alternative. All contact with the participants was conducted through e‐mail.” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No assessor‐rated outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | High risk |
Not analysed at post‐treatment Intervention: N=27 (54%) Comparison: N=10 (20%) Method of analysis: Available Case “3 participants in the control group and 12 in the self‐help group declared that they were no longer interested and withdrew before the study proper had started. Hence, the actual number of participants was 85, who by then already had been randomized to each respective condition. Of the participants, 26% (15 in the treatment group and 7 in the control group) dropped out at various stages without providing follow‐up data, leaving a final sample of 63 participants (23 in the self‐help condition and 40 in the waiting list condition)” Authors report that an ITT analysis was not significant for the perceived stress scale, but data presented include 63 of 85 participants. |
| Selective reporting (reporting bias) | Unclear risk | No trial registration number given. |
| Other bias | Low risk | N/A |
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
|---|---|
| Allen 1973 | Participants not clinically anxious (test anxiety) |
| Altmaier 1981 | Participants not clinically anxious (test anxiety) |
| Andersson 2006 | No eligible comparison (contact varied). The intervention included two 3‐hour group exposure sessions that were not common to both groups. |
| Arpin‐Cribbie 2008 | Participants not clinically anxious (perfectionism) |
| Ayres 1993 | Participants not clinically anxious (public speaking) |
| Bennett 1985 | Not BT/CBT (educational only) |
| Berger 2011 | No eligible comparison (contact varied) |
| Billings 2008 | Participants not clinically anxious (stress) |
| Boettcher 2012 | Not BT/CBT (attention training) |
| Bornas 2001 | Not stand‐alone (virtual reality) |
| Botella 1999 | No eligible comparison (contact varied) |
| Carpenter 1994 | Participants not clinically anxious (dental anxiety) |
| Chiauzzi 2008 | Participants not clinically anxious (stress) |
| Coldwell 1998 | Participants not clinically anxious (dental anxiety) |
| Cronin 1994 | Participants not clinically anxious (public speaking) |
| Crowder 1970 | Not BT/CBT (book about snakes) |
| Currie 2010 | Not a RCT |
| Dannon 2002 | Not BT/CBT (educational only) |
| den Boer 2007 | Not stand‐alone (self‐help groups) |
| Devine 1973 | No eligible comparison (preferred versus not preferred therapy) |
| Dolezal‐Wood 1998 | Not stand‐alone (computer assisted therapy) |
| Donner 1969 | Participants not clinically anxious (test anxiety) |
| Furmark 2009 | No eligible comparison (contact varied) |
| Gatchel 1986 | Participants not clinically anxious (dental anxiety) |
| Gross 1979 | Participants not clinically anxious (specific fear). "undergraduated served as Ss. All were enrolled in the introductory psychology classes and were given credit for participating in the study. Ss were selected on the basis of their behavioral responses in the presence of five live rats." |
| Grossman 1991 | Participants not clinically anxious (dating anxiety) |
| Gruber 2001 | No eligible comparison (contact varied) |
| Halpern 1995 | Participants not clinically anxious (college volunteers) |
| Hamberger 1986 | Participants not clinically anxious (public speaking) |
| Hasson 2005 | Participants not clinically anxious (stress) |
| Hasson 2010 | Participants not clinically anxious (stress) |
| Hazen 2009 | Not BT/CBT (attention training) |
| Heatherton 2004 | Trial discontinued |
| Hecker 2004 | No eligible comparison (contact varied) |
| Hetherton 2004 | Trial discontinued |
| Hickie 2010 | Participants not clinically anxious (psychological distress) |
| Hiebert 1983 | Participants not clinically anxious (stress) |
| Hoek 2012 | Participants <18 years |
| Hogan 1968 | Not BT/CBT (book about snakes) |
| Hopf 1995 | Not BT/CBT (for group leaders) |
| Israel 1977 | Participants not clinically anxious (stress) |
| Jannoun 1982 | No eligible comparison (follow‐up times differ) |
| Jarmon 1972 | Participants not clinically anxious (public speaking) |
| Jeffcoat 2012 | Participants not clinically anxious |
| Johansson 2012 | Not BT/CBT (psychodynamic) |
| Jones 2002b | Trial discontinued |
| Kahn 1968 | Participants not clinically anxious. "students who were suffering from 'subclinical phobias'" |
| Kassinove 1980 | Participants not clinically anxious (neurotic) |
| Kenwright 2005 | No eligible comparison (contact varied) |
| Khanna 2010 | Participants <18 years |
| Kiely 1984 | Participants not clinically anxious (stress) |
| Kiely 1986 | Participants not clinically anxious (stress) |
| Kilfedder 2010 | Participants not clinically anxious (stress) |
| Kirsch 1979 | Participants not clinically anxious (public speaking) |
| Klein 2009 | No eligible comparison (contact varied) |
| Kohutek 1983 | Participants not clinically anxious (stress) |
| Kupshik 1999 | No eligible comparison (contact varied) |
| Linder 1971 | Participants not clinically anxious (specific fear, mice). "white, female, college freshmen and sophomores drawn from classes...partially fulfilled a course requirement for all Ss...randomly chosen from a large population of female students who did not touch a caged mouse..." |
| Lucock 2008 | Not a RCT (alternating assignment) |
| Lucock 2011 | No eligible comparison (contact varied) |
| Lynch 1997 | Participants not clinically anxious (stress) |
| Mann 1972 | Participants not clinically anxious (test anxiety) |
| Marchand 2007 | No eligible comparison (contact varied) |
| Marshall 1976 | Participants not clinically anxious (public speaking) |
| Mataix‐Cols 2006 | Not a RCT |
| Matthews 2010 | Not a RCT |
| McGlynn 1976 | Participants not clinically anxious (specific fear, snakes). "female college undergraduates who were selected from introductory psychology classes and whose participation partially fulfilled a course requirement. They were selected in two steps. First, a Preliminary Screening Questionnaire was administered during class to all students. Then females who reported fear of nonpoisonous snakes were invited to perform a Behav‐ ioral Avoidance Test.The 40 Ss were selected randomly from a population of female students who did not touch the snake..." |
| Moritz 2011 | Participants not clinically anxious (trichotillomania). Currently classified as an impulse control disorder. |
| Muroff 2012 | Participants not clinically anxious (hoarding). Hoarding was not included in DSM‐IV and the study excluded "hoarding symptoms resulting from OCD symptoms". |
| Newman 1997 | No eligible comparison (contact varied) |
| Ormrod 2010 | Not a RCT |
| Pier 2008 | No eligible comparison (contact varied) |
| Pittaway 2009 | Not a RCT (alternating assignment) |
| Pless 2010 | Participants not clinically anxious (test anxiety) |
| Pleva 2007 | Participants not clinically anxious (perfectionism) |
| Powell 2012 | Participants not clinically anxious (mental health promotion) |
| Rahe 2002 | Participants not clinically anxious (stress) |
| Register 1991 | Participants not clinically anxious (test anxiety) |
| Rishel 1993 | Participants not clinically anxious (dental anxiety) |
| Ruwaard 2007 | Not stand‐alone (email therapy) |
| Saul 2007 | Not stand‐alone (internet chat) |
| Schelver 1983 | Participants not clinically anxious (top 15% of undergraduates) |
| Schneider 1995 | Participants not clinically anxious (stress) |
| Serrano 2009 | Participants not clinically anxious (preventive or subthreshold) |
| Smith 1987 | Participants not clinically anxious (stress) |
| Sportel 2013 | Participants <18 years |
| Tillfors 2008 | No eligible comparison (contact varied) |
| Titov 2009b | No eligible comparison (contact varied) |
| Titov 2009c | No eligible comparison (contact varied) |
| van Straten 2008 | Participants not clinically anxious (no inclusion criteria) |
| Vestre 1989 | Participants not clinically anxious (undergraduates, course credit) |
| Weissberg 1977 | Participants not clinically anxious (public speaking) |
| Wolitzky‐Taylor 2010 | Not stand‐alone (therapist led) |
| Wright 1997 | Relapse prevention. |
| Zou 2012 | Not a RCT |
Characteristics of studies awaiting assessment [ordered by study ID]
ACTRN12610001058066.
| Methods | "Study type: interventional Allocation: randomized Endpoint: efficacy Assignment: parallel Masking: blinded Primary purpose: educational/counselling/training" |
| Participants | "Key inclusion criteria
Age: 18‐64 years Gender: both males and females Key exclusion criteria
|
| Interventions | Group 1: Wait‐list control (who will begin the programme 9 weeks after the other groups). This group will receive the same intervention as Group 3 Group 2: Self‐guided Internet‐based education programme for anxiety and depression Group 3: Self‐guided Internet‐based education programme for anxiety and depression + Automatic e‐mails about new materials, upcoming lessons and reminders to complete lessons |
| Outcomes | Primary outcomes
Secondary outcomes
|
| Notes |
ACTRN12611000116921.
| Methods | "Study type: interventional Allocation: randomized Endpoint(s): not listed Assignment: parallel Masking: open (masking not used) Primary purpose: educational/counselling/training" |
| Participants | "Key inclusion criteria: an Australian resident
Key exclusion criteria
Primary hoarding concerns Suitable trial of CBT for OCD in the past (Exposure and Response Prevention (ERP) performed in a graded fashion of at least once a week with in‐session exposure)" |
| Interventions | "Participants in the treatment groups will complete 5 lessons in 8 weeks of a guided program for OCD The Internet group will complete these lessons online, the bibliotherapy group will complete these lessons from a hard copy self‐help workbook Both groups receive the same information The lessons for both groups take approximately 30 minutes to read through, with homework exercises [taking] a further hour per day The lessons are based on current best practice cognitive and behavioural techniques and include exposure and response prevention and cognitive techniques The participant is phoned twice weekly by a clinical psychologist (these days are determined by the participant) and may also be contacted at other times by the participant by e‐mail or phone. A printable information summary will also be provided, and some homework assignments will be set Comparator: The wait‐list control group receive[s] their choice of the two methods of administration (Internet or bibliotherapy) with weekly contact from a clinical psychologist once the other groups have completed the program (week 9)" |
| Outcomes | Primary outcomes
Secondary outcomes
|
| Notes | Trial acronym: The OCD Program: RCT 1 |
ACTRN12611000625976.
| Methods | "Study type: interventional Allocation: randomized Endpoint: efficacy Assignment: parallel Masking: blinded Primary purpose: educational/counselling/training" |
| Participants | "Key inclusion criteria: meet DSM‐IV criteria for social phobia and/or panic disorder (with or without agoraphobia) and/or generalised anxiety disorder－Internet access + printer access Australian citizen－males and females Minimum age: 18 years Maximum age: no limit Key exclusion criteria
|
| Interventions | Group 1: immediate Internet education group (6 lessons; one lesson will be completed every 7 to 10 days) Group 2 (control): delayed Internet education group (no contact during the 10 weeks, then will be reassessed and then provided with Internet‐based education for anxiety disorders) "The educational materials are based on the Shyness, Panic and Worry Program, which applies cognitive behavioural techniques Participants in both groups will receive weekly reminder telephone calls, and have access to a moderated online forum (the duration of phone calls and forum participation is expected to be 2‐7 mins) Duration of the program is 9 weeks Participants will be contacted 3 months post program and asked to complete follow‐up questionnaires. Study questionnaires will be administered at application, pre‐education, post‐education, and at 3‐months post‐education" |
| Outcomes | Primary outcomes
Secondary outcomes
|
| Notes |
ACTRN12611000626965.
| Methods | "Study type: interventional Allocation: randomized Endpoint: efficacy Assignment: parallel Masking: open (masking not used) Primary purpose: treatment" |
| Participants | "Key inclusion criteria: accepted for treatment for social phobia at the St Vincent's Anxiety Disorders Clinic Minimum age: 18 years Maximum age: 99 years Key exclusion criteria: Intake clinicians at the clinic do not offer treatment to people with comorbid psychosis, substance use disorder or severe personality disorder" |
| Interventions | Group 1: cognitive behaviour therapy delivered by the Internet Group 2 (control): cognitive behaviour therapy delivered in the clinic on a face‐to‐face basis Both groups receive six sessions/lessons of less than 50 minutes on a 7‐10 day schedule following the content outlined in Andrews et al, Treatment of anxiety disorders, Cambridge University Press, 2003 (psychoeducation, de‐arousal strategies, cognitive therapy, graded exposure) |
| Outcomes | "Primary outcome: reduction in social phobia as demonstrated from scores on Social Interaction Anxiety Scale (SIAS) and Social Phobia Scale (SPS) Secondary outcome: reduction in comorbid depression and anxiety as demonstrated from changes in the PHQ‐9 and GAD‐7 Timepoints: at 12 weeks after beginning treatment" |
| Notes |
Andersson 2011.
| Methods | "Study type: interventional Study design: allocation: randomized Endpoint classification: efficacy study Intervention model: parallel assignment Masking: open label Primary purpose: treatment" |
| Participants | "Inclusion criteria
Exclusion criteria
|
| Interventions | Active treatment: Internet‐delivered cognitive behavior therapy, 8 weeks' treatment, guided self‐help Active treatment: Internet‐delivered psychodynamic therapy active treatment: Internet‐delivered psychodynamic therapy, 8 weeks' treatment, guided self‐help Wait‐list condition, received treatment 3 months after initial treatment period |
| Outcomes | Penn State Worry Questionnaire (PSWQ) Montgomery Åsberg Depression Rating Scale‐Self Rated (MADRS‐S) Quality of Life Inventory (QOLI) Beck Depression Inventory (BDI) Beck Anxiety Inventory (BAI) Trimbos and iMTA Questionnaire on Costs Associated with Psychiatric illness (TIC‐P) State Trait Anxiety Inventory (STAI) Generalized Anxiety Disorder Questionnaire IV (GAD‐Q IV) |
| Notes |
Bohus 2010.
| Methods | Study type: interventional Study design: allocation: randomised Endpoint classification: efficacy study Intervention model: parallel assignment Masking: single blind (outcomes assessor) Primary purpose: treatment |
| Participants | “Inclusion criteria
Exclusion criteria
|
| Interventions | "Active comparator: SCP stepped‐care program with self‐help module with minimal therapist contact as first step, followed by therapist‐guided intervention depending on status of remission" "Active comparator: ST standard therapy (therapist‐guided intervention only)" |
| Outcomes | Social anxiety (Self‐ratings: SIAS, SPS, SPAI. Clinician rating: LSAS) Global severity of psychopathology (Brief Symptom Inventory; BSI) Depressive symptomatology (German Version of the CES‐D) Cognitive, affective, behavioral and autonomic indicators of anxiety in social situations |
| Notes |
Christensen 2010.
| Methods | Study type: interventional Study design: multicentre randomised controlled trial Primary purpose: treatment Duration: 10 week treatment phase with 12 month follow‐up (measures administered at screening, baseline, post‐test and 6 and 12 months after post‐test) |
| Participants | Inclusion criteria:
|
| Interventions | Treatment trial Group 1: E‐couch Website (which covers psychoeducation; cognitive behaviour therapy; relaxation; and physical activity) Group 2: sertraline (25 mg‐50 mg/d) Group 3: attention control All conditions will also involve four face‐to‐face clinician monitoring sessions |
| Outcomes | Primary outcome measure: Generalised Anxiety Disorder Questionnaire (GAD‐7) |
| Notes | There are two separate studies within one trial registration [ISRCTN76298775]. The treatment trial will use participants for whom a diagnosis of GAD has been confirmed, whereas the prevention trial will involve participants who score at a subclinical yet elevated level for GAD |
Donker 2009.
| Methods | "Randomised controlled trial" |
| Participants | "500 subjects (18 year and older) from the general population with mild to moderate depression and/or anxiety" |
| Interventions | "(1) Web‐based problem solving through the Internet (self‐examination therapy) without a coach (2) the same as 1, but with the possibility to ask help from a coach on the initiative of the respondent (on demand, by e‐mail) (3) the same as 1, but with weekly scheduled contacts initiated by a coach (once per week, by e‐mail) (4) weekly scheduled contacts initiated by a coach, but no Web‐based intervention (5) information only (through the Internet)" |
| Outcomes | "Primary outcome measures are symptoms of depression and anxiety. Secondary outcome measures are dropout from the intervention, quality of life and economic costs. Other secondary outcome measures that may predict outcome are also studied (e.g. client satisfaction and problem‐solving skills)" |
| Notes |
DRKS00004612.
| Methods | "Study type: interventional
Allocation: randomized controlled trial Masking: open (masking not used) Control: no treatment Assignment: parallel Study design purpose: treatment" |
| Participants | "Inclusion criteria: current obsessive‐compulsive disorder according to DSM‐IV criteria (self‐rating scale Y‐BOCS‐SR and OCI‐R, as well as phone interview); informed consent to participate in the study; fluent in spoken and written German; access to Internet; agreement from their outpatient psychiatrist for crisis intervention Target sample: 40 Age: 18‐65 years" |
| Interventions | "Intervention 1: experimental intervention: Internet‐based cognitive‐behavioral psychotherapy for adults with OCD Intervention 2: control intervention: waiting‐list control condition" |
| Outcomes | "Yale‐Brown Obsessive Compulsive Scale Obsessive Compulsive Intentory‐Revised" |
| Notes |
Greist 2008.
| Methods | Randomised controlled trial |
| Participants | "Men and women aged 18 years, with OCD of at least 1 year's duration, meeting DSM‐IV diagnostic criteria, and having a baseline Yale‐Brown Obsessive‐Compulsive Scale (Y‐BOCS) score of 18" |
| Interventions | "The Web‐based CBT (CT STEPS) includes an introductory session explaining the treatment, with videotapes of OCD patients who used an earlier version, along with 9 subsequent treatment modules. The CBT will include weekly e‐mail feedback from a psychologist in response to questions asked about the CBT by the subjects assigned to this treatment arm" |
| Outcomes | Y‐BOCS Work and Social Adjustment Scale Work Productivity and Activity Impairment Questionnaire Specific Health Problem Scale Cost |
| Notes | NCT00743834 |
Griffiths 2010a.
| Methods | Randomised controlled trial |
| Participants | Inclusion criteria
Exclusion criteria
|
| Interventions | Intervention group one: D‐couch Intervention group two: Talking Point Control group: HealthWatch "Participants receive one of the above conditions or a combination of D‐couch and Talking Point" |
| Outcomes | Centre for Epidemiology Studies‐Depression (CES‐D)
|
| Notes |
ISRCTN36376369.
| Methods | "Randomised trial" |
| Participants | "Inclusion criteria:
"Target number of participants: 130" |
| Interventions | "130 patients (across different treatment centres) will be randomly allocated to one of two treatment conditions:
|
| Outcomes | "Primary outcome measures:
|
| Notes |
Kerkhof 2005.
| Methods | "Randomised, active controlled, crossover trial" |
| Participants | Inclusion criteria
Exclusion criteria
|
| Interventions | "A self‐help brochure, with or without telephonic support. These exercises take one month's time. In the support condition, participants are contacted by telephone on a weekly basis for (minimal) support" |
| Outcomes | "Decrease in worrying intensity" "Decrease in anxiety, depression, sleeplessness" |
| Notes |
Kool 2007.
| Methods | "Randomised, controlled, parallel‐group multicentre trial" |
| Participants | "They are recruited through screening (all patients who visited their General Practitioner (GP)). They have to meet the following criteria:
Exclusion criteria
|
| Interventions | "A stepped care program is characterised by different steps of treatment that are arranged in order of increasing intensity. After each step, the patient will be monitored, to determine if symptoms have been sufficiently reduced. The program consists of evidence‐based interventions
The control condition is care as usual" |
| Outcomes | Quick Inventory of Depressive Symptomatology (QIDS) Hospital Anxiety and Depression Scale (HADS‐A) for Anxiety DSM diagnosis (Composite International Diagnostic Interview (CIDI)) Quality of life (Short Form health survey [SF36] and EuroQol questionnaire) The use of health care services (Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness (TIC‐P)) The use of medication (TIC‐P) Productivity losses (TIC‐P) Satisfaction with delivered care/continuity of care (Quote) |
| Notes |
Lacasse 2010.
| Methods | "Randomised controlled trial" |
| Participants | "Participants self‐report as having depression or anxiety Adults (age 18 or above)" |
| Interventions | "Psychoeducational course on mindfulness and lifestyle interventions for depression and anxiety" |
| Outcomes | Beck Depression Inventory (BDI) Beck Anxiety Inventory (BAI) Medication use Currently seeing therapist |
| Notes |
Martinez 2008.
| Methods | "Randomised controlled trial" |
| Participants | "Inclusion criteria
Exclusion criteria
|
| Interventions | "This is a pilot randomised controlled trial comparing an online life skills package, Living Life To The Full (LLTTF), which is based on the cognitive behaviour therapy model, delivered with brief e‐mail support (at least one e‐mail per week), compared with matched e‐mail support in the other arm of the study" |
| Outcomes | Beck Anxiety Inventory (BAI) Beck Depression Inventory (BDI‐II) Work And Social Adjustment Scale (WASAS) Single‐item satisfaction scale Four items assessing mental health literacy |
| Notes |
Moore 1998.
| Methods | Title only |
| Participants | |
| Interventions | |
| Outcomes | |
| Notes |
Muntingh 2009.
| Methods | "Two armed, cluster randomised controlled trial" |
| Participants | "Primary care patients with a DSM‐IV diagnosis of PD and/or GAD will be included" |
| Interventions | "In the CSC group, a general practitioner, care manager and psychiatrist work together in a collaborative care framework. Stepped care is provided in three steps: (1) guided self‐help, (2) cognitive behavioral therapy and (3) antidepressant medication" |
| Outcomes | Beck Anxiety Inventory (BAI) "Data on anxiety symptoms, mental and physical health, quality of life, health resource use and productivity" |
| Notes |
NTR1260.
| Methods | Randomised, single‐blind, parallel‐group intervention trial |
| Participants | "Inclusion criteria
Exclusion criteria
Target number of participants: 60 |
| Interventions | "Internet‐based guided self‐help for patients suffering from a phobia (program based on cognitive behavioural therapy with a focus on exposure, with minimal guidance) The intervention will take about 12 weeks consisting of 6 sessions and home work in between sessions" "In this pilot trial we want to treat patients who are waiting for cognitive‐behavioural therapy in a specialised mental health care institute with the guided self‐help. We expect the patients to evaluate the treatment as feasible and satisfying" Control: unclear |
| Outcomes | Feasability with and satisfaction about use of the treatment Decrease in anxiety level |
| Notes |
NTR2573.
| Methods | Randomised, open‐label, parallel‐group, active‐controlled, intervention trial |
| Participants | "Inclusion criteria
Exclsuion criteria
Target number of participants: 128 |
| Interventions | "Experimental group: self‐help book (which entails 6 different techniques, based on elements from cognitive behavioural therapy) Control group: waiting‐list (no self‐help book during 3 month wait‐list period, but participants are free to seek help through the common channels in this time) Duration of the intervention may vary from 6 to 10 weeks, depending on the pace of the individual respondent Guidance by specially trained students and research assistants is mainly focused on motivating the respondent to work through the entire book, whilst providing feedback and information in case of any misunderstanding of the assignments described in the book" |
| Outcomes | Rosenberg Self‐esteem Scale |
| Notes |
Schmidt 2008.
| Methods | "Study type: interventional Study design: allocation: randomized Endpoint classification: efficacy study Intervention model: parallel assignment Masking: open label Primary purpose: treatment" |
| Participants | Inclusion criteria
Exclusion criteria
|
| Interventions | "Participants in this study will be randomly assigned to receive computer based treatment, book based treatment, or no treatment for 10 weeks" |
| Outcomes | "After these 10 weeks, symptoms of anxiety and depression will be measured with patient interviews, scales, and questionnaires" |
| Notes |
Spooner 2011.
| Methods | Randomised controlled trial |
| Participants | Not described |
| Interventions |
|
| Outcomes | Not described |
| Notes |
Titov 2011a.
| Methods | Randomised controlled trial |
| Participants | "All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM‐IV) criteria for depression and/or social phobia and/or panic disorder (with or without agoraphobia) and/or generalised anxiety disorder (GAD)" |
| Interventions | "Participants will be randomly assigned to one of two groups: (1) an immediate treatment group, or (2) a delayed treatment group, also known as a wait‐list control group" |
| Outcomes | Generalised Anxiety Disorder‐7 Item Scale (GAD‐7) Social Phobia Scale (SPS) Social Interaction Anxiety Scale (SIAS) NEO‐Five Factor Inventory (NEO‐FFI) Neuroticism Scale Sheehan Disability Scale (SDS) Kessler 10‐Item Scale (K‐10) Panic Disorder Severity Rating Scale－Self‐Report Version (PDSS‐SR) Penn State Worry Questionnaire (PSWQ) Patient Health Questionnaire‐9 (PHQ‐9) |
| Notes |
van Ballegooijen 2011.
| Methods | Randomised controlled trial |
| Participants | "Participants with mild or sub‐clinical PD" |
| Interventions | Don’t Panic Online (DPO) Wait list |
| Outcomes | "Severity of panic and anxiety symptoms are the primary outcome measures. Secondary outcomes include depressive symptoms, quality of life, loss of production and health care consumption" |
| Notes |
Characteristics of ongoing studies [ordered by study ID]
ACTRN12610001081000.
| Trial name or title | Cognitive Behavioural, Guided Self‐Help for Clinical Perfectionism Versus Guided Self‐Help for Anxiety and Depression |
| Methods | "Study type: interventional Allocation: randomized Primary purpose: treatment" |
| Participants | "Key inclusion criteria
Key exclusion criteria
Target sample: 75 |
| Interventions | Duration trial: 8 weeks Group 1: guided self‐help book for clinical perfectionism Group 2: guided self‐help book for anxiety and depression Group 3: wait‐list‐control (randomly allocated to Group 1 or 2 after 8 weeks) |
| Outcomes | Primary outcomes
Secondary outcomes
|
| Starting date | 01/2011 |
| Contact information | s.egan@curtin.edu.au |
| Notes |
ACTRN12611000321943.
| Trial name or title | Internet‐Based Cognitive‐Behavioural Treatment for Obsessive‐Compulsive Disorder |
| Methods | "Study type: interventional Allocation: randomized Masking: blinded Assignment: parallel Primary purpose: treatment Endpoint: efficacy" |
| Participants | "Key inclusion criteria
Key exclusion criteria
Target sample: 212 |
| Interventions | Duration: 12 weeks; 1 module (of 1 hour duration) completed each week Group 1: Therapist‐assisted, Internet‐based treatment (adapted from a maualised face‐to‐face CBT programme: OCD‐STOP) Group 2: Progressive relaxation training for anxiety (PRT) Upon completing the PRT and post‐treatment measures, individuals will complete the therapist‐assisted OCD STOP free of charge |
| Outcomes | Primary outcomes
Secondary outcomes
|
| Starting date | 04/2011 |
| Contact information | mkyrios@swin.edu.au |
| Notes |
ACTRN12611001052921.
| Trial name or title | Online Self‐Help Meta‐Cognitive Therapy for Obsessive‐Compulsive Disorder |
| Methods | "Study type: interventional Allocation: randomized Masking: open (masking not used) Assignment: parallel Primary purpose: treatment Endpoint: efficacy" |
| Participants | "Key inclusion criteria
Key exclusion criteria
Target sample size: 40 |
| Interventions | Group 1: online meta‐cognitive therapy for OCD (10 modules) Group 2 (active control): online (audio) progressive muscle relaxation training (weekly exercises of 15‐30 minutes duration) Duration of trial: 6 weeks After implementation and evaluation of the programme is complete, participants in Group 2 will be provided with access to the online MCT programme if they wish |
| Outcomes | "Primary outcomes
Secondary outcomes
|
| Starting date | 07/2012 |
| Contact information | C.Rees@curtin.edu.au |
| Notes | Trial Website: http://ocd‐doctor‐online.squarespace.com/ |
ACTRN12611001055998.
| Trial name or title | The Wellbeing6 Program for Generalized Anxiety Disorder (GAD) and/or Depression |
| Methods | "Study type: interventional Allocation: randomized Masking: open (masking not used) Assignment: parallel Primary purpose: treatment Endpoint: efficacy" |
| Participants | "Key inclusion criteria
Key exclusion criteria
Target sample size: 100" |
| Interventions | Group 1: clinician‐assisted Internet‐based cognitive behavioural therapy for generalised anxiety disorder (GAD) and/or depression Group 2: Wait‐list control group Duration of trial: 10 weeks 6 online lessons (of 15 minutes' duration) to be completed (consecutively) every 7‐14 days After 10 weeks, participants in the wait‐list control group will receive the same treatment as Group 1 |
| Outcomes | "Primary outcomes
Secondary outcomes
|
| Starting date | 10/2011 |
| Contact information | gavina@unsw.edu.au |
| Notes | Trial acronym: Wellbeing6. Trial Website: www.virtualclinic.org.au |
ACTRN12612000430831.
| Trial name or title | Factorial, Internet‐Delivered Self‐Guided versus Therapist‐Guided Treatment (disorder‐specific or trans‐diagnostic) for Social Phobia |
| Methods | "Study type: interventional Allocation: randomized Masking: blinded Assignment: factorial Primary purpose: treatment Endpoint: efficacy" |
| Participants | "Key inclusion criteria
Key exclusion criteria
Target population: 208" |
| Interventions | Factorial, 2 (self‐guided vs guided) × 2 (trans‐diagnostic vs disorder‐specific) treatment for social phobia Duration of trial: 8 weeks |
| Outcomes | "Primary outcomes
Secondary outcomes
|
| Starting date | 04/2012 |
| Contact information | nick.titov@mq.edu.au |
| Notes | Trial acronym: WELLRCT5 |
ACTRN12612000431820.
| Trial name or title | Factorial, Internet‐Delivered Self‐Guided versus Therapist‐Guided Treatment (disorder‐specific or trans‐diagnostic) for Panic Disorder |
| Methods | "Study type: interventional Allocation: randomized Masking: blinded Assignment: factorial Primary purpose: treatment Endpoint: efficacy" |
| Participants | "Key inclusion criteria
Key exclusion
Target sample size: 208" |
| Interventions | Factorial, 2 (self‐guided vs guided) × 2 (trans‐diagnostic vs disorder‐specific) treatment for panic disorder Duration of trial: 8 weeks |
| Outcomes | "Primary outcomes
Secondary outcomes
|
| Starting date | 10/2011 |
| Contact information | nick.titov@mq.edu.au |
| Notes | Trial acronym: WELLRCT6 |
ACTRN12612000433808.
| Trial name or title | Factorial, Internet‐Delivered Self‐Guided versus Therapist‐Guided Treatment (disorder‐specific or trans‐diagnostic) for Generalised Anxiety Disorder |
| Methods | "Study type: interventional Allocation: randomized Masking: blinded Assignment: factorial Primary purpose: treatment Endpoint: efficacy" |
| Participants | "Key inclusion criteria
Key exclusion criteria
Target sample size: 208" |
| Interventions | Factorial, 2 (self‐guided vs guided) × 2 (trans‐diagnostic vs disorder‐specific) treatment for generalised anxiety disorder Duration of trial: 8 weeks |
| Outcomes | "Primary outcomes
Secondary outcomes
|
| Starting date | 04/2012 |
| Contact information | nick.titov@mq.edu.au |
| Notes | Trial acronym: WELLRCT4 |
ACTRN12612001073897.
| Trial name or title | Internet‐Based Cognitive Behavioural Therapy for Obsessive Compulsive Disorder (OCD) |
| Methods | "Study type: interventional Allocation: randomized Masking: open (masking not used) Assignment: parallel Primary purpose: treatment Endpoint: efficacy" |
| Participants | "Key inclusion criteria
Key exclusion criteria
Target sample size: 50" |
| Interventions | Group 1: clinician‐assisted Internet based cognitive behavioural therapy for obsessive compulsive disorder (OCD) Group 2: Wait‐list control group Duration of trial: 10 weeks 6 online lessons (of 15 minutes' duration) to be completed (consecutively) every 7‐14 days After 10 weeks, participants in the wait‐list control group will receive the same treatment as Group 1 |
| Outcomes | "Primary outcomes
Secondary outcomes
|
| Starting date | 10/2012 |
| Contact information | gavina@unsw.edu.au |
| Notes | Trial acronym: The OCD Program. Trial Website: www.virtualclinic.org.au |
ACTRN12612001306808.
| Trial name or title | Internet‐Based Cognitive Behavioural Therapy for Obsessive Compulsive Disorder (OCD) |
| Methods | "Study type: interventional Allocation: randomized Masking: open (masking not used) Assignment: parallel Primary purpose: treatment Endpoint: efficacy" |
| Participants | "Key inclusion criteria
Key exclusion criteria
Target sample size: 50" |
| Interventions | Group 1: Internet‐based CBT (iCBT) Group 2: clinician‐guided, face‐to‐face CBT (treatment manual) Duration of trial: 12 weeks |
| Outcomes | "Primary outcomes
Secondary outcomes
|
| Starting date | 01/2013 |
| Contact information | gavina@unsw.edu.au |
| Notes | Trial Website: www.virtualclinic.org.au |
Carlbring 2012a.
| Trial name or title | Internet‐Based Treatment of Generalized Anxiety Disorder |
| Methods | Randomised controlled trial |
| Participants | Satisfy DSM‐IV criteria for generalised anxiety disorder |
| Interventions | iCBT |
| Outcomes | Penn State Worry Questionnaire (PSWQ) Beck Anxiety Inventory (BAI) Quality of Life Inventory (QOLI) Montgomery‐Åsberg Depression Rating Scale (MADRS) Patient Health Questionnaire (PHQ‐9) Generalized Anxiety Disorder‐7 (GAD‐7) |
| Starting date | 31/03/2012 |
| Contact information | per.carlbring@psy.umu.se |
| Notes | NCT01570374 |
Carlbring 2012b.
| Trial name or title | An Internet‐Administered, Mindfulness Training Program for the Treatment of Anxiety |
| Methods | Randomised controlled trial |
| Participants | Satisfy DSM‐IV criteria for an anxiety disorder |
| Interventions | "A 10 week, Internet‐administered mindfulness training program, featuring no therapist‐support. 10 minutes of training, twice per day" |
| Outcomes | Beck Anxiety Inventory (BAI) Beck Depression Inventory (BDI) Quality of Life Inventory (QOLI) Insomnia Severity Index (ISI) |
| Starting date | 03/2012 |
| Contact information | per.carlbring@psy.umu.se |
| Notes | NCT01577290 |
Clark 2012.
| Trial name or title | Internet‐Based Cognitive Therapy for Social Anxiety Disorder |
| Methods | Randomised controlled trial |
| Participants | Adults with social anxiety |
| Interventions | Internet‐based self‐help |
| Outcomes | ADIS Social Phobia Weekly Summary Scale Liebowitz Social Anxiety Scale Fear of Negative Evaluation Scale Social Phobia Scale Social Interaction and Anxiety Scale PHQ‐9 Sheehan Disability Scale Social Cognitions Questionnaite Social Attitudes Questionnaire Treatment Credibility Scale Working Alliance Inventory |
| Starting date | 01/01/2013 |
| Contact information | david.clark@psy.ox.ac.uk |
| Notes | ISRCTN95458747 |
Havik 2012.
| Trial name or title | Treatment of Social Phobia and Panic Disorder in Adults (TSPPA) |
| Methods | Randomised |
| Participants | Clinical diagnosis of panic disorder or social phobia |
| Interventions | individual cognitive‐behavioural therapy Stepped‐care: short psycho‐education, a 10 week Internet‐based self‐help programme, 12 weeks' individual cognitive‐behavioural therapy |
| Outcomes | Clinical Severity Ratings Panic Attack Scale Body Sensations Questionnaire Agoraphobic Cognitions Questionnaire Mobility Inventory for Agoraphobia Social Phobia Scale Social Interaction Anxiety Scale |
| Starting date | 16/01/2008 |
| Contact information | Odd E Havik, University of Bergen |
| Notes | NCT00619138 |
Hedman 2012.
| Trial name or title | Cognitive Behavioral Therapy, Guided Self‐Help Versus Individual Therapy |
| Methods | Randomised controlled trial |
| Participants | "Have an anxiety disorder diagnosis (obsessive compulsive disorder, social phobia, panic disorder, generalized anxiety disorder), or/and major depression, or/and maladaptive stress reaction, or/and primary insomnia. Clinician severity rating scale 2‐6" |
| Interventions | Group 1: "After the initial guided self‐help, patients in this arm continue the same self‐help program with 1 additional guiding session" Group 2: "After the initial face of self‐help CBT, patients in this arm receive individual CBT. The cognitive behavior therapy used in the study will be based on the protocols with best empirical support. The therapy is delivered by the same psychologist as in the first face, and the second face builds on the learnings from the first face" |
| Outcomes | Clinician Severity Rating (CSR) Montgomery‐Åsberg Depression Rating Scale－Self‐report (MADRS‐S) Work Ability Index (WAI) Insomnia Severity Index (ISI) Health Anxiety Inventory (HAI) Perceived Stress Scale (PSS) Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC‐P) Quality of Life Inventory (QOLI) EuroQol‐5 Dimension (EQ5D) Sheehan Disability Scales (SDS) Self‐Rated Health 5 (SRH‐5) Obsessive Compulsive Inventory－Revised (OCI‐R) Liebowitz Social Anxiety Scale Self‐Report (LSAS‐SR) Panic Disorder Severity Scale Self‐Rated (PDSS‐SR) Penn State Worry Questionnaire (PSWQ) |
| Starting date | 08/2012 |
| Contact information | kire.hedman@ki.se; sigrid.salomonsson@sll.se |
| Notes | NCT01667822 |
Hedman 2013.
| Trial name or title | Internet Treatment for Health Anxiety (HA‐X) |
| Methods | Randomised controlled trial |
| Participants | Adults with health anxiety |
| Interventions | Group 1: CBT, exposure and response prevention Group 2: BSM, stress management and applied relaxation |
| Outcomes | Health Anxiety Inventory (HAI) Illness Attitude Scale (IAS) Whiteley Index (WI) Montgomery‐Åsberg Depression Rating Scale－Self‐report (MADRS‐S) Beck Anxiety Inventory (BAI) Anxiety Sensitivity Index (ASI) Insomnia Severity Index (ISI) Sheehan Disability Scale (SDS) Trimbos and Institute of Medical Technology Assessment Cost Questionnaire (TIC‐P) EuroQol‐5D (EQ‐5D) Obsessive Compulsive Inventory Revised (OCI‐R) Yale‐Brown Obsessive Compulsive Scale (YBOCS) AUDIT (alcohol use) |
| Starting date | 09/2012 |
| Contact information | kire.hedman@ki.se |
| Notes | NCT01673035 |
ISRCTN73535163.
| Trial name or title | Obsessive Compulsive Treatment Efficacy Trial |
| Methods | Randomised controlled trial |
| Participants | "Inclusion criteria:
Target number of participants: 432 |
| Interventions |
|
| Outcomes | Yale‐Brown Obsessive Compulsive Scale (YBOCS) checklist |
| Starting date | 09/2011 |
| Contact information | Karina.Lovell@manchester.ac.uk |
| Notes | Trial acronym: OCTET |
Kok 2012.
| Trial name or title | Internet‐Based Treatment of Phobias in Specialized Mental Health Care: A Randomised Trial－FocD (Fobieen onder controle Doelmatigheid) |
| Methods | Randomised controlled trial |
| Participants | Adults with a social‐, agora‐, or specific phobia in a mental health care institute are eligible |
| Interventions | "Fobieën onder controle" by Manja de Neef and Pim Cuijpers |
| Outcomes | Fear Questionnaire (FQ) Beck Anxiety Inventory (BAI) Center for Epidemiologic Studies‐Depression (Ces‐D) Client Satisfaction Questionnaire (CSQ) Short Form‐Health and Labour Questionnaire (SF‐HLQ) Quality of Life in Economic Evaluations (EQ‐5d) Trimbos/Imta Tic‐P Questionnaire for Costs Associated With Psychiatric Illness (Tic‐P) Cut‐Annoyed‐Guilty‐Eye opener (CAGE‐alcohol questionnaire) |
| Starting date | 1/10/2010 |
| Contact information | ga.schreuders@psy.vu.nl |
| Notes | NTR2233 |
Nordgren 2012.
| Trial name or title | Tailored Internet‐Administered Treatment of Anxiety Disorders for Primary Care Patients |
| Methods | Randomised controlled trial |
| Participants | “Inclusion criteria
Exclusion criteria
|
| Interventions | "Behavioral: Tailored Internet‐administrated CBT Treatment Behavioral: Wait‐list" |
| Outcomes | Clinical Outcome in Routine Evaluation‐Outcome Measure (CORE‐OM) Montgomery‐Åsberg Depression Rating Scale‐Self‐rated (MADRS‐S) Quality of Life Inventory (QOLI) |
| Starting date | |
| Contact information | |
| Notes |
NTR1985.
| Trial name or title | Self‐Help Acceptance and Commitment Therapy for Psychological Distress |
| Methods | Study type: interventional Allocation: randomised Masking: open label Assignment: parallel |
| Participants | "Inclusion criteria: people of 18 years and older with mild to moderate psychological distress (anxiety, depression), fatigue and/or with low mental health" |
| Interventions |
|
| Outcomes | "Primary outcome: decreased psychological distress (depression measured with the CES‐D and anxiety measured with the HADS‐A) Secondary outcome: increased mental health, measured with the MHC‐SF" |
| Starting date | 03/2009 |
| Contact information | e.t.bohlmeijer@gw.utwente.nl |
| Notes | Trial Website:www.cursusmindfulness.nl |
Proudfoot 2010.
| Trial name or title | Evaluation of Electronic Program to Help People Self‐Monitor and Self‐Manage of Mild to Moderate Mental Health Problems |
| Methods | Randomised controlled trial |
| Participants | Key inclusion criteria
Key exclusion criteria
|
| Interventions | Participants receiving the intervention will use an electronic self‐monitoring and self‐management programme for 6 weeks, accessed via their mobile phone and computer. The programme consists of real‐time monitoring of symptoms with SMS prompts, therapeutic modules, fact sheets, tips, motivational messages and a journal There are two control groups: (1) an online attention control providing minimal information about depression, anxiety and stress, together with weekly motivational messages for 6 weeks; (2) a wait‐list control, who will receive the full electronic self‐monitoring and self‐management programme immediately after the intervention group concludes their treatment (6 weeks after the start of the programme) |
| Outcomes | Mean Depression Anxiety Stress Scales (DASS) score Subjective Units of Distress Scales (SUDS) Work & Social Adjustment Scale Utilisation of Health Services: This will be assessed using a questionnaire asking for details about participants' use of varying health services and medications Self‐efficacy for coping with depression, anxiety and stress: This will be assessed using our new six‐item questionnaire developed using Bandura's (2006) guidelines |
| Starting date | 17/09/2010 |
| Contact information | v.harrison@unsw.edu.au, j.proudfoot@unsw.edu.au |
| Notes |
Rollman 2012.
| Trial name or title | Online Treatments for Mood and Anxiety Disorders in Primary Care |
| Methods | Randomised |
| Participants | 18‐75 years of age Current major depression, panic and/or generalised anxiety disorder on PRIME‐MD |
| Interventions | Computerised CBT + Internet support group Computerised CBT alone Usual care |
| Outcomes | SF‐12 MCS Hamilton Rating Scale for Depression Hamilton Rating Scale for Anxiety WHO Health and Work Performance Questionnaire Health Services Utilization and Costs Attitudes to Computerized CBT Computerized CBT and Internet Support Group Usage |
| Starting date | 22/11/11 |
| Contact information | Bruce Rollman, University of Pittsburgh |
| Notes | NCT01482806 |
Tulbure 2012.
| Trial name or title | Internet Treatment for Social Phobia (iSOFIE‐Ro) |
| Methods | Randomised controlled trial |
| Participants | Adults with social anxiety |
| Interventions | "Internet‐administrated CBT for Social Phobia that contains 9 self‐help text modules and exercises (i.e. behavioral experiments)" |
| Outcomes | Leibowitz Social Anxiety Scale‐Self‐Report (LSAS‐SR) Social Phobia Inventory (SPIN) Beck Depression Inventory‐II (BDI‐II) Attitude and Belief Scale‐II (ABS‐II) Anxiety Sensitivity Index (ASI) Social Interaction and Anxiety Scale (SIAS) Social Phobia Screening Questionnaire (SPSQ) |
| Starting date | 04/12 |
| Contact information | Gerhard.Andersson@liu.se; btulbure@gmail.com , bogdan.tulbure@ubbcluj.ro |
| Notes | NCT01557894 |
Differences between protocol and review
In addition to the CCDAN Controlled Trials Register, we searched MEDLINE and PsycINFO. In both cases, we used terms to identify media‐delivered interventions for anxiety. Methods for assessing risk of bias were updated to follow current guidelines. We included measures of disability that were not specified in the protocol. We were unable to assess the use of other services, satisfaction, adverse events or cost.
The prespecified primary outcome, "Specific symptoms of anxiety", had to be refined because studies used several relevant measures. First, we analysed the average effects of all measures for each study. For studies of a single disorder, we also analysed specific measures of that disorder (e.g. LSAS) apart from general measures of anxiety (e.g. BAI). For studies including behavioural tests, which are commonly used to evaluate phobic avoidance, we analysed the level in the hierarchy achieved and subjective distress.
We added a Summary of findings table.
Contributions of authors
Both review authors contributed to designing the project and to writing the protocol. EM‐W conducted the searches and screened citations for eligibility with PM or with G.J. Melendez‐Torres. EM‐W extracted data (with Robyn Cox (RC), Jean Junior (JJ), Andreas Hein Willius (AH) or Kayleigh Kew (KK)), conducted the analyses and wrote a first draft of the results. Both review authors contributed to the interpretation and discussion.
Sources of support
Internal sources
Centre for Evidence‐Based Intervention (Department of Social Policy and Intervention), University of Oxford, UK.
Centre for Outcomes Research and Effectiveness (Research Department of Clinical, Educational & Health Psychology), University College London, UK.
External sources
No sources of support supplied
Declarations of interest
None.
New
References
References to studies included in this review
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References to studies awaiting assessment
ACTRN12610001058066 {published data only}
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ACTRN12611000116921 {published data only}
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ACTRN12611000625976 {published data only}
- ACTRN12611000625976. A randomized controlled trial of Internet based education for social phobia, panic disorder (with or without agoraphobia), and generalised anxiety disorder, comparing immediate education versus delayed education groups on severity of symptoms of anxiety. www.anzctr.org.au/ACTRN12611000625976.aspx (accessed 26 February 2013).
ACTRN12611000626965 {published data only}
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Kerkhof 2005 {published data only}
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NTR2573 {published data only}
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Schmidt 2008 {published data only}
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Titov 2011a {published data only}
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van Ballegooijen 2011 {published data only}
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References to ongoing studies
ACTRN12610001081000 {published data only}
- ACTRN12610001081000. A randomised control trial of guided self help cognitive behavioural therapy for clinical perfectionism versus a guided self help cognitive behavioural therapy for anxiety and depression. www.anzctr.org.au/ACTRN12610001081000.aspx (accessed 26 February 2013).
ACTRN12611000321943 {published data only}
- ACTRN12611000321943. Internet‐based cognitive‐behavioural therapy for obsessive‐compulsive disorder. www.anzctr.org.au/ACTRN12611000321943.aspx (accessed 26 February 2013).
ACTRN12611001052921 {published data only}
- ACTRN12611001052921. Development, evaluation and implementation of an online metacognitive intervention programme for obsessive‐compulsive disorder. www.anzctr.org.au/ACTRN12611001052921.aspx (accessed 26 February 2013).
ACTRN12611001055998 {published data only}
- ACTRN12611001055998. The Wellbeing6 Program for Anxiety and Depression: a randomised controlled trial. www.anzctr.org.au/ACTRN12611001055998.aspx (accessed 26 February 2013).
ACTRN12612000430831 {published data only}
- ACTRN12612000430831. Is internet‐delivered treatment specifically for symptoms of social phobia as effective as internet‐delivered treatment for symptoms of both anxiety and depression, and are self‐guided versions of these as effective as therapist‐guided versions?. www.anzctr.org.au/ACTRN12612000430831.aspx (accessed 26 February 2013). [Google Scholar]
ACTRN12612000431820 {published data only}
- ACTRN12612000431820. Is internet‐delivered treatment specifically for symptoms of panic disorder as effective as internet‐delivered treatment for symptoms of both anxiety and depression, and are self‐guided versions of these as effective as therapist‐guided versions?. www.anzctr.org.au/ACTRN12612000431820.aspx (accessed 26 February 2013).
ACTRN12612000433808 {published data only}
- ACTRN12612000433808. Is internet‐delivered treatment specifically for symptoms of generalised anxiety disorder as effective as internet‐delivered treatment for symptoms of both anxiety and depression, and are self‐guided versions of these as effective as therapist‐guided versions?. www.anzctr.org.au/ACTRN12612000433808.aspx (accessed 26 February 2013).
ACTRN12612001073897 {published data only}
- ACTRN12612001073897. The Obsessive Compulsive Disorder (OCD) program: a randomised controlled trial comparing clinician‐assisted Internet based treatment for OCD vs. a waitlist control condition on severity of symptoms of OCD. www.anzctr.org.au/ACTRN12612001073897.aspx (accessed 26 February 2013). [Google Scholar]
ACTRN12612001306808 {published data only}
- ACTRN12612001306808. The Obsessive Compulsive Disorder (OCD) program: a randomised controlled trial of online versus face‐to‐face cognitive behavioural therapy (CBT). www.anzctr.org.au/ACTRN12612001306808.aspx (accessed 26 February 2013).
Carlbring 2012a {published data only}
- Per Carlbring. Internet‐based treatment of generalized anxiety disorder. http://clinicaltrials.gov/ct2/show/NCT01570374 (accessed 1 May 2013).
Carlbring 2012b {unpublished data only}
- Per Carlbring. An Internet‐administered, mindfulness training program for the treatment of anxiety. http://clinicaltrials.gov/ct2/show/NCT01577290 (accessed 1 May 2013).
Clark 2012 {published data only}
- Clark DM. A randomised controlled trial of internet‐based cognitive therapy (iCT) and standard cognitive therapy (CT) for social anxiety disorder. http://www.controlled‐trials.com/ISRCTN95458747 (accessed 1 May 2013). [DOI: 10.1186/ISRCTN95458747] [DOI]
Havik 2012 {published data only}
- Havik OE. Treatment of social phobia and panic disorder in adults (TSPPA). http://clinicaltrials.gov/ct2/show/NCT00619138 (accessed 1 May 2013).
Hedman 2012 {unpublished data only}
- Hedman E. Cognitive behavioral therapy, guided self help versus individual therapy. http://clinicaltrials.gov/ct2/show/NCT01667822 (accessed 1 May 2013).
Hedman 2013 {unpublished data only}
- Erik Hedman. Internet Treatment for Health Anxiety (HA‐X). http://clinicaltrials.gov/ct2/show/NCT01673035.
ISRCTN73535163 {published data only}
- Health Technology Assessment. Obsessive compulsive treatment efficacy trial (OCTET ) (Project record). www.hta.ac.uk/protocols/200900810001.pdf (accessed 12 June 2013).
- ISRCTN73535163. Obsessive compulsive treatment efficacy trial (OCTET). http://www.controlled‐trials.com/ISRCTN73535163/ (accessed 26 February 2013).
Kok 2012 {published data only}
- Kok RN, van Straten A, Beekman A, Bosmans J, de Neef M, Cuijpers P. Effectiveness and cost‐effectiveness of web‐based treatment for phobic outpatients on a waiting list for psychotherapy: protocol of a randomised controlled trial. BMC Psychiatry 2012;12:131. [DOI] [PMC free article] [PubMed] [Google Scholar]
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