OPUS‐Denmark 1999.
| Methods | Allocation: randomised.
Design: multicentre (5 centres, in Copenhagen and Aarhus, data not available for single centres).
Duration: 24 months of active treatments after randomisation. Follow‐up: 5 and 10 years after randomisation (i.e. 3 and 8 years after the active intervention was provided). Starting from 2 years after randomisation, all participants received standard care (both those randomised to the experimental intervention and those randomised to standard care). Country: Copenhagen and Aahrus, Denmark. |
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| Participants | Diagnosis*: schizophrenia or schizophrenia‐like psychosis (according to ICD‐10) (main diagnosis and comorbidity based on SCAN 2.0 and SCAN 2.1). N = 547. Setting: public mental health service. Age: 18 to 45 years, mean 26.6 years. Sex: 59% M (323M, 224F). Ethnicity: not reported. History**: i. prior treatment of mental disorder has not been adequate (i.e. ≦ 12 weeks of continuous antipsychotic medication in antipsychotic dosage), ii. absence of learning disability, organic mental disorder, and psychotic condition due to psychoactive substance use, iii. Danish speaker, iv. written informed consent, v. legal residence in the catchment area, vi. the use of psychoactive drug did not cause exclusion. | |
| Interventions | 1. ICM***: modified Assertive Community Treatment (including individual case manager, recommendation of antipsychotic medications, psycho‐educational family treatment****, and social skill training). Caseload: 1:15. N = 275. 2. Standard care***: treatment in a CMHC. Caseload: 1:20‐30. N = 272. | |
| Outcomes | Service use: average number of days in hospital per month; not in contact with service, defined as "an unplanned break of at least 30 days in treatment or between treatment regimens or status (i.e. from discharge to outpatient status)"; admitted to hospital (during previous 12 months); proportion not hospitalised; proportion without outpatient contacts; proportion without psychiatric emergency room contacts.
Death: all causes, suicide.
Global state: leaving the study early.
Social functioning: not working or in education, not living independently, alcohol and drug abuse diagnosed with SCAN, contact with the legal system ‐ imprisonment (2‐year treatment and 3‐year follow‐up), number of days in supported housing, number of days in a homeless shelter.
Mental state, specific symptoms: positive symptoms (Scale for Assessment of Positive Symptoms ‐ SAPS), negative symptoms (Scale for Assessment of Negative Symptoms ‐ SANS), comorbidity with depression.
Participant satisfaction: Client Satisfaction Questionnaire (CSQ).
Behaviour: specific behaviour, self harm (measured by self reporting of suicide attempts). Unable to use ‐ Global state: compliance with medications: defined "good compliance" as having taken the prescribed antipsychotic medications in the recommended doses regularly during previous 3 months (not reported), GAF (reported only subscale data, not global score). Social functioning: Social Network Size (not published measure instrument), Social Network Schedule (SNS); various outcomes on accomodation status (as proportion spending at least 1 day in supported housing or in homeless shelter): not listed as a review outcome of interest. Mental state, specific symptoms: disorganised dimension (not stated how it is measured) and suicidal ideation (not listed as a review outcome of interest). Quality of life: not reported. Participant satisfaction: Camberwell Assessment of Need (CAN) (not reported). Relative satisfaction: Client Satisfaction Questionnaire 8‐item, adapted version (not reported). Behaviour: Social Behaviour Assessment Schedule (SBAS) (reported only score on subscale). Use of coercive measure: not listed as a review outcome of interest. Assessment of expressed emotion: not listed as a review outcome of interest. |
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| Notes | *Schizophrenia 66%; schizotypal disorder ˜ 15%; schizoaffective disorder ˜ 5%. **Median duration of untreated psychosis ˜ 50 weeks. ***In both interventions use of antipsychotics followed the guidelines from the Danish Psychiatry Society (recommending a low‐dose strategy for patients with first‐episode psychosis and the use of second‐generation drugs as first choice). ****Family treatment followed McFarlane's manual for psychoeducational treatment for multiple‐family group (18 months' treatment, 1.5 hours twice a week, in a multiple‐family group with 2 therapists and 4 to 6 patients with their families). Focus on problem solving and development of skills to cope with illness. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised. In Copenhagen, allocation sequence was computer generated. In Aahrus, a secretary drew a lot among 5 red and 5 white lots from a black box. Central randomisation. Randomisation was 1:1, in block of 6, stratified for each of the 5 centres. |
| Allocation concealment (selection bias) | Low risk | In Copenhagen, randomisation was carried out through centralised telephone allocation. In Aahrus, researchers were informed on the randomisation assignment after they had finished the entry assessment. Block sizes were unknown to investigator. |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Primary outcome: clinician/participant mediated ‐ rating ‐ Unclear. Secondary outcome: those interviewer rated ‐ rating ‐ No. Reported: "Investigators were not blind to treatment allocation". |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Problematic to blind participants and those providing the intervention in studies comparing ICM intervention with standard care. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Service use based on official registers, blinding not reported. Interviewers for mental state unblinded. Client satisfaction, suicide attempts, and suicidal ideation self reported. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Numbers and reasons for missing data are clearly reported. Analysis was conducted on an ITT basis. |
| Selective reporting (reporting bias) | High risk | Authors reported change of primary outcome stated in the protocol (from "relapse and positive symptoms" to "psychotic and negative symptoms"), as high attrition occurred in the former outcome measurements. Some listed outcomes of interest are not reported. |
| Other bias | Low risk | Publicly funded. No declaration of interest. No further details. No evidence of the presence of other bias. |