Bertelsen 2008.

Methods	A randomised controlled trial recruiting patients between January 1998 and December 2000 with two year and five year follow‐up. Role of collaborating partners Lead agency: Mental health Strategic involvement (policy making and service planning): Secondary health care Commissioning (implementing strategy taking account of resources available): Primary and secondary health care, social services Operational (providing services directly): Primary and secondary health care, social services Set in Denmark.
Participants	547 patients (275 intervention group, 272 control group) aged between 18 and 45 with a first time diagnosis within the schizophrenia spectrum (F2 category codes of ICD 10) and no history of receiving antipsychotic medication for more than 12 continuous weeks.  Patients were recruited from inpatient and outpatient mental health services in Copenhagen and Aarhus. Of eligible patients only 5% refused to participate.  Male 58% (intervention group) 60% (controls) Mean age 26.6 years in both groups
Interventions	Intensive early‐intervention programme was defined by protocols and consisted of three core elements, Assertive Community Treatment (ACT), family treatment where possible and social skills training where needed.  ACT teams were based at the Copenhagen Hospital Corporation and Psychiatric Hospital, Aarhus and consisted of psychiatrist, psychologist, nurse, vocational therapist and social worker. Psycho‐educational family treatment was provided by a family therapist. Caseload ratio was 1 researcher for every 10 patients. Each intervention patient was allocated a team member responsible for maintaining contact and securing coordination of the treatment across different treatment facilities and across the social and health sectors. Over a two year period patients were offered an individual plan of treatment, regular visits as required, at least weekly, and psycho‐educational treatment lasting 1.5 hours every second week over 18 months. Social skills training was provided if required via modular course. After two years patients returned to standard treatment. Standard treatment for controls and intervention patients after the first 2 years was generally provided at a community mental health centre but in a few cases was a provided by a general practitioner. They may have had contact with social workers. A staff member's caseload in the community mental health centre varied between 20 and 30 patients.
Outcomes	Outcomes were measured at two year (n=369,) and five year (n=301) follow‐up.  Primary outcome measures were symptoms according to the Scale for Assessment of Psychotic Symptoms (SAPS), Scale for Assessment of Negative symptoms (SANS) and the social functioning element of the Global Assessment of Functioning (GAF) scores for symptoms and for function.  Secondary outcomes included secondary diagnosis of substance abuse, medication, use of services, depressive symptoms, suicidal behaviour, housing situation and vocational situation.  Course of illness measure with Life Chart Schedule. Main diagnosis and substance abuse measured by Schedule for Clinical Assessment in Neuropsychiatry (SCAN Version 2.0 in 1998 and 2.1 since 1999).  Duration of untreated psychosis at entry to the trial.  Suicidal behaviour measured by self‐reported suicide attempts and ideation.  Days in hospital, emergency department contacts, outpatient contacts from the Danish Psychiatric Central Register.  Information on independent living and supported housing from the Civil Status Register.  Employment, family situation, sick leave, early‐age pension from the Integrated Database for Labour Market Research.  Mortality and cause of death from the Cause of Death Register.
Notes	Follow‐up at 2 years was unequal, 75% in intervention group and 60% in control group. Follow‐up at 5 years was below 60% in both groups (but above threshold set from power calculation of 142 in each arm). Significant additional resource required to deliver intervention. One of the initial hypotheses was that "Increased co‐operation between the primary health and social sectors leads to reduced duration of untreated psychosis, as knowledge of psychosis and easy access to treatment is essential for co‐workers' referral policy." We were unable to obtain further details from the authors on this point. The fidelity of the treatment programme, measured with the index of fidelity of assertive community treatment, was 70% in Copenhagen and Aarhus. Overall risk of bias was high.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	Computer generated allocation.
Blinding (performance bias and detection bias) All outcomes	High risk	Assessment at 2 year follow‐up was not blinded. Single blind assessment by independent investigator at 5 years but follow‐up rate was below 60% so not reported here.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Estimated mean differences are based on a repeated measurement model, assuming that the distribution of missing data could be estimated from the information from previous interviews.
Selective reporting (reporting bias)	Low risk	Protocol provided in linked paper Jørgensen 2000.
Other bias	High risk	Problems related to potential selection bias.
Randomisation adequately described/protected?	Low risk	Centralised telephone randomisation.
Protection against contamination?	Low risk	Control patients may have had access to social worker but this was part of standard treatment.
Follow‐up rate adequate?	High risk	Follow‐up rates unequal at 2 years (75% in intervention group and 60% in control group). At the end point of the trial at 5 years, follow‐up assessment rates only 56% (intervention group) and 57% (control group) , 57% and 58.8% respectively when adjusted for deaths, so these results were not included in this review.
Reliable primary outcome measure?	Low risk	Scale for Assessment of Positive (SAPS) and Negative (SANS) Symptoms, plus functional GAF (Global Assessment of Functioning) well established and inter‐rater reliability checked.
Groups measured at baseline?	Low risk	Groups approximately balanced
Appropriate choice of controls (CBA studies only)?	Unclear risk	Not applicable
Contemporaneous data collection (CBA studies only)?	Unclear risk	Not applicable
IS THE STUDY AT LOW RISK OF BIAS?	High risk	OVERALL RISK OF BIAS WAS HIGH