Katon 2001.

Methods	Study design: Randomised controlled trial
Participants	Setting: Primary care Diagnosis: Diagnosis of depression or anxiety and patients at high risk of relapse. The first‐stage screen included the depression section of the telephone Structured Clinical Interview for DSM‐III‐R (SCID), Selection criteria for the second stage interview were either having a high epidemiologic risk of relapse or 4 or more residual major depressive symptoms.  Fewer than 4 DSM‐IV major depressive symptoms and a history of 3 or more episodes of major depression or dysthymia or 4 residual depressive symptoms but with a mean Symptom Checklist (HSCL‐20) depression score of less than 1.0 and a history of major depression/dysthymia. Inclusion criteria: Patients between the ages of 18 and 80 years from 1 of 4 primary care clinics who received a new antidepressant prescription (no prior prescriptions within the last 120 days) from a primary care physician Exclusion criteria: Screening score of 2 or more on the CAGE alcohol screening questionnaire, being pregnant or currently nursing, planning to disenroll from insurance plan within the next 12 months, currently seeing a psychiatrist, having limited command of English, and recently using lithium or antipsychotic medication. Age: Mean 46 years Gender: 74% female Ethnicity: 90% White Country: United States Sample size (randomised): Total participants 386, intervention 194, control 192
Interventions	Intervention: Relapse prevention programme Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care provider (PCP), psychologist, nurse, social worker (CM), psychiatrist (MH specialist) 2) a structured management plan: Patients were provided a book and videotape aimed at increasing patient education and enhancing self‐treatment of their depression. CM assessed clinical status and biopsychosocial history. The intervention aimed to improve long‐term adherence to ADs, increase self‐monitoring and relapse prevention strategies such as early help seeking. Other goals were increasing pleasant activities, exercise, and socializing, and identifying potential high‐risk situations to promote problem‐solving ability, coping, and self‐efficacy for managing depression. Follow‐up telephone calls and personalised mailings monitored progress and adherence to the plan 3) scheduled patient follow‐ups: 2 visits and telephone calls at 1, 4 and 8.5 months after session 2. Personalised mailings at 2, 6, 10 and 12 months 4) enhanced inter‐professional communication: PCPs received intermittent verbal and written consultation about patient progress and a copy of the relapse prevention plan. CMs had weekly supervision with MH specialists Control: Treatment as usual enhanced as PCPs were notified of group allocation
Outcomes	Depression (HSCL): 3, 6, 9, 12 months Medication use: 3, 6, 9, 12 months Quality of Life (mental and physical health): 3, 6, 9, 12 months
Notes	AD: antidepressant; CM: case manager; DSM‐IV: Diagnostic and Statistical Manual fourth edition; HSCL: Hopkins Symptom Checklist; MH: mental health; PCP: primary care provider
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated in blocks of 8
Allocation concealment (selection bias)	Unclear risk	Insufficient information available to assess
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Short‐term loss to follow‐up based on primary depression outcome (HSCL) was: overall 35/386 (9%), 13/194 (7%) intervention and 22/192 (11%) control. Reasons for loss to follow‐up not provided. Used intention‐to‐treat analysis
Selective reporting (reporting bias)	Unclear risk	Insufficient information available to assess
Other bias	Unclear risk	Insufficient information available to assess
Implementation Integrity	Unclear risk	Insufficient information available to assess
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel could not be blinded, outcome likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessor was not aware of treatment allocation