Katon 1996b.

Methods	Study design: Randomised controlled trial
Participants	Setting: Primary care Diagnosis: Diagnosed by PCP as meeting criteria for definite or probable major depression and who scored 0.75 or greater on the Symptom Checklist (HSCL‐20).  Stratified into moderate and severe depression groups based on their HSCL‐20 score (moderate, 0.75 to < 1.75, severe, 1.75 to 4.0). Inclusion criteria: Aged 18 to 80 years, willingness to take antidepressant medication Exclusion criteria: Current alcohol abuse, current psychotic symptoms, serious suicidal ideation or plan, dementia, pregnancy, terminal illness, limited command of English and plan to withdraw from the insurance plan within the next 12 months Age: Mean 44 years Gender: 75% female Ethnicity: Not stated Country: United States Sample size (randomised: Major depression): Total participants 65, intervention 31, control 34
Interventions	Intervention: Multifaceted intervention programme Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care provider (PCP), psychologist (CM), psychiatrist (MH specialist) 2) a structured management plan: Programme involved teaching cognitive behavioural skills to manage depression and counselling to improve medication adherence. Sessions 1‐4 involved education, skills training, and homework assignments or behavioural experiments. Optional sessions (5 & 6) involved skills training, problem‐solving, and relaxation training. A relapse prevention plan was also developed. Patients received a brief booklet on the biology of depression, the mechanism of action of ADs, a second booklet on simple CBT techniques and a videotape covering similar material. Non‐response patients could be referred to the MH specialist for direct visit. 3) scheduled patient follow‐ups: 4‐6 contacts within 6 weeks and 4 telephone calls at 2, 4, 12 and 24 weeks 4) enhanced inter‐professional communication: Case‐by‐case consultation occurred between CM and PCP and CM's provided PCPs with a handwritten consultation note after each patient contact. A copy of the relapse prevention plan was put in the patient's medical notes. CM and MH specialist met weekly for supervision and CM recommended medication changes (which had been made by the MH specialist) to the PCP. Control: Treatment as usual
Outcomes	Depression (HSCL): 4 months Medication use: 1, 4, 7 months Satisfaction: 4 months
Notes	AD: antidepressant; CM: case manager; 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 50% improvement) was: overall 10/65 (15%), 5/31 (16%) intervention and 5/34 (15%) 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	High risk	Reported analysis not by randomised group but by participants with a) minor and b) major depression.
Implementation Integrity	Low risk	Attempts were made to assess implementation integrity (e.g. direct observation or rating of tapes)
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