Vera 2010.

Methods	Study design: Randomised controlled trial
Participants	Setting: Primary care Diagnosis: PHQ‐9 and the depression scale of the Hopkins Symptom Checklist (HSCL) used. Meeting DSM‐IV criteria for major depression based on their PHQ‐9 score and a mean item score higher than 1.0 on the HSCL‐20 Inclusion criteria: Aged 18 or older, willing to provide informed consent, and had any of the following health conditions diabetes, hypothyroidism, asthma, hypertension, chronic bronchitis, arthritis, heart disease, high cholesterol, or stroke. Spanish speaking and to have stated an intention to use the clinic as their main source of care in the next six‐month period Exclusion criteria:  Serious suicidal risk or terminal illness, a history of bipolar or psychotic disorder or drug or alcohol abuse. Those receiving mental health treatment or applying for disability benefits Age: Mean 55 years Gender: 76% female Ethnicity: Not stated Country: Puerto Rico Sample size (randomised): Total participants 179, intervention 89, control 90
Interventions	Intervention: Collaborative care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care physician (PCP), counsellor/psychologist (CM), psychiatrist (MH specialist) 2) a structured management plan: CMs provided patient education and offered ADs (Selective Serotonin Reuptake Inhibitor typically sertraline) or CBT (13 sessions with psychologist). CMs participated in the coordination of treatment initiation and monitored treatment adherence, side effects, and clinical response. CMs facilitated communication between the patient, PCP and MH specialist. In the medication treatment option, CMs provided follow‐up based on depression severity. The MH specialist was responsible for prescribing and the CM forwarded recommendations to PCP. In CBT CMs provided mental health specialists with a progress report. Non‐response resulted in a switch of modality or combined treatment 3) scheduled patient follow‐ups: At least fortnightly initially and then monthly for up to six months (telephone or face‐to‐face). Additional contacts scheduled as needed 4) enhanced inter‐professional communication: CMs facilitated communication between the patient, PCP and MH specialist. In the medication treatment, CMs had weekly case conference with MH specialist and forwarded treatment recommendations to the PCP Control: Treatment as usual enhanced as patients were informed of their diagnosis and the mental health resources available. The CM encouraged patients to discuss depression treatment options with their PCP. A note was placed in the patient’s medical record to notify PCPs
Outcomes	Depression (HSCL): 6 months Medication use: 6 months
Notes	CM: case manager; HSCL: Hopkins Symptom Checklist; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire‐9
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated in blocks of 20
Allocation concealment (selection bias)	Low risk	Centrally prepared and opened numbered opaque envelopes
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Short‐term loss to follow‐up based on primary depression outcome (HSCL) was: overall 12/179 (7%), 6/89 (7%) intervention and 6/90 (7%) 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