Ross 2008.

Methods	Study design: Cluster‐randomised controlled trial
Participants	Setting: Primary care Diagnosis: PHQ scores ranging from 0–16 without a diagnosis of major depression or other severe axis 1 disorders. Minor depression (those with 2, 3, or 4 Diagnostic and Statistical Manual depression criteria) and those with distress or depressive symptoms not meeting minor depression criteria. Measured with the PHQ‐9 for depression; the MINI International Neuropsychiatric Interview modules for mania, psychosis, panic disorder, generalised anxiety disorder (GAD), PTSD, and alcohol abuse/dependence Inclusion criteria: Clinical concern generated by the PCP and on the results of the Behavioural Health Laboratory assessment. Subjects were eligible for inclusion if they were referred by their PCP for a behavioural health concern and did not meet for any exclusion criteria. Exclusion criteria: Current PTSD, panic disorder, alcohol dependence, suicidal ideation, illicit drug use (past year), or if they had a history of or current bipolar or psychotic disorder. Subjects were also excluded if they were being followed by a MH clinician or if they were currently taking any antidepressants benzodiazepines, antipsychotics, addiction medications, or mood stabilisers Age: Mean 59.2 (SD 15.9) years Gender: 7% female Ethnicity: 43% white Country: United States Sample size (randomised): Total clusters unclear (54 practitioners but randomised by clinic); Total participants 223, intervention 130, control 93
Interventions	Intervention: Telephone close monitoring programme Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care clinician (PCP), nurse (CM), psychiatrist (MH specialist) 2) a structured management plan: Telephone contacts were manualised and included recommending the PCP initiated ADs and CMs frequent monitoring of adverse effects, adherence and depressive symptoms. CMs also provided support and education about depressive disorders and for any other MH problems the CM formulated an appropriate treatment plan which could include referral to specialty care or care management for anxiety. 3) scheduled patient follow‐ups: 5 calls in 12 weeks (at weeks 2, 4, 6, 9, 12) 4) enhanced inter‐professional communication: CMs recommended PCPs initiate ADs and received supervision from MH specialist. Control: Treatment as usual enhanced as all subjects were assessed by the Behavioural Health Laboratory and PCPs were given a report with suggestions for ongoing monitoring of depressive symptoms and had the option to request referral of patients to a mental health clinic. Patients received a letter following assessment that included self‐help advice for any significant depression symptoms and encouragement to discuss his or her symptoms with PCP
Outcomes	Depression (PHQ‐9): 6 months Medication use: 6 months Quality of Life (mental and physical health): 6 months
Notes	CM: case manager; GAD: generalised anxiety disorder; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire: PTSD: post‐traumatic stress disorder
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information available to assess
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 (PHQ total) was: overall 59/223 (26%), 36/130 (28%) intervention and 23/93 (25%) control. Reasons for loss to follow‐up provided, with similar reasons for missing data across groups. Intention‐to‐treat analysis reported, no description of methods to manage missing data
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	Unclear risk	Insufficient information available to assess