Gensichen 2009.

Methods	Study design: Cluster‐randomised controlled trial
Participants	Setting: Primary care Diagnosis: Diagnosis of major depression with indication for any antidepressive treatment.  Diagnosis of major depression was based on a score of more than 9 points and a categorical diagnosis in the PHQ‐9, and was confirmed by the family physician by using the checklists in the Diagnostic and Statistical Manual of Mental Disorders (DSM‐IV), and International Classification of Diseases (ICD‐10). Inclusion criteria: Age 18 to 80 years, access to a private telephone, ability to give informed consent, and ability to communicate in German Exclusion criteria: Confirmed pregnancy, severe alcohol or illicit drug consumption, or acute suicidal ideation assessed by the family physician Age: Mean 51.1 years Gender: 76% female Ethnicity: Not stated Country: Germany Sample size (randomised): Total clusters 74, intervention 35, control 39; Total participants 626, intervention 310, control 316
Interventions	Intervention: Case management Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Family physician (PCP), healthcare assistant (CM) 2) a structured management plan: CMs monitored depression symptoms and adherence to medication using a protocol. Having been trained in behavioural activation CMs encouraged patients to follow self‐management activities, such as medication adherence and activation for pleasant or social activities 3) scheduled patient follow‐ups: 19 telephone contacts twice weekly for first month then monthly for 11 months 4) enhanced inter‐professional communication: CMs provided PCP with information on patient's in a structured report Control: Treatment as usual enhanced as PCPs received training on evidence‐based depression treatment guidelines
Outcomes	Depression (PHQ‐9): 6,12 months Medication use: 12 months Quality of Life (mental and physical health): 12 months Satisfaction: 12 months
Notes	CM: case manager; 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
Allocation concealment (selection bias)	High risk	Central randomisation of clinic. Those recruiting patients were aware of allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Short‐term loss to follow‐up based on primary depression outcome (PHQ‐9) was: overall 71/626(11%), 43/310 (14%) intervention and 28/316 (9%) control. Reasons for loss to follow‐up provided, with similar reasons across groups. Used intention‐to‐treat analysis
Selective reporting (reporting bias)	Low risk	Protocol available and all prespecified outcomes reported
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	High risk	Assessor was potentially aware of treatment allocation