Katon 2010a.

Methods	Study design: RCT Unit of randomisation: patient Unit of analysis: patient Funding sources: National Institute of Mental Health; Group Health Cooperative Conflicting interests: fees/grants from Wyeth, Eli Lilly, Forest, Pfizer, Prescott Medical, HealthSTAR Communications, World Psychiatry Association, John A Hartford Foundation, Johnson & Johnson, Samepage, Rewarding Health, Roche Diagnostics, Group Health Cooperative
Participants	Country: USA Setting: Primary care Conditions/numbers: 214 patients with depression + diabetes and/or CHD (106 intervention, 108 control) Health literacy: n/a Multi‐morbidity: yes
Interventions	Theoretical framework: n/a Focus: patient Type of intervention: Structured, face‐to‐face self‐management support + staff training Clinicians involved: Nurses (additional), primary care physicians (usual) Tools: TEAMcare intervention combined support for self care with pharmacotherapy to control depression, hyperglycemia, hypertension, and hyperlipidemia. Participants worked collaboratively with nurses and primary care physicians to establish individualised clinical and self‐care goals. In structured visits at each participant's primary care clinic every 2 to 3 weeks, nurses monitored participant's progress in management of depression, control of medical disease, and self‐care activities. Treatment protocols guided adjustments of commonly used medicines in participants who did not achieve specific goals. Nurses followed participants proactively to provide support for medication adherence. Using motivational interviewing and coaching, nurses helped participants solve problems and set goals for improved medication adherence and self care (e.g. exercising and self‐monitoring blood pressure and glucose levels). Participants received self‐care materials including The Depression Handbook, a video compact disk on depression care, a booklet and other materials on chronic condition management and self‐monitoring devices (e.g. blood pressure or blood glucose meters) appropriate to their condition. Nurses received weekly supervision with a psychiatrist, primary care physician, and psychologist to review new cases and participant progress. Supervising physicians recommended initial choices and changes in medications tailored to the participant's history and clinical response. When targeted levels were reached, the nurse and the participant developed a maintenance plan that included stress reduction, behavioural goals, continued use of medications, and identification of prodromal symptoms associated with worsening depression and glycemic control. Nurses then followed up with telephone calls every 4 weeks. Participants with disease control that worsened were offered follow‐up visits or telephone calls and protocol‐based intensification of treatment regimens. Stages completed: Extended ‐ A, B, C, D, E, F, G Usual provider aware of patient's goals and action plans: Yes Standardisation of clinician input: strong ‐ 2‐day training course attended by the 3 study nurses + educational materials + weekly case‐load reviews with physicians + close monitoring Fidelity: Data and safety monitoring board, numbers of in‐person and phone contacts monitored and reported Attrition: 12% at 6 months and 17% at 12 months lost to follow‐up Comparison: Enhanced usual care
Outcomes	Health status:physical: HbA1c, systolic blood pressure, LDL cholesterol; psychological: Symptom Checklist‐20; Patient Global Rating of Improvement*; subjective: Sheehan social role disability scale, WHO Disability Assessment Schedule (WHODAS‐2), quality of life (0 to 10) (NV) Self‐management capabilities: 4 selected questions from short‐form Patient Activation Measure (PAM‐13) Health behaviours: diet, exercise, medication adherence Achievement of personal goals: n/a Service use: healthcare costs and cost effectiveness, including depression‐free days, QALYs, outpatient costs Adverse events: hospitalisations ‐ 27 intervention, 23 control; deaths: 1 intervention, 2 control. Timing of outcome measures: Baseline, 6 months, 12 months
Notes	*Primary outcome. Power calculation ‐ 290 participants required to detect a clinically significant difference in SCL‐20 depression scores, HbA1c, systolic blood pressure and LDL cholesterol. Only 214 recruited so under‐powered.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomly assigned by computer using a permuted block design with randomly selected block sizes of 4, 6, and 8 patients.
Allocation concealment (selection bias)	Low risk	Research assistants who were unaware of the intervention status implemented study procedures (Katon 2010a)
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Single‐blind only ‐ not possible to blind participants to intervention, but most outcomes objective so unlikely to affect risk of bias.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Clinicians were not blinded to outcome assessments because these were part of the intervention.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Fully detailed in Figure 1 of Katon 2010a
Selective reporting (reporting bias)	Low risk	Protocol published (Katon 2010b). Data and safety monitoring board reviewed methods and outcomes every 6 months. Katon 2010a includes description of pre‐analysis modifications to protocol.
Other bias	Low risk	Intervention provided by research nurses not involved with control group, in collaboration with primary care physicians