Cummings 2019.

Study characteristics
Methods	Randomized trial of a tailored cognitive behavioral intervention in type 2 diabetes with comorbid depressive and/or regimen‐related distress symptoms: 12‐month outcomes from COMRADE RCT (NA clusters and NA providers), conducted in 1) The study took place in a large academic family medicine practice in the southeastern US that provides primary care to a large rural population. The practice is a training site for residents, medical students and other learners and delivers care to a diverse population of African American and Caucasian patients. 2) The behavioural intervention was delivered by a team of trained behavioural providers working together, including a nurse care manager who provided small changes lifestyle coaching, a psychologist and clinical health psychology doctoral student who provided CBT sessions including elements of problem‐solving therapy (PST) where indicated, and a community health worker (CHW) who provided navigation and social support. In United States of America. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (CBT: cognitive behavioural therapy, plus lifestyle counselling) (intervention arm)
Participants	Control arm N: 72 Intervention arm N: 67, NA, NA Diabetes type: 2 Mean age: 52.6 ± 6.58 % Male: 22.3 Longest follow‐up: 12 months
Interventions	Control arm: (usual care) 1) Patient education Intervention arm: (CBT: cognitive behavioural therapy, plus lifestyle counselling ) 1) Case management 2) Team change 3) Clinician education 4) Patient education 5) Promotion of self‐management
Outcomes	Glycated haemoglobin Systolic blood pressure
Funding source	The authors acknowledge funding support from East Carolina University
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation used a blocked randomisation process, involving a computer‐generated allocation sequence with allocation concealment from treating providers, with eligible patients randomised in blocks of 4 to the intervention or control group.
Allocation concealment (selection bias)	Unclear risk	Method not reported. Randomisation used a blocked randomisation process, involving a computer‐generated allocation sequence with allocation concealment from treating providers.
Patient's baseline characteristics (selection bias)	Low risk	Table 1. All patient characteristics have P values higher than 0.05. Quote: "Mean age, percent female and percent African American were not significantly different at baseline."
Patient's baseline outcomes (selection bias)	Low risk	Table 1. All outcomes (including HbA1c and SPB) have P values higher than 0.05, except for the medication adherence score (P = 0.036). Quote: "There was a difference in self‐reported medication adherence scores at baseline, with the intervention group reporting modestly lower scores (poorer adherence)."
Incomplete outcome data (attrition bias)	High risk	10/72 lost in the control group (14%) and 9/67 in the intervention group (13%). Quite high numbers and the reasons for loss are not reported.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	HbA1c and SBP were objectively assessed.
Selective reporting (reporting bias)	High risk	Prospectively registered protocol. They do not report DBP. Quote: "The principal outcome measure, change in HbA1c, and secondary continuous outcome measures (e.g., changes in RRD score, PHQ‐9 score, weight, and blood pressure) from baseline to 12 months of follow‐up were compared." They do not report hypoglycaemia events. Quote: "Potential for side effects were monitored approximately quarterly by the nurse care manager during face‐to‐face and telephone follow‐up, with particular attention to the potential for hypoglycaemia associated with insulin and sulfonylurea drugs." In the protocol, they wanted to look at 6 and 12 months follow‐up, but they only report 12 months follow‐up in the paper (Table 2). They added medication adherence score, weight and SBP in the paper.
Risk of contamination (other bias)	Unclear risk	Patient‐randomised. The intervention involves many providers from only one clinic. Unclear whether teams worked with both groups.
Other bias	Low risk	No evidence of other bias.