McLaughlin 2005.

Study characteristics
Methods	RCT design: 2‐arm parallel‐group trial Total N randomised: 100 Length of follow‐up: 4 months Analysis: per‐protocol (8 treatment participants dropped out, 12 control participants dropped out)
Participants	Location: USA Number of study centres and setting: patients with ACS from 2 hospitals CAD diagnosis: ACS assessed by medical chart review in the coronary care unit; time to randomisation not specified Depression diagnosis: score of 7 and more on either subscale of the HADS Other entry criteria: 35 years of age or older, able to speak English, access to a touch‐tone phone Exclusion criteria: mental health care in the prior 3 months, psychoactive drug use during the past year, and diagnosis of substance abuse during the past year Treatment N: 45 (31.1% female, mean age: 59.9 (SD: 10.2)) Control N: 34 (35.3% female, mean age: 60.7 (SD: 9.8)) Comparability of the groups: significantly higher anger scores amongst females in the treatment group, significantly more participants with MI in the treatment group
Interventions	Treatment: 6 telephone counselling sessions (30 minutes each) with clinicians (psychiatrist, clinical psychologist, internist) comprising review of common fears experienced by those living with chronic medical conditions and identification and management of barriers to adjustment to medical illness; participants with HADS score > 15 were referred for emergent care Control: usual care (received a booklet on coping with cardiac illness typical of those given at hospital discharge and were instructed to contact their primary care physician if they experienced any warning signs of depression; advised to continue follow‐up with their primary care and specialist physicians) Duration of treatment: 8 weeks
Outcomes	Review outcomes: depression symptoms (HADS), all‐cause mortality Other outcomes: anxiety symptoms (HADS), Work and Social Adjustment Scale (WSAS), State‐Trait Anger Expression Inventory (STAXI), clinical global impressions
Funding	National Institute of Mental Health, USA; Robert Wood Johnson Foundation
Notes	Mixed study sample (patients with depression and/or anxiety)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "by coin flip" (p. 1085 in McLaughlin et al., 2005)
Allocation concealment (selection bias)	High risk	Quote: "The study coordinator conducted the coin flip and assigned patients to a treatment arm when she contacted study participants by telephone and enrolled consenting participants." (p. 540 in Bambauer et al., 2005)
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: No sufficient information provided
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: Primary outcome was patient self‐report measure (HADS); other blinding not stated
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: The authors describe that multiple imputation methods were used to examine if data were missing at random. But all analyses were reported for the final cohort of 79 patients
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol and design paper available Comment: outcomes consistent in methods and results sections
Other bias	Unclear risk	Comment: weekly meetings and supervision of counsellors; monitoring quality not otherwise specified Comment: depression data reported as β value unit change and final HADS depression scores post‐treatment