TREATED‐ACS 2020.

Study characteristics
Methods	RCT design: 2‐arm parallel‐group trial Total N randomised: 100 Length of follow‐up: 30 months Analysis: ITT and imputation not specified (8 dropouts from intervention group, 10 dropouts from CM group)
Participants	Location: Italy Number of study centres and setting: Maggiore Hospital in Bologna and San Giovanni Battista Hospital in Torino CAD criteria: first episode of acute MI or unstable angina. MI defined by cardiac symptoms (presence of acute chest, epigastric, neck, jaw, or arm pain or discomfort or pressure without apparent non‐cardiac source) and signs (acute congestive heart failure or cardiogenic shock in the absence of non‐CHD causes) associated with ECG findings (characteristic evolutionary ST‐T changes or new Q waves) and/or cardiac biomarkers (blood measures of myocardial necrosis, specifically CK, CK‐MB, CK‐MBm, or troponin, cTn). Unstable angina defined by cardiac symptoms (chest pain lasting less than 20 minutes) with likely ECG findings (ST‐segment depression and abnormal T‐wave) in the absence of myocardial necrosis biomarkers Depression criteria: a current diagnosis of at least 1 of the following: major or minor depression, dysthymia according to DSM‐IV criteria, and demoralisation according to Diagnostic Criteria for Psychosomatic Research criteria Other entry criteria: Mini‐Mental State Examination score higher than 24, written informed consent provided by the patient to participate Exclusion criteria: history of bipolar disorder (DSM‐IV criteria), major depression with psychotic features, history of substance abuse or dependency during the previous 12 months, serious suicide risk, current use of antidepressants, current treatment with any form of psychotherapy
Interventions	Intervention 1: CBT in combination with WBT and lifestyle modification. CBT involves: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping participants to engage in enjoyable activities more often (behavioural activation); enhancing problem‐solving skills; providing instruction and guidance in specific strategies for solving problems. WBT involves techniques to overcome impairments in environmental mastery, purpose in life, personal growth, autonomy, self‐acceptance, and positive relations with others. Lifestyle modification not further specified. Intervention 2: clinical management, consisting of reviewing the participant's clinical status and providing the participant with support and advice if necessary
Outcomes	Primary: depression symptoms measured by Paykel's 20‐item change version of the Clinical Interview for Depression (CID). Depressive symptoms subscale of Kellner's Symptom Questionnaire Secondary outcomes: frequency of negative cardiac outcomes, such as rehospitalisations due to cardiac complications, acute MI, unstable angina, angioplasty, cardiac surgery, and cardiac mortality occurring after the first episode of ACS
Funding	Compagnia di San Paolo di Torino, Italy
Notes	https://clinicaltrials.gov/ct2/show/NCT00998400
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: Treatment allocation was accomplished through random computerized assignment that allocated 50% of the patients to each treatment group, not further specified
Allocation concealment (selection bias)	Unclear risk	Comment: Assignment concealed until the time of group assignment, not further specified
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: Outcomes included self‐report and structured interviews, as well as biomarkers. Assignment concealed until the time of group assignment; blinding not further specified
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: Patients were assessed by 2 clinical psychologists, who were blind to treatment assignment, at pretreatment and posttreatment, and 3, 6, 12, and 30 months after the end of treatment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: 2 of 48 patients in each group dropped‐out from baseline to end of treatment, and 22 patients total dropped‐out before 30‐month follow‐up Comment: All analyses were performed by using intention‐to‐treat analysis, where missing values were managed by means of a multiple‐imputations procedure
Selective reporting (reporting bias)	Low risk	Comment: All outcomes stated in the methods section and trial registry NCT00998400 were reported Comment: Biomarker analyses included in the paper were not stated in the trial registry NCT00998400 Comment: No design paper available
Other bias	Unclear risk	Comment: exact p values not reported for baseline comparisons between intervention groups. Possible imbalance at baseline, psychotherapy group taking less cardiac medications and reporting more personal growth; psychotherapy group reporting more depression + demoralisation Comment: therapists trained in intervention; no efforts regarding therapy quality mentioned