Irvine 2011.

Methods	Design: multisite RCT
Participants	Setting: 2 hospitals following ICD transplant Type of trauma exposure: surgery for ICD transplant Inclusion criteria: patients who received their first ICD implant for secondary prevention of sudden cardiac death or primary prevention of sudden cardiac death and if their underlying heart disease was hypertrophic cardiomyopathy. Exclusion criteria: insufficient English fluency; medical chart documented evidence of dementia, cognitive impairment or psychosis; ICD implant for primary prevention of sudden cardiac death due to coronary heart disease, Ischaemic cardiomyopathy and congestive heart failure. The latter were excluded because of concerns that their poor and declining heart function might confound evaluation of the CBT. Sample size: 292 patients were eligible to take part in this study, 193 consented and were randomised. Mean age: 64.4 (SD 14.3) years Gender: 159 (82.4%) men; 34 (17.6%) women Ethnicity: not reported Country: Canada
Interventions	Group 1: telephone‐based CBT: n = 96 Based on the cognitive theory of anxiety (Salkovskis 1996). Content tailored to specific misconceptions that have been known to cause distress in cardiac and ICD patients and it was informed by our clinical work. It included a therapist manual, 8 telephone counselling sessions, a psychoeducational booklet for the participants and a CD with mindfulness‐based exercises and a progressive muscle relaxation exercise. Ad hoc counselling sessions were offered to participants who experienced an ICD shock. Group 2: TAU: n = 97 Whatever the respective ICD treatment sites routinely offered their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow‐up appointments included device interrogation (i.e. to extract arrhythmia events and ICD therapies) and troubleshooting at 6‐month intervals, cardiac care as necessary and non‐systematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation programme and psychiatric consultation as needed.
Outcomes	PTSD: IES‐R Other: HADS; phobic anxiety sub scale of the Crown‐Crisp Experiential Index; Physical Component Summary and the Mental Component Summary of the SF‐36 Follow‐up: 6 and 12 months' postbaseline
Notes	8 participants died during the study. Missing values were not imputed by the study authors for participants who died over follow‐up, as the cause of death was assumed to be non‐random and potentially related to the phenomenon under study.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random numbers program used to randomise participants to the CBT or TAU condition within 4 blocking variables.
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Follow‐up questionnaires were mailed to participants 6 and 12 months after baseline and included a prestamped return envelope.
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT approach employed for the treatment outcome analyses.
Selective reporting (reporting bias)	Low risk	Results reported as described in preregistered protocol.
Other bias	Unclear risk	Evaluation of treatment adherence not reported.