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Objectives:To evaluate a eight-session cognitive behavior therapy (CBT) intervention tailored to adaptation in implantable cardioverter defibrillator (ICD) patients; and to test for treatment group by gender interaction effects. Methods: Patients receiving their first ICD implant were randomized to CBT or usual cardiac care. Primary outcomes measured at baseline, 6-month, and 12-month follow-ups were symptoms of anxiety and depression (Hospital Anxiety and Depression Scale), posttraumatic stress disorder symptoms (Impact of Events Scale-Revised), and phobic anxiety (Crown-Crisp Experiential Index). Secondary outcomes were quality of life (Short Form-36 Physical Component Summary and Short Form-36 Mental Component Summary) and ICD shocks or antitachycardia pacing therapies. Results: Of 292 eligible patients, 193 consented and were randomized to CBT (n ϭ 96) or usual cardiac care (n ϭ 97). Eighty percent were male; mean age was 64.4 years (standard deviation ϭ 14.3); and 70% received an ICD for secondary prevention. No baseline differences were observed between the treatment conditions; however, women scored worse than men on all psychological and quality of life variables (p Ͻ .05). Eighty-three percent completed follow-up. Repeated-measures analyses of covariance revealed significantly greater improvement with CBT on posttraumatic stress disorder total and avoidance symptoms for men and women combined (p Ͻ .05) and significantly greater improvement in depressive symptoms and Short Form-36 Mental Component Summary only in women (p Ͻ .01). No differences were observed between treatment conditions on ICD therapies over follow-up. Conclusion: A CBT intervention to assist adaptation to an ICD enhanced psychological functioning over the first year post implant. Trial Registration: clinicaltrials.gov Identifier: NCT00152763. Key words: cognitive behavior therapy, implantable cardioverter defibrillator.ICD ϭ implantable cardioverter defibrillator; ATP ϭ antitachycardia pacing; CBT ϭ cognitive behavior therapy; UCC ϭ usual cardiac care; QL ϭ quality of life; SCD ϭ sudden cardiac death; IES-R ϭ Impact of Events Scale-Revised; PTSD ϭ posttraumatic stress disorder.