This study prospectively examined the role of cognitive behavioral therapy (CBT) in (1) alleviating psychological and somatic distress, and (2) lowering arrhythmic events requiring shocks. Forty-nine of 61 consecutive patients were randomized into therapy (CBT, n = 25) or no therapy (NT, n = 24) and completed a battery of self-report questionnaires at baseline and at 9-month follow-up. CBT was administered at preimplant, predischarge, and at seven routine follow-up visits. Patients were 65 +/- 10 years old, 65% were men, and 92% Caucasian. Eighteen (72%) CBT patients and 18 (75%) NT patients were retained at follow-up. Compared to CBT patients, NT patients reported higher levels of depression (P = 0.046), more anxiety (P = 0.013), more psychological distress (P = 0.015), poorer overall adjustment (P = 0.009), and poorer sexual functioning (P = 0.003). Mean number of shocks did not differ between the CBT and NT groups (2.85 vs 2.30, respectively); however, more patients in the CBT group (61%) than the NT group (33%) received shocks (P = 0.070). At follow-up, a subgroup analysis revealed that the significant differences observed between the CBT and NT groups were attributable to the patients who received shocks in both groups. In conclusion, CBT was associated with decreased depression, decreased anxiety, and increased adjustment for ICD recipients, particularly among those patients receiving shocks. CBT can be administered effectively at routine follow-up visits or transtelephonically with little added inconvenience to the ICD recipient.