A Randomized Controlled Trial of Cognitive Behavior Therapy Tailored to Psychological Adaptation to an Implantable Cardioverter Defibrillator
- Jane Irvine
- Jill Firestone
- Lephuong Ong
- Robert Cribbie
- Paul Dorian
- Louise Harris
- Paul Ritvo
- Joel Katz
- David Newman
- Doug Cameron
- Sabine Johnson
- Ana Bilanovic
- Ann Hill
- Suzan O'Donnell
- Samuel Sears
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 = 96) or usual cardiac care (n = 97). Eighty percent were male; mean age was 64.4 years (standard deviation = 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 < .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 < .05) and significantly greater improvement in depressive symptoms and Short Form-36 Mental Component Summary only in women (p < .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.
