The ICD Shock and Stress Management Program: A Randomized Trial of PsychosocialTreatment to Optimize Quality of Life in ICD Patients SAMUEL F. SEARS, PH.D.,* LAUREN D. VAZQUEZ SOWELL, M.S., * EMILY A. KUHL, M.A.,* ADRIENNE H. KOVACS, PH.D.,† EVA R. SERBER, PH.D.,* EILEEN HANDBERG, A.R.N.P., PH.D.,‡ SHAWN M. KNEIPP, A.R.N.P., PH.D.,§ ISSAM ZINEH, PHARM.D.,¶ and JAMIE B. CONTI, M.D.‡ From the *Department of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, Gainesville, Florida; †University Health Network, Toronto, Ontario, Canada, ‡Division of Cardiovascular Medicine, College of Medicine, University of Florida, Gainesville, Florida; §College of Nursing, University of Florida, Gainesville, Florida; and ¶Department of Pharmacy Practice and Center for Pharmacogenomics, College of Pharmacy, University of Florida, Gainesville, Florida Background: Implantable cardioverter defibrillator (ICD) patients potentially face significant psycholog- ical distress because of their risk for life-threatening arrhythmias and the occurrence of ICD shock. Methods: The purpose of this study was to test an ICD stress and shock management program delivered in either a six-week format or a one-day workshop format. This intervention was aimed at reducing psychological (anxiety) and physiological (salivary cortisol) markers of distress in ICD patients. Secondary endpoints included measures of quality of life (QOL) and patient acceptance of device therapy, as well as biological mediators of inflammation (TNFα and IL-6). Results: The ICD stress and shock management program resulted in the reduction of anxiety (P < 0.05) and cortisol levels (P < 0.05) in both the six weekly sessions format and the one-day workshop. Measures of anxiety decreased more rapidly with weekly intervention (P = 0.05). Both formats also resulted in a significant increase in patient acceptance of the ICD (P < 0.01). Follow-up assessment from posttreatment (T2) to four-month follow-up (T4) indicated no significant change in depression scores from posttreatment for all groups taken together, but there was a significant group by time effect, such that the workshop group displayed an increase in depression scores from T2 (M = 8.71, SD = 4.39) to T4 (M = 13.57, SD = 11.90), P < 0.05. Conclusions: These results suggest that structured interventions for shocked ICD patients involving ICD education and cognitive-behavioral strategies can reduce psychological distress and improve quality of life, regardless of format. (PACE 2007; 30:858–864) implantable cardioverter defibrillator, shock, psychological, quality of life, stress Introduction Primary and secondary prevention trials us- ing implantable cardioverter defibrillators (ICDs) have demonstrated survival advantages with the ICD versus medications alone in at-risk patients. 1–6 These results have led to broader indications of ICD use. Importantly, the life-saving proper- ties of ICD shock can prompt significant fear This study was funded by a Grant In Aid from the American Heart Association-Florida-Puerto Rico Affiliate and NIH CO6 Grant RR17568. Address for reprints: Samuel F. Sears, Ph.D., Associate Profes- sor, University of Florida, Department of Clinical & Health Psy- chology, Box 100165 UF Health Science Center, Gainesville, FL 32610. Fax: 352-273-6156; e-mail: ssears@phhp.ufl.edu Received January 24, 2007; revised March 22, 2007; accepted April 17, 2007. and anxiety in ICD patients. 7,8 Research indi- cates that both generalized anxiety and disease- specific anxiety (e.g., arrhythmias, ICD shocks) can result in reductions in quality of life (QOL). 5,9 Since shock is a common experience for ICD pa- tients, interventions targeting anxiety and patient adjustment are critical. Cognitive-behavioral ap- proaches for targeting this distress have demon- strated promising results. 10,11 However, the broad biological and psychological effects of cognitive- behavioral interventions in patients who have experienced shock have not been studied to date. The purpose of this investigation was to test an ICD shock and stress management program (ICD- SSMP) delivered in a six-week format versus a one- day workshop format aimed at reducing psycho- logical and physiological markers of anxiety and improving QOL in ICD patients with a history of shock. C 2007, The Authors. Journal compilation C 2007, Blackwell Publishing, Inc. 858 July 2007 PACE, Vol. 30