Female-Specific Education, Management, and Lifestyle Enhancement for Implantable Cardioverter Defibrillator Patients: The FEMALE-ICD Study LAUREN D. VAZQUEZ, PH.D.,* JAMIE B. CONTI, M.D.,† and SAMUEL F. SEARS, PH.D.‡ From the *Department of Behavioral Medicine, Brooks Rehabilitation Hospital, Jacksonville, Florida; †Division of Cardiovascular Medicine, University of Florida, Gainesville, Florida; and ‡Departments of Psychology and Cardiovascular Sciences, East Carolina University, Greenville, North Carolina Background: Significant rates of psychological distress occur in implantable cardioverter defibrillator (ICD) patients. Research has demonstrated that women are particularly at risk for developing distress and warrant psychosocial attention. The major objectives were to implement and test the effectiveness of a female-specific psychosocial group intervention on disease-specific quality of life outcomes in outpatient female ICD recipients versus a wait-list control group. Method: Twenty-nine women were recruited for the study. Fourteen women were randomized to the intervention group and participated in a psychosocial intervention focused on female-specific issues; 15 were randomized to the wait-list control group. All women completed individual psychological batteries at baseline and at 1-month follow-up measuring shock anxiety and device acceptance. Results: Pre-post measures of shock anxiety demonstrated a significant time by group interaction effect with the intervention group having a significantly greater decrease (Pillai’s trace = 5.58, P = 0.026). A significant interaction effect (Pillai’s trace = 5.05, P = 0.046) was found, such that women under the age of 50 experienced greater reduction in shock anxiety than their middle-aged cohorts. Pre-post measures of device acceptance revealed a significant time by group interaction effect with the intervention group having significantly greater increases (Pillai’s trace = 5.80, P = 0.023). Conclusions: Structured interventions for female ICD patients involving ICD-specific education, cogni- tive behavioral therapy strategies, and group social support provide improvements in shock anxiety and device acceptance at 1-month re-assessment. Young women appear to be an at-risk subgroup of this pop- ulation and may experience more benefit from psychosocial treatment targeting device-specific concerns. (PACE 2010; 33:1131–1140) implantable cardioverter defibrillator, women, psychosocial intervention, anxiety, device acceptance This project was supported in part by Grant Number F31HL083764 from the National Heart, Lung, and Blood Insti- tute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health. Dr. Vazquez has received speaker honorarium from Medtronic. Dr. Sears serves as a consultant to Medtronic and has or has had research grants from Medtronic and St. Jude Medical and has received speaker honorarium from Medtronic, Boston Sci- entific, St. Jude Medical, and Biotronik. Dr. Conti serves as a consultant to Medtronic and has or has had research grants from Medtronic and St. Jude Medical and has received speaker honorarium from Medtronic, Boston Scientific, and St. Jude Medical. Address for reprints: Lauren D. Vazquez, Ph.D., Department of Behavioral Medicine, Brooks Rehabilitation Hospital, 3901 University Blvd South, Jacksonville, FL 32216. Fax: 904-345- 7255; e-mail: Lauren.Vazquez@brookshealth.org Received November 12, 2009; revised February 12, 2010; ac- cepted March 12, 2010. doi: 10.1111/j.1540-8159.2010.02787.x Introduction The implantable cardioverter defibrillator (ICD) is the treatment modality of choice for pa- tients at risk for sudden cardiac death (SCD) and has proved superior to medication alone in large- scale trials. 1–6 Despite the success of the ICD in preventing premature mortality in at-risk patients, the psychological effects of living with an ICD can be considerable, with estimates of clinical levels of anxiety and depression at 13–38% and 9–15%, respectively. 7 Quality of life (QOL) research has re- vealed that ICD recipients report the same or better levels of QOL, compared to patients treated with anti-arrhythmics alone. 8,9 However, ICD patients also experience concerns with the potential for shock, 10 their potential mortality, 11 how the de- vice interferes with socialization, 9 and concerns with sexual functioning. 9 Specific at-risk groups of ICD recipients have been identified and include patients who are female, under the age of 50, and those with a history of shock. 12 While the unequiv- ocal impact of ICD implantation on these groups C 2010, The Authors. Journal compilation C 2010 Wiley Periodicals, Inc. PACE, Vol. 33 September 2010 1131