A mindfulness-based intervention for treatment of anxiety in ICD patients

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DESCRIPTION (provided by applicant): Implantable cardioverter-defibrillators (ICD) have been demonstrated to reduce the risk of cardiac death both in primary and secondary prevenfion trials, but concerns have been raised regarding the quality of life (QOL) and psychological well-being in ICD-implanted patients. Anxiety has been shown to be an independent predictor of mortality in ischemic heart disease raising the possibility that it may play a contributing role in the high one-year mortality rate observed in ICD patients. Mindfulness-based interventions are complex behavioral interventions combining breathing and light yoga exercises that have been shown to reduce anxiety and some physical symptoms in conditions such as cancer, chronic pain, rheumatoid arthritis and fibromyalgia. There is some preliminary evidence that mindfulness-based interventions may reduce anxiety in cardiac patients as well. It is possible to hypothesize that a mindfulness- based training may reduce anxiety in ICD patients and, consequently, lead to a reduction in the number of arrhythmic/cardiac events and ICD-delivered shocks. We decided to test this hypothesis in a pilot study of a phone delivered, mindfulness based intervention compared to usual care in a group of candidates for ICD implantation. This pilot study will provide preliminary data about the feasibility of recruitment, retention, and adherence to a mindfulness based, phone delivered intervention for treatment of anxiety in ICD patients, and preliminary estimates of efficacy on mindfulness level, anxiety, shocks and arrhythmic episodes. The Study will be conducted at UMass Memorial Medical Center (UMMC) in Worcester, MA where more than 300 patients are admitted every year for ICD implantation. All consecutive outpatients will be screened for study participation. Eligible patients will be consented and randomized either to a usual care arm, or to a mindfulness-training arm. A total of 52 patients (26 for each amn) will be enrolled in the study. The intervention will include one in-hospital, one-to-one mindfulness training session, followed by seven weekly, individual, phone-delivered sessions with a certified mindfulness instructor. Anxiety and mindfulness scores will be measured at baseline and 12 weeks after enrollment. Public Health Relevance: This project is relevant to public health because the number of candidates for ICD implantation is rising due to a broadening of indications to include primary prevention of sudden death. The prevalence of anxiety in this population reaches up to 40% in some Studies. A mindfulness-based intervention, adapted to this group of patients, is relatively inexpensive and, once learned, can easily be self-administered by the patient. If proven effective, it could positively impact the quality of life and, possibly, the incidence of arrhythmias and delivered shocks in these patients.