Design and Methods for a Pilot Study of a Phone Delivered, Mindfulness-Based Intervention in Patients with Implantable Cardioverter Defibrillators (ICD)
BACKGROUND The Support, Education, and Research in Chronic Heart Failure (SEARCH) study was designed to assess the impact of a mindfulness-based psychoeducational intervention on clinical outcomes, depression, and quality of life in patients with chronic heart failure (CHF). Although research has shown that psychosocial factors including depression are important risk factors for adverse events in patients with CHF, no large clinical trials have investigated the efficacy of psychosocial interventions to reduce these factors in this population. METHODS This was a prospective cohort study of 208 adults with left ventricular ejection fraction < or =40% and CHF geographically assigned to treatment or control groups with follow-up at 3, 6, and 12 months. Treatment groups met weekly for 8 consecutive weeks for training in mindfulness meditation, coping skills, and support group discussion. RESULTS Subjects had a mean age of 61 years, left ventricular ejection fraction 26%, and median New York Heart Association class II. The majority were treated with angiotensin-converting enzyme inhibitors (80%) and beta-blockers (86%). At baseline, patients in the treatment group had more severe CHF with higher New York Heart Association class (P = .0209) and more severe psychological distress (Center of Epidemiology - Depression, Profile of Mood States; P < .05). When compared with controls, treatment resulted in lower anxiety (Profile of Mood States, P = .003), depression (Center of Epidemiology - Depression, P = .05), improved symptoms (Kansas City Cardiomyopathy Questionnaire symptom scale, P = .033) and clinical scores (Kansas City Cardiomyopathy Questionnaire clinical score, P = .024) over time. There were no treatment effects on death/rehospitalization at 1 year. CONCLUSIONS An 8-week mindfulness-based psychoeducational intervention reduced anxiety and depression; this effect was attenuated at 1 year. Importantly, the intervention led to significantly better symptoms of CHF at 12 months compared to control subjects. Our results suggest that interventions of this type might have a role in optimal therapy for CHF.