Design and Methods for a Pilot Study of a Phone-Delivered, Mindfulness-Based Intervention in Patients with Implantable Cardioverter Defibrillators
Evidence-based Complementary and Alternative Medicine January 1, 2012 Elena Salmoirago-Blotcher, James Carmody, Gloria Y. Yeh et al. 12 citations
This paper describes the design and methods of a pilot study testing the feasibility of a phone-delivered mindfulness-based intervention (MBI) for anxiety in patients with implantable cardioverter defibrillators (ICDs). Fifty-two clinically stable outpatients will be screened within a month of an ICD-related procedure or shock and randomly assigned to MBI or usual care. MBI patients receive eight weekly individual phone sessions based on awareness of breath and body scan, plus home practice with a CD for 20 minutes daily. Assessments occur at baseline and 9–12 weeks after randomization. Primary outcome is feasibility; secondary outcomes include anxiety, mindfulness, and shocks. The authors propose that if feasible and effective, such interventions could improve psychological distress in ICD outpatients.