Design and Methods for a Pilot Study of a Phone-Delivered, Mindfulness-Based Intervention in Patients with Implantable Cardioverter Defibrillators
Elena Salmoirago-Blotcher, James Carmody, Gloria Y. Yeh, Sybil L. Crawford, Lawrence Rosenthal, Ira S. Ockene
Evidence-based Complementary and Alternative Medicine January 1, 2012 DOI: 10.1155/2012/972106 (opens in new tab) via OpenAlex
Summary
AI-generated from the abstractThis 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.
Study at a glance
| Characteristics | Randomized controlled trial (pilot study) Peer reviewed |
|---|---|
| Sample size | 52 |
| Population | Clinically stable outpatients with implantable cardioverter defibrillators (ICDs) within a month of an ICD-related procedure or shock |
| Intervention | plus home practice with a CD for 20 minutes daily |
| Dose | 20 minutes daily home practice |
| Duration | 8-week intervention, assessments at baseline and 9-12 weeks after randomization |
| Topics | Anxiety Meditation |
| Keywords | Psychological intervention Intervention counseling Implantable cardioverter-defibrillator |
| Citations | 12 |
| Key finding | The paper describes the design and methods of a pilot study testing the feasibility of a phone-delivered mindfulness-based intervention for anxiety in ICD patients; no results are reported. |
Abstract
Background. Meditation practices are associated with a reduction in adrenergic activity that may benefit patients with severe cardiac arrhythmias. This paper describes the design and methods of a pilot study testing the feasibility of a phone-delivered mindfulness-based intervention (MBI) for treatment of anxiety in patients with implantable cardioverter defibrillators (ICDs). Design and Methods. Consecutive, clinically stable outpatients (n = 52) will be screened for study eligibility within a month of an ICD-related procedure or ICD shock and will be randomly assigned to MBI or to usual care. MBI patients will receive eight weekly individual phone sessions based on two mindfulness practices (awareness of breath and body scan) plus home practice with a CD for 20 minutes daily. Patients assigned to usual care will be offered the standard care planned by the hospital. Assessments will occur at baseline and at the completion of the intervention (between 9 and 12 weeks after randomization). The primary study outcome is feasibility; secondary outcomes include anxiety, mindfulness, and number of administered shocks during the intervention period. Conclusions. If proven feasible and effective, phone-delivered mindfulness-based interventions could improve psychological distress in ICD outpatients with serious cardiovascular conditions.