Pilot: Mind–Body Interventions Enhance Coping by Patients with Paroxysmal Atrial Fibrillation
Key findings
- The SMART Program, long established at Massachusetts General Hospital, includes training in mind–body skills, stress awareness tools, healthy lifestyle behaviors and cognitive reappraisal and adaptive coping skills
- This pilot trial investigated whether the SMART Program, delivered virtually prior to the COVID-19 pandemic, could improve quality of life for patients with paroxysmal atrial fibrillation (AF) and reduce anxiety and depression
- 18 patients (average age 66, 78% female) were randomly assigned 1:1 to join the SMART Program immediately or three months later
- On validated questionnaires participants noted significantly improved AF-related quality of life and reduced depressive symptoms but no significant change in anxiety
- The largest effects of the program were improvements in stress reactivity/coping and increases in positive affect
Several studies, including randomized, controlled trials, suggest that teaching mind–body interventions to patients with paroxysmal atrial fibrillation (PAF) reduces stress, improves quality of life and possibly reduces atrial fibrillation (AF) frequency. Such interventions include yoga, meditation, mini relaxations and mindfulness.
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Over the past decade, researchers at Massachusetts General Hospital have published extensively about its Stress Management and Resiliency Training: Relaxation Response Resiliency (SMART) Program, which has been shown to improve quality of life and symptoms in multiple patient populations.
In Heart Rhythm O2, Michelle L. Dossett, MD, PhD, MPH, former physician and clinical researcher at Mass General, now an assistant professor at UC Davis, John W. Denninger, MD, PhD, director of research at the Benson-Henry Institute for Mind Body Medicine at Mass General, and Jeremy N. Ruskin, MD, founder and director emeritus of the Telemachus & Irene Demoulas Family Foundation Center for Cardiac Arrhythmias at the Corrigan Minehan Heart Center at Mass General and professor of Medicine at Harvard Medical School, and colleagues report similar findings from a pilot trial of the SMART Program that involved patients with PAF.
Study Cohort
Key eligibility criteria for this randomized, waitlist-controlled trial were age 18–90 years and stable medical therapy for recurrent symptomatic PAF. 18 patients (average age 66, 78% female) were randomly assigned 1:1 to join the SMART Program immediately or three months later.
Study Intervention
The SMART Program is a manualized psychoeducational program that includes training in mind–body skills, stress awareness tools, healthy lifestyle behaviors and cognitive reappraisal and adaptive coping skills. Group sessions, held weekly for 1.5 hours for eight weeks, include didactic components, experiential exercises and small-group activities.
During this trial, participants were particularly encouraged to use a relaxation exercise if they developed cardiac symptoms to decrease both autonomic dysregulation and any attendant anxiety.
The groups were scheduled in the evening during the workweek and met online using a secure telehealth platform. They were led by a single physician experienced in running the program.
Outcome Measures
Participants completed 12 questionnaires at baseline and three months later (the waitlist group also completed them six months after baseline). The primary outcomes were changes across all participants in scores on the:
- Atrial Fibrillation Effect on Quality of Life Questionnaire
- Generalized Anxiety Disorder–7
- Personal Health Questionnaire Depression Scale
Other measures included:
- Atrial Fibrillation Symptom Severity and Burden Questionnaire
- Distress Scale
- Positive affect portion of the Positive and Negative Affect Scale
- Measurement of Current Status–A (measures stress reactivity/coping)
Pre–Post Intervention Changes
Of the primary outcomes, participants noted significant improvement only in quality of life:
- AF-related quality of life: Mean score, 74.7 before intervention and 85.8 after (P=0.005; Cohen's d=0.75)
- Depression: 4.8 and 2.9 (P=0.05; d=0.50)
- Anxiety: 7.7 and 5.4 (P=0.155; d=0.35)
There was significant improvement, with moderate to large effect sizes, in:
- AF symptom severity: 12.6 and 9.2 (P=0.03; d=0.59)
- Distress: 5.1 and 3.3 (P=0.01; d=0.64)
- Positive affect: 34.4 and 38.3 (P=0.003; d=0.81)
- Stress reactivity/coping: 23.4 and 31.7 (P=0.001; d=0.97)
Feasibility of Virtual Delivery
The trial was conducted prior to the COVID-19 pandemic when telehealth visits were relatively novel. Even so, the technology was not a substantial barrier to participation and probably enhanced attendance. Only five of 120 potential subjects screened lacked computer/technology access, and on average participants completed 7.2 of the eight visits.
In contrast, a prior pilot trial was difficult to enroll because patients were unable or unwilling to travel to the hospital weekly.
A study coordinator worked with each participant prior to the first session to help them download the required software and gain comfort in using the virtual environment. Several participants had low computer literacy and needed more extensive training, but they successfully engaged with the online program.
The effect size and statistical significance of some of the changes observed in this study are particularly notable given the fact that this was a pilot study with a very small sample size.
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