A SMART Approach to Reducing Atrial Fibrillation Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in anxiety symptoms as measured by the generalized anxiety disorder 7 item questionnaire (GAD-7).
研究概览
简要总结
This is a pilot study to test the effects of the SMART-3RP (Stress Management and Resiliency Training Relaxation Response Resiliency Program) on quality of life, mental health, arrhythmia burden, and heart rate variability (HRV) in patients with paroxysmal atrial fibrillation (PAF).
详细描述
Mind-body practices that elicit the relaxation response (RR) have been used worldwide to prevent and treat disease. The Stress Management and Resiliency Training - Relaxation Response Resiliency Program (SMART-3RP) is an 8-week manualized psycho-educational program that incorporates RR methods such as meditation or seated yoga along with cognitive skills building and lifestyle approaches to increase resiliency to stress. This study will use a randomized, wait-list controlled trial design to test the effects of the SMART-3RP on quality of life (QoL), mental health, arrhythmia burden, and HRV in patients with PAF. The program will be delivered virtually (via computer video conferencing), questionnaires will be completed, and physiological data as well as blood will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with documented recurrent symptomatic PAF.
- •Currently on stable medical therapy for AF and willing to continue on the same treatment regimen while participating in the study.
- •No current daily practice of yoga, meditation, guided imagery or other techniques that elicit the RR.
- •Able to provide informed consent and to understand written and spoken English.
排除标准
- •Allergy to adhesives that prevents wearing the HRV monitor.
- •Patients unable or unwilling to participate in an intervention delivered via video conferencing.
- •End Stage renal failure or heart failure, severe unstable medical or psychiatric disease.
- •Patients deemed unable to complete protocol due to cognitive or other reasons.
- •Patients on psychoactive medications will have eligibility determined by the PI or MD co-investigator on a case-by-case basis, and will be admitted to the study if medication is deemed stable
研究组 & 干预措施
Immediate SMART Program Intervention
Subjects will receive the SMART-3RP intervention following study enrollment.
干预措施: SMART Program (Other)
Delayed SMART Program Intervention
Subjects will record symptoms following enrollment and receive the SMART-3RP intervention approximately 3 months following study enrollment.
干预措施: SMART Program (Other)
结局指标
主要结局
Change in anxiety symptoms as measured by the generalized anxiety disorder 7 item questionnaire (GAD-7).
时间窗: Approximately 3 months (beginning of study to completion of the program)
Change in AF-related quality of life as measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT).
时间窗: Approximately 3 months (beginning of study to completion of the program)
Change in depressive symptoms as measured by the Patient Health Questionnaire 8 item instrument (PHQ-8).
时间窗: Approximately 3 months (beginning of study to completion of the program)
次要结局
未报告次要终点
研究者
Michelle Dossett, MD, PhD, MPH
Assistant Physician
Massachusetts General Hospital