Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- AF Symptoms Severity and Burden questionnaire
研究概览
简要总结
The purpose of this study is to determine if an eight week multimodal Relaxation Response Resiliency Program (3RP) intervention can effectively improve symptom severity, frequency and quality of life (Q.O.L) in atrial fibrillation (AF) patients. This will be measured by a reduction in AF symptom score, perceived stress, anxiety, hostility and depression.
详细描述
Atrial fibrillation (AF) is a very common cardiovascular disease. Symptoms include dizziness, palpitations, lightheadedness, shortness of breath, fatigue and exercise intolerance. AF is also associated with a high risk of complications like thrombo-embolism and stroke, heart failure, dementia. The presence and severity of these symptoms and complications adversely affect a patient's health related quality of life. Improvement in quality of life (QOL) is an important measure for evaluating response to treatment in AF patients. Depression and anxiety are significant part of the psychosocial burden faced by approximately one-third of AF patients, and are important components that effect QOL in these patients. In this study the investigators will apply the 3RP (Relaxation Response Resiliency Program - developed at the Benson Henry Institute at Massachusetts General Hospital) intervention among AF patients to assess the reduction in their stress, anxiety and depression levels and the reduction in AF symptom burden and severity.
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
- None
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
- •Age: 18-90 years
- •Diagnosed with documented recurrent symptomatic paroxysmal atrial fibrillation
- •Currently on stable medical therapy for AF and willing to continue on the same treatment regimen for 8 weeks while participating in the study.
- •No current or prior practice of yoga, meditation, guided imagery or other techniques that elicit relaxation response (RR).
- •Able to provide informed consent and to understand written and spoken English.
排除标准
- •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
结局指标
主要结局
AF Symptoms Severity and Burden questionnaire
时间窗: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
A 19-item measure assessing the severity, burden, and impact of one's atrial fibrillation symptoms.
Measure of Current Status (MOCS-A)
时间窗: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
The MOCS-A is a 13-item measure assessing participants' current self-perceived status on several skills such as: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
次要结局
- Medical Outcomes Study (MOS) Social Support Survey(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- FACIT-Spirituality(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Lifestyle Questionnaire(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- RR Adherence Questionnaire(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- General Self-Efficacy Scale(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Visual Analog Stress Scale(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Cognitive and Affective Mindfulness Scale (CAMS)(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Buss-Perry Hostility Scale(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- The Gratitude Questionnaire (GQ-6)(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Cigna Healthy Eating Scale(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Interpersonal Reactivity Index (IRI)(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Life Orientation Test (LOT) Optimism Scale(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Pittsburgh Sleep Quality Index (PSQI)(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Fatigue and Distress Analogue Scale(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Medication Use Questionnaire(Change between Baseline (week 0), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Generalized Anxiety Disorder 7-item (GAD-7)(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Positive and Negative Affect Schedule (PANAS)(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Patient Health Questionnaire (PHQ)(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Penn State Worry Questionnaire (PSWQ)(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Perceived Stress Scale (PSS-10)(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
- Smoking Questionnaire(Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26))
研究者
Jeremy n. Ruskin, MD
Director, Cardiac Arrhythmia Service
Massachusetts General Hospital