Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- AF Symptoms Severity and Burden questionnaire
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
3RP Intervention Group
AF Patients will undergo the 3RP intervention which will comprise of the following:
i. One-one-one session: each subject will spend an hour with a clinician to set specific goals for the intervention. They will also answer questionnaires.
ii. ECG monitoring: Enrolled subjects may be monitored with an ECG at some point after the time of consent up to the day of the one-on-one session, and again after completing the 8 weeks.
iii. Weeks 1 - 8: subjects will meet with the clinician/staff member as a group once a week for 1.5 hours each where they will be taught a variety of techniques to elicit the relaxation response as well as other cognitive skills.
At the end of the 4th (mid-point) and 8th (last) weekly session, subjects will answer questionnaires.
iv. 6 month follow up: 3 months after the final 3RP session to answer questionnaires.
v. Subjects will be asked to keep track of their AF episodes during the course of the study.
Intervention: Relaxation Response Resiliency Program (Behavioral)
3RP Waitlist Control Group
The Control Group will wait for 6 months (from the time the Intervention group starts the 3RP intervention) and then will undergo the same study procedures as the intervention group - except for the 6 month follow up.
Intervention: Relaxation Response Resiliency Program (Behavioral)
Outcomes
Primary Outcomes
AF Symptoms Severity and Burden questionnaire
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
Investigators
Jeremy n. Ruskin, MD
Director, Cardiac Arrhythmia Service
Massachusetts General Hospital