Clinical trial NCT02634697: Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation
Official title: Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Stress
Quality of Life
Anxiety
Depression
Hostility
Keywords: Atrial Fibrillation
Relaxation Response Resiliency Program Intervention
AF Symptom Severity and Burden
Stress, Anxiety, Depression and Hostility
Quality of Life
AF
QOL
3RP
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Benson-Henry Institute for Mind Body Medicine
First posted: 2015-12-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Age: 18-90 years
2. Diagnosed with documented recurrent symptomatic paroxysmal atrial fibrillation
3. Currently on stable medical therapy for AF and willing to continue on the same treatment regimen for 8 weeks while participating in the study.
4. No current or prior practice of yoga, meditation, guided imagery or other techniques that elicit relaxation response (RR).
5. Able to provide informed consent and to understand written and spoken English.

Exclusion Criteria:

1. End Stage renal failure or heart failure, severe unstable medical or psychiatric disease
2. Patients deemed unable to complete protocol due to cognitive or other reasons.
3. 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

Primary outcomes:
measure: AF Symptoms Severity and Burden questionnaire
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Measure of Current Status (MOCS-A)
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary outcomes:
measure: Visual Analog Stress Scale
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Buss-Perry Hostility Scale
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Cognitive and Affective Mindfulness Scale (CAMS)
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Cigna Healthy Eating Scale
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: FACIT-Spirituality
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: The Gratitude Questionnaire (GQ-6)
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Interpersonal Reactivity Index (IRI)
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Life Orientation Test (LOT) Optimism Scale
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Medical Outcomes Study (MOS) Social Support Survey
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Patient Health Questionnaire (PHQ)
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Lifestyle Questionnaire
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Perceived Stress Scale (PSS-10)
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: RR Adherence Questionnaire
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: General Self-Efficacy Scale
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Fatigue and Distress Analogue Scale
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Smoking Questionnaire
timeFrame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
measure: Medication Use Questionnaire
timeFrame: Change between Baseline (week 0), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Other outcomes:
measure: Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients with AF
timeFrame: Baseline (week 0)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeremy N Ruskin, MD
role: PRINCIPAL_INVESTIGATOR
References: