Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation

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.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Stress; Atrial Fibrillation; Anxiety; Hostility
• Intervention / Treatment: Behavioral: Relaxation Response Resiliency Program

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Relaxation Response Resiliency Program; 8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga; Other Names: 3RP
Active Comparator: 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.	Behavioral: Relaxation Response Resiliency Program; 8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga; Other Names: 3RP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF Symptoms Severity and Burden questionnaire	A 19-item measure assessing the severity, burden, and impact of one's atrial fibrillation symptoms.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Measure of Current Status (MOCS-A)	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.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Stress Scale	Measures one's distress, stress, and ability to cope with that stress over the past week on a scale from 0 to 10.	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	A 29-item questionnaire that measures a one's levels of aggression.	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)	Measures the degree to which individuals experience their thoughts and feelings.	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	A 7-item self-report instrument that measures behavioral eating.	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	Measures spiritual well-being (sense of meaning in life and the sense of strength in one's faith).	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Generalized Anxiety Disorder 7-item (GAD-7)	A brief measure for assessing generalized anxiety disorder	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)	The GQ-6 revised is a 6-item measure that assesses individual differences in the proneness to experience gratitude in daily life. Scores range from 6-42, with a higher score indicating a greater sense of gratitude.	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)	The IRI assesses the cognitive and affective dimensions of empathy.	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	The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.	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	The MOS Social Support Survey measures various dimensions of social support.	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)	The PANAS comprises two mood scales, one that measures positive affect and the other which measures negative affect.	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)	The PHQ measures symptoms of depression and functional impairment.	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	Measures physical activity and health behaviors.	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)	Assesses sleep quality and discriminates between good and poor sleepers.	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)	The PSS is a widely used psychological instrument for the measurement of the perception of stress. This 10-itam scale is designed to measure the degree to which situations in one's life are appraised, or considered stressful. The scores range from 0-40, with a higher score indicating higher perceived stress. Items were designed to detect how unpredictable, uncontrollable and overloaded respondents find their lives.	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)	Measures the trait (or tendency towards) worry in individuals.	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	Assesses the number of days a week where participants practiced RR skills.	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	Measures optimistic self-beliefs to cope with a variety of difficult demands in life.	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	Measures one's distress and fatigue over the past week on a scale from 0 to 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	Measures the prevalence and frequency of an individual's smoking habits.	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	Patients list their medication name, dosage, and frequency.	Change between Baseline (week 0), post-intervention (week 9), and 3-month follow up (week 13 or week 26)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients with AF	This questionnaire asks AF patients to report their age, gender, race, ethnicity, marital status, highest level of education, and current employment status.	Baseline (week 0)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Benson-Henry Institute for Mind Body Medicine
• Investigators: Principal Investigator: Jeremy N Ruskin, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): January 9, 2017
• Study Completion (Actual): January 9, 2017

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 18, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Quality of Life; QOL; AF; 3RP; Relaxation Response Resiliency Program Intervention; AF Symptom Severity and Burden; Stress, Anxiety, Depression and Hostility
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Depression; Atrial Fibrillation
• Other Study ID Numbers: 2015P000552