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

NCT ID: NCT02634697

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-01-09

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.

Conditions

Atrial Fibrillation; Stress; Quality of Life; Anxiety; Depression; Hostility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Relaxation Response Resiliency Program

Intervention Type: BEHAVIORAL

8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga

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.

Group Type: ACTIVE_COMPARATOR

Relaxation Response Resiliency Program

Intervention Type: BEHAVIORAL

8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga

Interventions

Relaxation Response Resiliency Program

8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga

Intervention Type: BEHAVIORAL

Other Intervention Names

3RP

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benson-Henry Institute for Mind Body Medicine

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeremy n. Ruskin, MD

Director, Cardiac Arrhythmia Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeremy N Ruskin, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2015P000552

Identifier Type: -

Identifier Source: org_study_id