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

NCT02634697 | Completed

• 1 other identifier: 2015P000552
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (21)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (1)

• Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients with AF

  Baseline (week 0)

Study Arms (2)

3RP Intervention Group

EXPERIMENTAL

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

3RP Waitlist Control Group

ACTIVE COMPARATOR

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

Interventions

Relaxation Response Resiliency Program BEHAVIORAL

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

Also known as: 3RP

3RP Intervention Group; 3RP Waitlist Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Benson-Henry Institute for Mind Body Medicine: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jeremy N Ruskin, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Arrhythmia Service

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 18, 2015
• Study Start: April 1, 2015
• Primary Completion: January 9, 2017
• Study Completion: January 9, 2017
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

US (1)