SMART Program for Paroxysmal Atrial Fibrillation

February 27, 2020 updated by: Michelle Dossett, MD, PhD, MPH, Massachusetts General Hospital

A SMART Approach to Reducing Atrial Fibrillation Symptoms

This is a pilot study to test the effects of the SMART-3RP (Stress Management and Resiliency Training Relaxation Response Resiliency Program) on quality of life, mental health, arrhythmia burden, and heart rate variability (HRV) in patients with paroxysmal atrial fibrillation (PAF).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mind-body practices that elicit the relaxation response (RR) have been used worldwide to prevent and treat disease. The Stress Management and Resiliency Training - Relaxation Response Resiliency Program (SMART-3RP) is an 8-week manualized psycho-educational program that incorporates RR methods such as meditation or seated yoga along with cognitive skills building and lifestyle approaches to increase resiliency to stress. This study will use a randomized, wait-list controlled trial design to test the effects of the SMART-3RP on quality of life (QoL), mental health, arrhythmia burden, and HRV in patients with PAF. The program will be delivered virtually (via computer video conferencing), questionnaires will be completed, and physiological data as well as blood will be collected.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Diagnosed with documented recurrent symptomatic PAF.
  • Currently on stable medical therapy for AF and willing to continue on the same treatment regimen while participating in the study.
  • No current daily practice of yoga, meditation, guided imagery or other techniques that elicit the RR.
  • Able to provide informed consent and to understand written and spoken English.

Exclusion Criteria:

  • Allergy to adhesives that prevents wearing the HRV monitor.
  • Patients unable or unwilling to participate in an intervention delivered via video conferencing.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate SMART Program Intervention
Subjects will receive the SMART-3RP intervention following study enrollment.
Other: SMART Program
This is an 8-week, multimodal resiliency program that targets stress with 4 main components: mind-body skills (participants learn a variety of meditation techniques, mini relaxations, walking meditation, and yoga), traditional stress management techniques, healthy lifestyle behaviors (sleep, exercise, nutrition, and social support), and cognitive reappraisal and adaptive coping skills (borrowed from cognitive behavioral therapy, acceptance and commitment therapy, and positive psychology)
Other Names:
  • Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) or Stress Management and Resiliency Training Program (SMART Program)
Other: Delayed SMART Program Intervention
Subjects will record symptoms following enrollment and receive the SMART-3RP intervention approximately 3 months following study enrollment.
Other: SMART Program
This is an 8-week, multimodal resiliency program that targets stress with 4 main components: mind-body skills (participants learn a variety of meditation techniques, mini relaxations, walking meditation, and yoga), traditional stress management techniques, healthy lifestyle behaviors (sleep, exercise, nutrition, and social support), and cognitive reappraisal and adaptive coping skills (borrowed from cognitive behavioral therapy, acceptance and commitment therapy, and positive psychology)
Other Names:
  • Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) or Stress Management and Resiliency Training Program (SMART Program)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in anxiety symptoms as measured by the generalized anxiety disorder 7 item questionnaire (GAD-7).
Time Frame: Approximately 3 months (beginning of study to completion of the program)
Approximately 3 months (beginning of study to completion of the program)
Change in AF-related quality of life as measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT).
Time Frame: Approximately 3 months (beginning of study to completion of the program)
Approximately 3 months (beginning of study to completion of the program)
Change in depressive symptoms as measured by the Patient Health Questionnaire 8 item instrument (PHQ-8).
Time Frame: Approximately 3 months (beginning of study to completion of the program)
Approximately 3 months (beginning of study to completion of the program)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Michelle Dossett, MD, PHD, MPH, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2018

Primary Completion (Actual)

January 4, 2019

Study Completion (Actual)

January 4, 2019

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

February 23, 2018

First Posted (Actual)

March 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018P000015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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