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Completed

NCT Number: NCT03450993

SMART Program for Paroxysmal Atrial Fibrillation

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).

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stress

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMART Program

Other

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)

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

A SMART Approach to Reducing Atrial Fibrillation Symptoms

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2018
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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