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SMART Program for Paroxysmal Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT03450993
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Michelle Dossett, MD, PhD, MPH, Massachusetts General Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Stress Other: SMART Program Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A SMART Approach to Reducing Atrial Fibrillation Symptoms
Actual Study Start Date : February 23, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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 Name: Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) or Stress Management and Resiliency Training Program (SMART Program)

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 Name: Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) or Stress Management and Resiliency Training Program (SMART Program)




Primary Outcome Measures :
  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) ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450993


Contacts
Contact: Gillian Gadenne 617-643-6062 ggadenne@mgh.harvard.edu
Contact: Michelle Dossett, MD, PhD, MPH 617-643-6034 mdossett@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Gillian Gadenne    617-643-6062    ggadenne@mgh.harvard.edu   
Contact: Michelle Dossett, MD, PHD, MPH    617-643-6034    mdossett@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Michelle Dossett, MD, PhD, MPH Massachusetts General Hospital

Responsible Party: Michelle Dossett, MD, PhD, MPH, Assistant Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03450993     History of Changes
Other Study ID Numbers: 2018P000015
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michelle Dossett, MD, PhD, MPH, Massachusetts General Hospital:
Mind-Body

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes