Back to resultsSMART Program for Paroxysmal Atrial Fibrillation
Primary Purpose
Paroxysmal Atrial Fibrillation, Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMART Program
Sponsored by
About this trial
This is an interventional supportive care trial for Paroxysmal Atrial Fibrillation focused on measuring Mind-Body
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Immediate SMART Program Intervention
Delayed SMART Program Intervention
Arm Description
Subjects will receive the SMART-3RP intervention following study enrollment.
Subjects will record symptoms following enrollment and receive the SMART-3RP intervention approximately 3 months following study enrollment.
Outcomes
Primary Outcome Measures
Change in anxiety symptoms as measured by the generalized anxiety disorder 7 item questionnaire (GAD-7).
Change in AF-related quality of life as measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT).
Change in depressive symptoms as measured by the Patient Health Questionnaire 8 item instrument (PHQ-8).
Secondary Outcome Measures
Full Information
NCT ID
NCT03450993
First Posted
February 16, 2018
Last Updated
February 27, 2020
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03450993
Brief Title
SMART Program for Paroxysmal Atrial Fibrillation
Official Title
A SMART Approach to Reducing Atrial Fibrillation Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
January 4, 2019 (Actual)
Study Completion Date
January 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Stress
Keywords
Mind-Body
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate SMART Program Intervention
Arm Type
Experimental
Arm Description
Subjects will receive the SMART-3RP intervention following study enrollment.
Arm Title
Delayed SMART Program Intervention
Arm Type
Other
Arm Description
Subjects will record symptoms following enrollment and receive the SMART-3RP intervention approximately 3 months following study enrollment.
Intervention Type
Other
Intervention Name(s)
SMART Program
Other Intervention Name(s)
Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) or Stress Management and Resiliency Training Program (SMART Program)
Intervention Description
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)
Primary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Dossett, MD, PhD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
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SMART Program for Paroxysmal Atrial Fibrillation
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