NCT03450993

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

February 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2019

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

February 16, 2018

Last Update Submit

February 27, 2020

Conditions

Paroxysmal Atrial FibrillationStress

Keywords

Mind-Body

Outcome Measures

Primary Outcomes (3)

  • Change in anxiety symptoms as measured by the generalized anxiety disorder 7 item questionnaire (GAD-7).

    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).

    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).

    Approximately 3 months (beginning of study to completion of the program)

Study Arms (2)

Immediate SMART Program Intervention

EXPERIMENTAL

Subjects will receive the SMART-3RP intervention following study enrollment.

Other: SMART Program

Delayed SMART Program Intervention

OTHER

Subjects will record symptoms following enrollment and receive the SMART-3RP intervention approximately 3 months following study enrollment.

Other: SMART Program

Interventions

SMART ProgramOTHER

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)

Also known as: Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) or Stress Management and Resiliency Training Program (SMART Program)
Delayed SMART Program InterventionImmediate SMART Program Intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michelle Dossett, MD, PhD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Physician

Study Record Dates

First Submitted

February 16, 2018

First Posted

March 1, 2018

Study Start

February 23, 2018

Primary Completion

January 4, 2019

Study Completion

January 4, 2019

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations

US(1)