Clinical trial NCT03450993: SMART Program for Paroxysmal Atrial Fibrillation
Official title: A SMART Approach to Reducing Atrial Fibrillation Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Stress
Keywords: Mind-Body
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in anxiety symptoms as measured by the generalized anxiety disorder 7 item questionnaire (GAD-7).
timeFrame: Approximately 3 months (beginning of study to completion of the program)
measure: Change in AF-related quality of life as measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT).
timeFrame: Approximately 3 months (beginning of study to completion of the program)
measure: Change in depressive symptoms as measured by the Patient Health Questionnaire 8 item instrument (PHQ-8).
timeFrame: Approximately 3 months (beginning of study to completion of the program)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Michelle Dossett, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: