SMART Program for Paroxysmal Atrial Fibrillation

Mass General Brigham

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation; Stress

Treatments: Other: SMART Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03450993

2018P000015

Details and patient eligibility

About

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).

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Immediate SMART Program Intervention

Experimental group

Description:

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

Treatment:

Other: SMART Program

Delayed SMART Program Intervention

Other group

Description:

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

Treatment:

Other: SMART Program