Paroxysmal Atrial FibrillationNCT03450993
SMART Program for Paroxysmal Atrial Fibrillation
A study testing SMART Program in people with Paroxysmal Atrial Fibrillation and Stress, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Stress
- What is being tested?
- SMART Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2018to 4 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A SMART Approach to Reducing Atrial Fibrillation Symptoms
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).
Read the 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.
- Conditions
- Paroxysmal Atrial Fibrillation, Stress
- Being tested
- SMART Program
- Keywords
- Mind-Body
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART ProgramOther
Also called Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) or Stress Management and Resiliency Training Program (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)
| Study group | Role | What they receive |
|---|---|---|
| Immediate SMART Program Intervention | Experimental | Subjects will receive the SMART-3RP intervention following study enrollment. Receives: 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. Receives: Other: SMART Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety symptoms as measured by the generalized anxiety disorder 7 item questionnaire (GAD-7).
Measured: 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).
Measured: 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).
Measured: Approximately 3 months (beginning of study to completion of the program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start23 Feb 2018
- Primary completion4 Jan 2019
- Study completion4 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Dossett, MD, PhD, MPH, Massachusetts General Hospital
- Investigators
- Michelle Dossett, MD, PhD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450993
- Sponsor's protocol ID
- 2018P000015
- Status last verified
- Feb 2020
- First submitted
- 16 Feb 2018
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SMART Approach to Reducing Atrial Fibrillation Symptoms
- ClinicalTrials.gov ID
- NCT03450993
- Acronym / sponsor ID
- 2018P000015
- Conditions
- Paroxysmal Atrial Fibrillation, Stress
- Keywords
- Mind-Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 4 Jan 2019 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate SMART Program Intervention | Experimental | Other: SMART ProgramSubjects will receive the SMART-3RP intervention following study enrollment. |
| Delayed SMART Program Intervention | Other | Other: SMART ProgramSubjects will record symptoms following enrollment and receive the SMART-3RP intervention approximately 3 months following study enrollment. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART ProgramAlso: Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) or Stress Management and Resiliency Training Program (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 | Delayed SMART Program Intervention, Immediate SMART Program Intervention |
Primary outcome
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Dossett, MD, PhD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART Program in people with Paroxysmal Atrial Fibrillation and Stress, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.