Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-04 @ 12:36 AM
Study NCT ID:
NCT03450993
Status:
COMPLETED
Last Update Posted:
2020-03-02
First Post:
2018-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMART Program for Paroxysmal Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2018-02-16', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mind-Body'], 'conditions': ['Paroxysmal Atrial Fibrillation', 'Stress']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with documented recurrent symptomatic PAF.\n* Currently on stable medical therapy for AF and willing to continue on the same treatment regimen while participating in the study.\n* No current daily practice of yoga, meditation, guided imagery or other techniques that elicit the RR.\n* Able to provide informed consent and to understand written and spoken English.\n\nExclusion Criteria:\n\n* Allergy to adhesives that prevents wearing the HRV monitor.\n* Patients unable or unwilling to participate in an intervention delivered via video conferencing.\n* End Stage renal failure or heart failure, severe unstable medical or psychiatric disease.\n* Patients deemed unable to complete protocol due to cognitive or other reasons.\n* 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'}, 'identificationModule': {'nctId': 'NCT03450993', 'briefTitle': 'SMART Program for Paroxysmal Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A SMART Approach to Reducing Atrial Fibrillation Symptoms', 'orgStudyIdInfo': {'id': '2018P000015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate SMART Program Intervention', 'description': 'Subjects will receive the SMART-3RP intervention following study enrollment.', 'interventionNames': ['Other: SMART Program']}, {'type': 'OTHER', 'label': 'Delayed SMART Program Intervention', 'description': 'Subjects will record symptoms following enrollment and receive the SMART-3RP intervention approximately 3 months following study enrollment.', 'interventionNames': ['Other: SMART Program']}], 'interventions': [{'name': 'SMART Program', 'type': 'OTHER', 'otherNames': ['Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) or Stress Management and Resiliency Training Program (SMART Program)'], '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)', 'armGroupLabels': ['Delayed SMART Program Intervention', 'Immediate SMART Program Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michelle Dossett, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Physician', 'investigatorFullName': 'Michelle Dossett, MD, PhD, MPH', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}