Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-01 @ 2:36 PM
Study NCT ID:
NCT07143357
Status:
RECRUITING
Last Update Posted:
2025-10-23
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mind-body Resilience Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Recruitment', 'timeFrame': 'pre-test', 'description': 'Proportion of eligible dyads that consent to participation'}, {'measure': 'Feasibility of Randomization', 'timeFrame': 'The end of treatment at 6 weeks', 'description': 'Proportion of randomized participants who submit post-test assessments'}, {'measure': 'Feasibility of Assessment Completion', 'timeFrame': 'pre-test, the end of treatment at 6 weeks, and 3 months after the end of treatment', 'description': 'Proportion of participants with no assessment measures missing at pre-test, post-test, and 3 month follow-up'}, {'measure': 'Feasibility of Program Adherence (RT-CA 1)', 'timeFrame': 'the end of treatment at 6 weeks', 'description': 'Proportion of RT-CA 1 dyads that initiate the program by attending session 1 and complete at least 4 of 6 sessions.'}, {'measure': 'Therapist Fidelity', 'timeFrame': 'the end of treatment at 6 weeks', 'description': 'Proportion of 20% randomly-selected RT-CA 1 sessions in which the therapist fully adheres to program content, ascertained by a fidelity checklist'}, {'measure': 'Treatment Satisfaction (RT-CA 1)', 'timeFrame': 'the end of treatment at 6 weeks', 'description': 'Proportion of RT-CA 1 participants that endorse satisfaction, defined as above the midpoint on the Client Satisfaction Questionnaire-3'}, {'measure': 'Credibility (RT-CA 1)', 'timeFrame': 'pre-test', 'description': 'Proportion of RT-CA 1 participants that endorse program credibility at pre-test, defined as scoring above the midpoint on the Credibility sub scale of the Credibility/Expectancy Questionnaire'}, {'measure': 'Expectancy (RT-CA 1)', 'timeFrame': 'pre-test', 'description': 'Proportion of RT-CA 1 participants that endorse expectancy to improve. from the program at pre-test, defined as scoring above the midpoint on the Expectancy sub scale of the Credibility/Expectancy Questionnaire'}, {'measure': 'Study safety', 'timeFrame': 'at the end of treatment at 6 weeks and 3 months after the end of treatment', 'description': 'The proportion of participants that report no adverse events related to study participation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['emotional distress', 'cardiac arrest', 'cardiac arrest survivorship', 'caregivers', 'resilience', 'mindfulness', 'mind-body', 'behavioral interventions', 'anxiety', 'depression'], 'conditions': ['Emotional Distress', 'Cardiac Arrest (CA)', 'Anxiety', 'Depression', 'Caregivers', 'Survivorship', 'Resilience', 'Mindfulness']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.', 'detailedDescription': 'The goal of this study is to test the feasibility of our proposed interventions through a pilot RCT. The investigators will deliver the RCT intervention (N=42 dyads; 84 participants total) and evaluate feasibility and acceptability based on a priori benchmarks.\n\nThe RCT will initially take place at Massachusetts General Hospital intensive care units and step-down units. Cardiac arrest survivor-caregiver dyads will be randomly assigned to one of two groups - Recovering Together after Cardiac Arrest 1 (RT-CA 1) or Recovering Together after Cardiac Arrest 2 (RT-CA 2).\n\nRT-CA 1 involves six, 30-minute weekly sessions beginning at bedside and continuing over Zoom after the survivor is discharged. RT-CA 2 involves one, 30 minute session at bedside.\n\nAll participants will complete psychosocial survey measures at baseline, six weeks, and 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Out-of-hospital or in-hospital CA survivor (must have new diagnosis of "cardiac arrest" in electronic medical record from index hospitalization with documented loss of pulse) with an identified caregiver (identified by the survivor who is their primary source of emotional and functional support)\n2. survivor must score \\>5 on Short Form of the Mini Mental State Exam for sufficient cognitive function for meaningful participation\n3. ability and willingness to participate in a hybrid in-person/live video intervention\n4. English speaking adults (18 year or older)\n5. at least one member of the dyad endorses clinically significant emotional distress during screening (\\>7 on either of the Hospital Anxiety and Depression Scale subscales).\n\nExclusion Criteria:\n\n1. active psychosis, mania, substance dependence, or suicidal intent or plan that would require a higher level of care\n2. any other psychiatric or neurological condition that would preclude meaningful participation\n3. the caregiver must not be a cardiac arrest survivor'}, 'identificationModule': {'nctId': 'NCT07143357', 'acronym': 'RT-CA', 'briefTitle': 'Mind-body Resilience Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Development of a Dyadic Mind-body Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest (RT-CA).', 'orgStudyIdInfo': {'id': '2025P002063'}, 'secondaryIdInfos': [{'id': '5K23AT012487', 'link': 'https://reporter.nih.gov/quickSearch/5K23AT012487', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recovering Together after Cardiac Arrest 1', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.', 'interventionNames': ['Behavioral: Recovering Together after Cardiac Arrest 1']}, {'type': 'OTHER', 'label': 'Recovering Together after Cardiac Arrest 2', 'description': 'Recovering Together after Cardiac Arrest is a minimally enhanced usual care control. Dyads will participate in one 30-minute session with a clinician reviewing available psychosocial resources for cardiac arrest survivors and their caregivers.', 'interventionNames': ['Other: Recovering Together after Cardiac Arrest 2']}], 'interventions': [{'name': 'Recovering Together after Cardiac Arrest 1', 'type': 'BEHAVIORAL', 'description': 'The intervention will teach resiliency skills (mindfulness and coping) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person until the survivor is discharged; remaining sessions will occur over Zoom.', 'armGroupLabels': ['Recovering Together after Cardiac Arrest 1']}, {'name': 'Recovering Together after Cardiac Arrest 2', 'type': 'OTHER', 'description': 'In this minimally enhanced usual care control, dyads will participate in one 30-minute session with a clinician at beside to review a pamphlet of available psychosocial resources for cardiac arrest survivors and their caregivers.', 'armGroupLabels': ['Recovering Together after Cardiac Arrest 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander Presciutti, PhD', 'role': 'CONTACT', 'email': 'apresciutti@mgh.harvard.edu', 'phone': '617-726-7913'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Alexander Presciutti, PhD', 'role': 'CONTACT', 'email': 'apresciutti@mgh.harvard.edu', 'phone': '617-726-7913'}, {'name': 'Sara Bogan, BA', 'role': 'CONTACT', 'email': 'sbogan@mgh.harvard.edu', 'phone': '617-724-1312'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'IPD will be available from trial end through three years after the publication of all study results.', 'ipdSharing': 'YES', 'description': 'De-identified data will be shared upon reasonable request.', 'accessCriteria': 'Individuals will be able to access the data after signing a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Member of the Faculty', 'investigatorFullName': 'Alexander Presciutti', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}