Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2026-01-16 @ 3:58 AM
Study NCT ID:
NCT06544902
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-13
First Post:
2024-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women - Realist Women Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000091702', 'term': 'Intersectional Framework'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2024-08-05', 'studyFirstSubmitQcDate': '2024-08-05', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in stress as measured by Perceived Stress Scale (PSS)', 'timeFrame': 'Baseline and up to 6 months', 'description': 'scores ranging from 0 (no symptoms) to 40 (highest severity).'}, {'measure': 'Change in discrimination as measured by Intersectional Discrimination Index (InDI)', 'timeFrame': 'Baseline and up to 6 months', 'description': 'scores ranging from 0 to 4; higher scores indicate greater anticipated intersectional discrimination.'}, {'measure': 'Change in Traumatic stress as measured by Life Events Checklist', 'timeFrame': 'Baseline and up to 6 months', 'description': 'This self-report checklist screens for potentially traumatic events in an individual\'s lifetime. Scores range from 1 to 17, higher scores indicate higher traumatic exposures. It consists of 17 questions with responses such as "happened to me," "witnessed it," "learned about it," "part of my job," "not sure," and "doesn\'t apply."'}, {'measure': 'Change in stress as measured by the chronic stress scale', 'timeFrame': 'Baseline and up to 6 months', 'description': 'The Chronic Stress Scale is a 51-item scale that evaluates the perceived experience of chronic stress. Scores range from 0 (not true) to 2 (very true).'}, {'measure': 'Change in stress as measured by the Stress in Context (SIC) Questionnaire', 'timeFrame': 'Baseline and up to 6 months', 'description': 'The SIC Questionnaire is a 21-item survey assessing stress perception in specific contexts (e.g., home, work, social relationships), with scoring from 1 (never) to 4 (usually).'}, {'measure': 'Change in stress as measured by the Giscombe Superwoman Schema Questionnaire', 'timeFrame': 'Baseline and up to 6 months', 'description': 'It contains 35 statements rated from 0 (not true) to 4 (true all the time) across the 5 subscales. subscale items are summed to create one Super Woman Schema (SWS) total, these categories can be used: 0-35: Low SWS 36-70: Moderate SWS 71-105: High SWS'}], 'secondaryOutcomes': [{'measure': 'Change in resiliency as measured by Connor-Davidson Resilience Scale (CD-RISC)', 'timeFrame': 'Baseline and up to 6 months', 'description': 'Scores range from 0-40 higher scores indicate higher resiliency'}, {'measure': 'Change in objective sleep health as measured by Sleep Health Objective', 'timeFrame': 'Baseline and up to 6 months', 'description': 'Sleep will be assessed using actigraphy measured in hours.'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Baseline and up to 3 months after intervention', 'description': 'Measured by millimeter of mercury'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intersectional Framework'], 'conditions': ['Stress', 'Hypertension']}, 'descriptionModule': {'briefSummary': "The Realist Women Study wants to see if a special program using virtual reality can help Black women deal with stress and improve Black women's heart health. The study team wants to see if using virtual reality (VR) can help with stress of Black women. The investigator will look at things like sleep, stress, and how well the VR works. The investigator also wants to know about any problems Black women might have using virtual reality."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self-identified as a Black woman\n* at least 21 years of age\n* fluency in English\n* International Classification of Diseases (ICD)10 diagnosis of hypertension\n* being a South Florida resident\n* willing to be audio-recorded\n\nExclusion Criteria:\n\n* History of psychosis disorders\n* absence of vision and cognitive impairment\n* absence of epilepsy disorders\n* absence of motion sickness.'}, 'identificationModule': {'nctId': 'NCT06544902', 'briefTitle': 'Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women - Realist Women Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women', 'orgStudyIdInfo': {'id': '20240402'}, 'secondaryIdInfos': [{'id': '1K01HL175286-01', 'link': 'https://reporter.nih.gov/quickSearch/1K01HL175286-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR-Stress Management Group', 'description': 'Participants in this group will receive VR intervention for up to 6 months', 'interventionNames': ['Other: VR Stress Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education Control Group', 'description': 'Participants in this group will be exposed to standard care through educational materials for up to 6 months.', 'interventionNames': ['Behavioral: Education Control']}], 'interventions': [{'name': 'VR Stress Management', 'type': 'OTHER', 'description': 'First Resort (FR) is an eight-week wellness program that comprises 22 modules, each lasting between 10 and 20 minutes, participants will complete modules weekly in person. Each module will teach participants about values-based goal setting/ behavioral activation, and cognitive restructuring.', 'armGroupLabels': ['VR-Stress Management Group']}, {'name': 'Education Control', 'type': 'BEHAVIORAL', 'description': "Participants in this group will receive one-time educational material regarding stress. The participants can review the material remotely. American Heart Association (AHA) brochures and infographics regarding chronic stress and women's health, heart disease and mental health among black women, healthy for good sleep well, among other useful resources.", 'armGroupLabels': ['Education Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Judite Blanc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Judite Blanc', 'investigatorAffiliation': 'University of Miami'}}}}