Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT05746312
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2023-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "We recruited 8 Black American adults to participate in this multiple baseline study. In a multiple-baseline design, one takes repeated measurements of one's outcomes of interest across time, and subsequently compares these outcomes of interest between an initial baseline control period with no intervention and a subsequent intervention period. This is a within-subjects study design for which participants serve as their own control."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-02-23', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State anxiety', 'timeFrame': 'Duration of study visit (60-90 minutes)', 'description': 'Assessed with the State-Trait Anxiety Inventory - 6 \\[Higher Score = More Anxiety\\]'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'This study uses a multiple-baseline design and aims to replicate findings that a digital music-based mindfulness intervention can reduce elevated race-based state anxiety in Black Americans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Familiarity with meditation\n* Turns to music for emotional support\n* Elevated trait anxiety (\\>=12 on the State Trait Anxiety Inventory - Trait \\[STAIT\\]-5)\n* Majority of anxiety comes from racism or discrimination (\\>=60 on a scale of 0 \\[not at all\\] to 100 \\[entirely\\] for the following question; "If you are a racial or ethnic minority, how much do you feel that racism and/or discrimination contribute to your elevated anxiety levels?")."\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05746312', 'briefTitle': 'Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community', 'organization': {'class': 'OTHER', 'fullName': 'Harvard University'}, 'officialTitle': 'A Digital Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community: a Replication and Extension', 'orgStudyIdInfo': {'id': 'IRB21-0256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multiple-baseline study', 'description': 'All participants in this study received the same protocol. First, we had a baseline control period (no intervention) during which we assessed state anxiety levels every two minutes. Subsequently, we administered the intervention and continued to assess state anxiety at two minute intervals. Participants were randomized to baseline periods that varied in length (10,12,14, or 16 minutes of baseline).', 'interventionNames': ['Behavioral: healing attempt']}], 'interventions': [{'name': 'healing attempt', 'type': 'BEHAVIORAL', 'description': 'The intervention consists of pre-composed and pre-recorded guided meditations, songs, and poems that total 25 minutes in duration. The elements of the intervention were set to background music tracks that were informed by Black diasporic music traditions and anxiety reduction principles from the music therapy literature.', 'armGroupLabels': ['Multiple-baseline study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard University', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Grant Jones', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Grant Jones', 'investigatorAffiliation': 'Harvard University'}}}}