Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT04193605
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2019-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cclamber@uab.edu', 'phone': '205-934-3481', 'title': 'Crystal Chapman Lambert', 'organization': 'School of Nursing at the University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This is a feasibility. Therefore, we were not powered to detect changes in specific outcome measures. The primary outcome was feasibility.'}}, 'adverseEventsModule': {'timeFrame': 'The intervention was eight weeks long. Therefore, adverse events were collected for 8 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Mindfulness Based Stress Reduction', 'description': 'MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.\n\nMindfulness: The traditional MBSR intervention consists of the following: (1) a series of eight weekly session of 2.5 to 3 hours; (2) a silent retreat during the sixth week; (3) daily home assignments including formal and informal mindfulness practices; and (4) didactic presentations on stress and the consequences of stress. We are culturally tailoring the intervention with the goal of maintain fidelity.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'The control condition will continue receiving usual care or standard of care.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility Intervention Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Based Stress Reduction', 'description': 'MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.\n\nMindfulness: The traditional MBSR intervention consists of the following: (1) a series of eight weekly session of 2.5 to 3 hours; (2) a silent retreat during the sixth week; (3) daily home assignments including formal and informal mindfulness practices; and (4) didactic presentations on stress and the consequences of stress. We are culturally tailoring the intervention with the goal of maintain fidelity.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'The control condition will continue receiving usual care or standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the intervention(which consists of an orientation followed by eight weekly sessions, consistent with MSBR interventions), the measure was collected within one week of completing the final session.', 'description': 'Feasibility was measured using a four-item feasibility of intervention measure. Each item is scored using a Likert-like scale ranging from "1" completely disagree to "5" completely agree. Higher scores indicate greater feasibility. The minimum total score is 4 points, and the maximum total score is 20.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the standard of care did not receive the intervention. Therefore, data was not collected or analyzed on these participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mindfulness Based Stress Reduction', 'description': 'MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.\n\nMindfulness: The traditional MBSR intervention consists of the following: (1) a series of eight weekly session of 2.5 to 3 hours; (2) a silent retreat during the sixth week; (3) daily home assignments including formal and informal mindfulness practices; and (4) didactic presentations on stress and the consequences of stress. We are culturally tailoring the intervention with the goal of maintain fidelity.'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'The control condition will continue receiving usual care or standard of care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mindfulness Based Stress Reduction', 'description': 'MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.\n\nMindfulness: The traditional MBSR intervention consists of the following: (1) a series of eight weekly session of 2.5 to 3 hours; (2) a silent retreat during the sixth week; (3) daily home assignments including formal and informal mindfulness practices; and (4) didactic presentations on stress and the consequences of stress. We are culturally tailoring the intervention with the goal of maintain fidelity.'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'The control condition will continue receiving usual care or standard of care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '47.4', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '47.1', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-31', 'size': 135710, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-24T15:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2019-12-05', 'resultsFirstSubmitDate': '2023-12-30', 'studyFirstSubmitQcDate': '2019-12-06', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-24', 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility Intervention Measure', 'timeFrame': 'Immediately after the intervention(which consists of an orientation followed by eight weekly sessions, consistent with MSBR interventions), the measure was collected within one week of completing the final session.', 'description': 'Feasibility was measured using a four-item feasibility of intervention measure. Each item is scored using a Likert-like scale ranging from "1" completely disagree to "5" completely agree. Higher scores indicate greater feasibility. The minimum total score is 4 points, and the maximum total score is 20.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections', 'Health Behavior']}, 'descriptionModule': {'briefSummary': 'The investigator propose to culturally adapt the mindfulness-based stress reduction (MSBR) intervention for Black/African American women living with HIV (WLWH) to reduce stress and enhance HIV self-care behaviors and viral load (VL) suppression, which has the potential to attenuate prominent racial and gender disparities experienced by Black WLWH in the US. Specifically, the investigator aims to 1) culturally adapt the MBSR intervention for Black WLWH using ADAPT-ITT; 2) pre-pilot the adapted intervention via an open non-randomized pilot study to further refine the culturally adapted intervention; and 3) conduct a 2-armed randomized pilot test of the behavioral intervention compared to standard of care to assess the feasibility and acceptability the adapted MBSR intervention for Black WLWH. The investigator hypothesis that the adapted intervention will be feasible and acceptable to member of the target population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participants are required to be born a female.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cisgender females\n* HIV seropositive\n* 18 years of age or older\n* English speaking\n* An active patient at the local HIV ambulatory clinic in Alabama.\n\nExclusion Criteria:\n\n* Non-English speaking\n* Appear temporarily impaired (e.g., intoxicated)\n* Not willing to or legally unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT04193605', 'briefTitle': 'Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV', 'orgStudyIdInfo': {'id': 'K23AT010567', 'link': 'https://reporter.nih.gov/quickSearch/K23AT010567', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K23AT010567', 'link': 'https://reporter.nih.gov/quickSearch/K23AT010567', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness Based Stress Reduction', 'description': 'MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.', 'interventionNames': ['Behavioral: Mindfulness']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'The control condition will continue receiving usual care or standard of care.'}], 'interventions': [{'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'description': 'The traditional MBSR intervention consists of the following: (1) a series of eight weekly session of 2.5 to 3 hours; (2) a silent retreat during the sixth week; (3) daily home assignments including formal and informal mindfulness practices; and (4) didactic presentations on stress and the consequences of stress. We are culturally tailoring the intervention with the goal of maintain fidelity.', 'armGroupLabels': ['Mindfulness Based Stress Reduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB School of Nursing', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'UAB maintains the following universal data sharing policy for all investigators:\n\n1. Data will be made available, in accordance with the NIH Data Sharing Policy (http://grants.nih.gov/grants/policy/data\\_sharing) to all researchers in both the private and public sector free or for a nominal charge and with minimal restriction. In some cases the institution may determine that the public and the research community are better served by a licensing program whether or not patents have been filed. This may be relevant, for example, if a tool is best distributed under license to guarantee reagent availability and quality.\n2. As a means of sharing knowledge, NIH encourages grantees to arrange for publication of NIH-supported original research in primary scientific journals. We therefore will strive to publish our findings in a timely manner and acknowledge that the research was supported by the NIH.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Crystal C. Lambert', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}