Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-19 @ 8:16 AM
Study NCT ID:
NCT06614868
Status:
RECRUITING
Last Update Posted:
2025-06-11
First Post:
2024-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minority Stress Counseling for LGBTQ+ Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2024-09-24', 'studyFirstSubmitQcDate': '2024-09-24', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': '12 weeks', 'description': 'Patient Health Questionnaire-9'}, {'measure': 'Anxiety', 'timeFrame': '12 Weeks', 'description': 'Generalized Anxiety Disorder-7'}, {'measure': 'Post Traumatic Stress', 'timeFrame': '12 Weeks', 'description': 'Patient Checklist-5'}, {'measure': 'Internalized Heterosexism', 'timeFrame': '12 Weeks', 'description': 'Internalized Homophobia Scale'}, {'measure': 'Discrimination', 'timeFrame': '12 Weeks', 'description': 'Daily Heterosexist Questionnaire'}, {'measure': 'Alcohol Problems', 'timeFrame': '16 Weeks', 'description': 'Alcohol Use Disorders Identification Test'}], 'secondaryOutcomes': [{'measure': 'Experiential Avoidance', 'timeFrame': '16 Weeks', 'description': 'Experiential Avoidance Rating Scale'}, {'measure': 'Affect', 'timeFrame': '16 Weeks', 'description': 'Positive Negative Affect Schedule'}, {'measure': 'Problematic Pornography Use', 'timeFrame': '12 Weeks', 'description': 'Brief Pornography Screen'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Minority Stress', 'Acceptance and Commitment Therapy'], 'conditions': ['Minority Stress']}, 'descriptionModule': {'briefSummary': 'Lesbian, gay, bisexual, transgender, and queer+ (LGBTQ+) individuals experience a breadth of mental health disparities. Reducing these disparities is an area of key psychological research. Minority stress is theorized to be an underlying source of the disparities (Meyer, 2003). Minority stress can be conceptualized as the internalized stigma that results from experiences of social marginalization. By reducing minority stress, it is hypothesized that generalized mental illness indicators might be reduced and indicators of wellbeing increased.', 'detailedDescription': "Adult participants will respond to advertisements by emailing a research assistant.\n\nA research assistant will then arrange for a pre-screening interview to ensure inclusion criteria are met.\n\nA research assistant will review informed consent and receive a signed informed consent during the pre-screening.\n\nParticipants who are accepted into the study will then be offered up to 12 sessions of ACT or receive an unstructured treatment as usual counseling condition delivered by graduate students in the UAB medical/clinical psychology program under the supervision of Dr. Borgogna. These sessions will be 45 minutes each and delivered in Dr. Borgogna's lab. During the first sessions a survey battery will be administered on a lab secure computer administered via Qualtrics. It will be re-administered at session six, and during the last session.\n\nThe survey will include a broad base of demographic, mental health, and minority stress measures.\n\nParticipants will be assigned a random number that will link their survey responses across sessions. Identifying information will not be gathered as part of data collection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must identify as non-heterosexual\n\nExclusion Criteria:\n\nSuicide attempt within the past 12 months.\n\nCurrent eating disorder.\n\nNarcotics use within the past 3 months\n\nNon-suicidal self-injury within the past 6 months.\n\nCurrent/History of psychosis'}, 'identificationModule': {'nctId': 'NCT06614868', 'acronym': 'MST', 'briefTitle': 'Minority Stress Counseling for LGBTQ+ Individuals', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Minority Stress Counseling for LGBTQ+ Individuals', 'orgStudyIdInfo': {'id': 'IRB-300013570'}, 'secondaryIdInfos': [{'id': 'NBLAB1', 'type': 'OTHER', 'domain': 'UAB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Participants receiving acceptance and commitment therapy', 'interventionNames': ['Behavioral: Acceptance and Commitment Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Unstructured counseling intervention', 'interventionNames': ['Behavioral: Treatment as Usual (TAU)']}], 'interventions': [{'name': 'Acceptance and Commitment Therapy', 'type': 'BEHAVIORAL', 'description': 'Up to 16 session of unstructured counseling therapy informed by Acceptance and Commitment Therapy tradition.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Treatment as Usual (TAU)', 'type': 'BEHAVIORAL', 'description': 'Unstructured counseling', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicholas Borgogna, PhD', 'role': 'CONTACT', 'email': 'borgogna@uab.edu', 'phone': '435258961'}, {'name': 'Nicholas Borgogna', 'role': 'CONTACT'}, {'name': 'Nicholas Borgogna, PhQ', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'Nicholas Borgogna (Assistant Professor), PhD', 'role': 'CONTACT', 'email': 'borgogna@uab.edu', 'phone': '7579693677'}]}, 'ipdSharingStatementModule': {'url': 'https://www.uab.edu/cas/psychology/people/faculty/nicholas-c-borgogna', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'deidentified data will be shared upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nicholas C. Borgogna', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}