Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05599620
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2022-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2022-10-25', 'studyFirstSubmitQcDate': '2022-10-28', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol Use', 'timeFrame': 'Change from baseline alcohol use at 6 months.', 'description': 'The number of past month drinking days (Minmum = 0, Maximum = 30), average drinks per drinking day (Minmum = 0, Maximum = unspecificed), number of heavy drinking days (Minimum = 0, Maximum = 30), assessed via the Time Line Follow Back, with greater scores meaning worse outcomes.'}, {'measure': 'Sexual Distress', 'timeFrame': 'Change from overall levels of sexual dysfunction at 6 months.', 'description': 'Assessed via the Female Sexual Dysfunction Index, Minumum = 2, Maximum = 36 with higher scores meaning worse outcomes.'}, {'measure': 'Sexual Victimization', 'timeFrame': 'Reductions in severity and frequency of victimization in comparison to control at 6 months.', 'description': 'Assessed via the Sexual Experiences Survey. Scored based on frequency and severity, Minumum = 0, Maximum = 63, higher scores means worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Sex-Related Drinking Motives', 'timeFrame': 'Change in sexual related drinking motives at 6 months.', 'description': 'Assessed via 2 subscales of the Drinking Motives Questionnaire, Minimum = 8, Maximum'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use, Unspecified', 'Sexual Dysfunction', 'Sexual Assault']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to develop and evaluate the preliminary efficacy of an intervention to address alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization. The main questions it aims to answer are: 1) what is the feasibility of the recruitment method, research design, interventionist training methods, and delivery of the intervention; 2) does the intervention, relatively to control, the 2- and 6-month follow-up produces reductions in the quantity/frequency of alcohol use and heavy drinking, sexual distress, and sex-related drinking motives, and sexual revictimization. Participants will engage in both individual and group based intervention for alcohol use, sexual distress, and sexual assault risk. Follow-up assessments are completed at 2- and 6-months following program completion. The intervention will be compared to a general health promotion control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The intervention enrolls cis-gender college women.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. be between the ages of 18 and 24;\n2. speak and comprehend English;\n3. report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation or force;\n4. report exceeding the national recommended limits for daily drinking (4 or more for women) on two or more occasions in the past month;\n5. report past month sexual activity;\n6. exceed the clinical cut point on the Female Sexual Functioning Index.\n\nExclusion Criteria:\n\n1. suicide risk on the Beck Depression Inventory;\n2. screen positive on the Alcohol Use Withdrawal Checklist.'}, 'identificationModule': {'nctId': 'NCT05599620', 'acronym': 'AWARE', 'briefTitle': 'Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Lifespan'}, 'officialTitle': 'Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma', 'orgStudyIdInfo': {'id': 'R34AA028402', 'link': 'https://reporter.nih.gov/quickSearch/R34AA028402', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AWARE Program', 'description': 'The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.', 'interventionNames': ['Behavioral: AWARE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'General Health Promotion', 'description': 'The General Health Promotion program is a attention and dose-matched comparison condition.', 'interventionNames': ['Behavioral: General Health Promotion']}], 'interventions': [{'name': 'AWARE', 'type': 'BEHAVIORAL', 'description': 'AWARE addresses alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization.', 'armGroupLabels': ['AWARE Program']}, {'name': 'General Health Promotion', 'type': 'BEHAVIORAL', 'description': 'General Health Promotion is an attention and dose matched intervention with no overlapping components with AWARE.', 'armGroupLabels': ['General Health Promotion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02904', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lindsay M Orchowski, Ph.D.', 'role': 'CONTACT', 'email': 'Lindsay_Orchowski@brown.edu', 'phone': '401-444-7021'}, {'name': 'Lindsay M Orchowski, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Lindsay Orchowski', 'role': 'CONTACT', 'email': 'lindsay_orchowski@brown.edu', 'phone': '4125592936'}, {'name': 'Prachi Bhiptani', 'role': 'CONTACT', 'email': 'prachi_bhuptani@brown.edu'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The research team will submit data on or before the NDA submission due dates (April 1 and October 1 each year) in accordance with the applicable Data Sharing Terms and Conditions of award.', 'ipdSharing': 'YES', 'description': 'Data will be shared using the National Institute of Mental Health Data Archive (NDA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lifespan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor (Research)', 'investigatorFullName': 'Lindsay Orchowski Ph.D.', 'investigatorAffiliation': 'Lifespan'}}}}