Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
Study NCT ID:
NCT05246202
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2021-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Feedback Intervention for Latinx Drinkers With Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2022-02-14', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motivation to Reduce Alcohol Consumption Scale', 'timeFrame': 'Change from Baseline Pre PFI completion to Baseline Post PFI completion', 'description': 'The 1-item Motivation to Reduce Alcohol Consumption Scale will be used to measure current motivation/intention to reduce alcohol. Participants will be asked to select the statement that best describes their motivation/intention to reduce drinking (e.g., "I really want to cut down on drinking alcohol and intend to in the next month"). Higher scores on this measure indicate greater motivation/intention to reduce alcohol consumption (possible range (0-7).'}, {'measure': 'Modified Drinking Motives Questionnaire-Revised', 'timeFrame': 'Change from Baseline Pre PFI completion to Baseline Post PFI completion', 'description': 'The Modified Drinking Motives Questionnaire-Revised will be used to assess expectancies of drinking. For the current study, the 4-item "Coping-anxiety" subscale will be used as a measure of expectancies of drinking to reduce/cope with anxiety. The measure utilizes a 5-point Likert scale ranging from 1 (almost never/never) to 5 (almost always/always). Scores are averaged with higher scores indicating greater expectancies of drinking to reduce/cope with anxiety (possible range 1 to 5).'}, {'measure': 'Alcohol Attitudes Scale', 'timeFrame': 'Change from Baseline Pre PFI completion to Baseline Post PFI completion', 'description': 'The 7-item Alcohol Attitudes Scale will be utilized to measure maladaptive attitudes for drinking (e.g., "Drinking alcohol is good"). Items are rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). Scores will be averaged to create a composite score (possible range 1 to 7). Higher scores indicate greater maladaptive attitudes for drinking.'}], 'secondaryOutcomes': [{'measure': 'Overall Anxiety Severity and Impairment Scale', 'timeFrame': 'Change from Baseline Pre PFI Completion to 6-months Post PFI Completion', 'description': 'The 5-item Overall Anxiety Severity and Impairment Scale will be used to assess anxiety symptom severity and impairment. Each of the items is rated on a Likert-type scale ranging from 0 to 4. Items are summed to produce a total score (possible range 0 to 20).'}, {'measure': 'Alcohol Use Disorders Identification Test', 'timeFrame': 'Change from Baseline Pre PFI Completion to 6-months Post PFI Completion', 'description': 'The Alcohol Use Disorders Identification Test will be used to assess drinking quantity, craving, and related consequences to alcohol use. The 10 items are rated with various Likert-type scales. The measure produces a total score by adding all of the items of the measure with higher scores indicating greater problems with alcohol (possible range 0 to 40).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Latinx', 'Hispanic', 'Personalized Feedback Intervention'], 'conditions': ['Alcohol Abuse', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop, evaluate the acceptability/feasibility (Phase IA), and test (Phase IB) the effectiveness of a brief, integrated, single-session, computer-based, culturally adapted personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Latinx hazardous drinkers with anxiety.', 'detailedDescription': 'In the first phase, the investigators will collect qualitative and quantitative feedback from focus groups to refine intervention content and evaluate treatment acceptability and feasibility of a novel, brief, integrated, culturally adapted computer-based personalized feedback intervention (PFI). In the second phase, Latinx hazardous drinkers with clinical anxiety will be recruited and randomly assigned to either the refined culturally adapted anxiety-alcohol PFI (AA-PFI 2.0) or a control PFI (C-PFI). Initial screening will be conducted via telephone; baseline and post-treatment data will be collected in-person; and 1-, 3-, and 6-month follow-up data will be collected online remotely.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the age of 21 to 75 years of age\n* Being self-identified as Latinx or Hispanic\n* Fluent in Spanish\n* Meeting criteria for current hazardous drinking pattern\n* Meeting criteria for clinical anxiety\n* Being able to provide written, informed consent\n\nExclusion Criteria:\n\n* Being involved in alcohol or other substance use program\n* Currently pregnant\n* Current engagement in psychotherapy for anxiety'}, 'identificationModule': {'nctId': 'NCT05246202', 'briefTitle': 'Personalized Feedback Intervention for Latinx Drinkers With Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Latinx Hazardous Drinkers With Clinical Anxiety: Effectiveness Trial of a Personalized Normative Feedback Intervention', 'orgStudyIdInfo': {'id': 'STUDY00003237'}, 'secondaryIdInfos': [{'id': '1R01AA029807-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01AA029807-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0)', 'description': 'Participants complete the brief (\\~20-30 minute) AA-PFI 2.0 at baseline.', 'interventionNames': ['Behavioral: Alcohol-Anxiety Personalized Feedback Intervention 2.0']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control personalized feedback intervention (C-PFI)', 'description': 'Participants complete the brief (\\~20-30 minute) C-PFI at baseline.', 'interventionNames': ['Behavioral: Control Personalized Feedback Intervention']}], 'interventions': [{'name': 'Alcohol-Anxiety Personalized Feedback Intervention 2.0', 'type': 'BEHAVIORAL', 'otherNames': ['AA-PFI 2.0'], 'description': 'AA-PFI 2.0 is a culturally adapted, brief, computer-delivered, personalized feedback intervention to address alcohol misuse in the context of clinical anxiety.', 'armGroupLabels': ['Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0)']}, {'name': 'Control Personalized Feedback Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['C-PFI'], 'description': 'C-PFI is a brief, computer-delivered, personalized feedback intervention on exercise and nutrition.', 'armGroupLabels': ['Control personalized feedback intervention (C-PFI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77204', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aniqua Salwa, B.A.', 'role': 'CONTACT', 'email': 'asalwa@central.uh.edu', 'phone': '713-743-8056'}, {'name': 'Michael J Zvolensky, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Brooke Y Kauffman, Ph.D.', 'role': 'CONTACT', 'email': 'bkauffma@central.uh.edu', 'phone': '713-743-8056'}], 'overallOfficials': [{'name': 'Michael J Zvolensky, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data (IPD) available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Professor', 'investigatorFullName': 'Michael J. Zvolensky, Ph.D.', 'investigatorAffiliation': 'University of Houston'}}}}