Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT06845761
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2025-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Alcohol Use', 'timeFrame': 'Assessed at study week 0, 4, 8, and 12', 'description': 'Participants will complete baseline and remote follow-up assessments. Alcohol use will be measured by timeline follow-back of alcohol use for the previous 4 weeks of time of assessment. General linear mixed-effects modeling will be used to assess changes in alcohol use.'}, {'measure': 'Engagement with Self-Guided Cognitive Behavioral Therapy for Alcohol Use', 'timeFrame': 'Assessed at study week 12', 'description': 'At the end of the study, participant engagement with Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) modules will be analyzed with ordinary linear regression. Engagement will be defined as the proportion of modules completed.'}, {'measure': 'Change in Suicidal Thoughts and Behaviors', 'timeFrame': 'Assessed at study week 0, 4, 8, and 12', 'description': 'Participants will complete baseline and remote follow-up assessments. Suicidal thoughts and behaviors will be will be measured by the Colombia Suicide Severity Rating Scale. Suicidal ideation severity is measured from a scale of 0 to 25, where higher scores indicate higher levels of suicidal ideation severity. General linear mixed-effects modeling will be used to assess changes in suicidal thoughts and behaviors.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alcohol', 'Cognitive Behavioral Therapy', 'Suicide', 'Remote', 'Self-Guided Therapy', 'CBT4CBT'], 'conditions': ['Alcohol Use', 'Suicidal Ideation/Behavior']}, 'descriptionModule': {'briefSummary': 'The purpose of this single groups trial is to (Aim 1) determine relationships between alcohol use, suicidal thoughts and behaviors (STBs), and behavioral economic decision-making in a community sample (N = 100) of alcohol using adults who are 18 years of age or older, (Aim 2) is to determine factors that predict engagement with a remote intervention (computer based training for cognitive behavioral therapy; CBT4CBT) for alcohol and its effects on alcohol use, STBs, and decision-making with those same adults.\n\nParticipants will complete a baseline assessment and be given access for remote, self-guided CBT4CBT modules for alcohol use. Following this, participants will remotely complete three follow-up assessments over three months. This will allow for determination of incidence and predictors of alcohol use and STBs and determination of predictors of engagement and efficacy of a remote intervention for alcohol use in both samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old\n* Consume alcohol at least weekly\n* A score of 8 or greater on the Alcohol Use Disorder Identification Test (AUDIT)\n* Some interest in cutting back on drinking or quitting\n* Read and understand English\n\nExclusion Criteria:\n\n* A score of 31 or greater on the Alcohol Use Disorder Identification Test (AUDIT) at baseline\n* Reporting schizophrenia and/or other psychiatric diagnoses other than depression or anxiety at baseline\n* Already being in treatment for alcohol use disorder at baseline\n* Past month substance use other than cannabis or tobacco'}, 'identificationModule': {'nctId': 'NCT06845761', 'briefTitle': 'Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making', 'orgStudyIdInfo': {'id': '97418'}, 'secondaryIdInfos': [{'id': 'K99AA031309-01A1', 'link': 'https://reporter.nih.gov/quickSearch/K99AA031309-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcohol-Based Computer Based Training for Cognitive Behavioral Therapy', 'description': 'Participants in this arm will complete four assessments, one at baseline, then another three one month apart. Participants will be given access to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) at the end of their baseline session.', 'interventionNames': ['Behavioral: Self-Guided Cognitive Behavioral Therapy']}], 'interventions': [{'name': 'Self-Guided Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)'], 'description': 'Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) is a set of seven modules that consist of different skills trainings that can be accessed by devices with an internet connection. The version of CBT4CBT that will be provided is the alcohol-based CBT4CBT.', 'armGroupLabels': ['Alcohol-Based Computer Based Training for Cognitive Behavioral Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Healthier Futures Lab', 'role': 'CONTACT', 'email': 'healthful@uky.edu', 'phone': '859-533-2749'}, {'name': 'Mark Rzeszutek, PhD', 'role': 'CONTACT', 'email': 'mark.rzeszutek@uky.edu'}, {'name': 'Mark J Rzeszutek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Healthier Futures Lab', 'role': 'CONTACT', 'email': 'healthful@uky.edu', 'phone': '859-533-2749'}], 'overallOfficials': [{'name': 'Mark J Rzeszutek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'Deidentified data from this study will be made as available as possible either after the end of the funding period or after acceptance for publication, whichever comes first. All shared data will comply with HIPAA guidelines on personally identifiable information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mark J Rzeszutek, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Post Doctoral Scholar', 'investigatorFullName': 'Mark J Rzeszutek, PhD', 'investigatorAffiliation': 'University of Kentucky'}}}}