- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06845761
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making
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.
Participants 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40504
- University Of Kentucky
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 18 years old
- Consume alcohol at least weekly
- A score of 8 or greater on the Alcohol Use Disorder Identification Test (AUDIT)
- Some interest in cutting back on drinking or quitting
- Read and understand English
Exclusion Criteria:
- A score of 31 or greater on the Alcohol Use Disorder Identification Test (AUDIT) at baseline
- Reporting schizophrenia and/or other psychiatric diagnoses other than depression or anxiety at baseline
- Already being in treatment for alcohol use disorder at baseline
- Past month substance use other than cannabis or tobacco
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Alcohol-Based Computer Based Training for Cognitive Behavioral Therapy
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Alcohol Use
Time Frame: Assessed at study week 0, 4, 8, and 12
|
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.
|
Assessed at study week 0, 4, 8, and 12
|
|
Engagement with Self-Guided Cognitive Behavioral Therapy for Alcohol Use
Time Frame: Assessed at study week 12
|
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.
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Assessed at study week 12
|
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Change in Suicidal Thoughts and Behaviors
Time Frame: Assessed at study week 0, 4, 8, and 12
|
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.
|
Assessed at study week 0, 4, 8, and 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark J Rzeszutek, PhD, University Of Kentucky
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 97418
- K99AA031309-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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