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Clinical Trials/NCT06845761
NCT06845761CompletedNot Applicable

Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making

Mark J Rzeszutek, PhD1 site in 1 country102 target enrollmentStarted: May 9, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
102
Locations
1
Primary Endpoint
Change in Alcohol Use

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Alcohol-Based Computer Based Training for Cognitive Behavioral Therapy

Experimental

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.

Intervention: Self-Guided Cognitive Behavioral Therapy (Behavioral)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Mark J Rzeszutek, PhD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mark J Rzeszutek, PhD

Post Doctoral Scholar

University of Kentucky

Study Sites (1)

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