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

NCT06845761 | Recruiting DMC

• 2 other identifiers: 97418K99AA031309-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use; Suicidal Ideation/Behavior

Keywords

Alcohol; Cognitive Behavioral Therapy; Suicide; Remote; Self-Guided Therapy; CBT4CBT

Outcome Measures

Primary Outcomes (3)

• Change in Alcohol Use

  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

  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.

  Assessed at study week 12

• Change in Suicidal Thoughts and Behaviors

  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

Study Arms (1)

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.

Behavioral: Self-Guided Cognitive Behavioral Therapy

Interventions

Self-Guided Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)

Alcohol-Based Computer Based Training for Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mark J Rzeszutek, PhD: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40504, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking; Suicidal Ideation; Behavior; Suicide

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Drinking Behavior; Self-Injurious Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mark J Rzeszutek, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Healthier Futures Lab

CONTACT

859-533-2749; healthful@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Doctoral Scholar

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

US (1)