Integration of Neurofunctional Phenotyping Into Investigation of CBT4CBT for AUD

NCT06190236 | Completed

• 1 other identifier: HM20026419
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

Alcohol use and misuse are prevalent in the United States. Alcohol use disorder (AUD) is the most common substance use disorder. Evidence-based treatments are effective; however, most people with AUD do not receive treatment, and among those who do, responses to treatment modalities vary. Technology provides the opportunity to expand treatment and improve outcomes. Therefore, the overall goal of this project is to incorporate neurofunctional phenotyping into a preliminary investigation of the feasibility of providing mobile CBT4CBT for AUD among a non-treatment seeking population

Conditions

Alcohol Abuse; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• Examine feasibility of CBT4CBT use as a mobile stand-alone intervention in a sample of non-treatment seeking people with AUD

  Use of mobile CBT4CBT outside of specialized SUD treatment settings will be feasible for participants, as measured by participants completing a mean number of 70% of modules within the 8-week CBT4CBT intervention period. The outcome variable will be the mean number of modules completed (out of 7).

  4 week check in and follow-up visit 1 (immediately after 8 week intervention period ends)

• Examine the acceptability of CBT4CBT as a mobile stand-alone intervention in a sample of non-treatment seeking people with AUD

  Use of mobile CBT4CBT outside of specialized SUD treatment settings will be acceptable for participants measured by 80% of participants reporting they are satisfied with CBT4CBT program. The outcome variable will be the mean satisfaction rating based on the following question: Overall, how satisfied are you with the intervention you received? (1, very dissatisfied to 5, very satisfied).

  4 week check in and follow-up visit 1 (immediately after 8 week intervention period ends)

Secondary Outcomes (8)

• Assess AUD outcomes (absence of heavy drinking days) utilizing the Timeline Follow Back (TLFB) in a sample of non-treatment seeking people with AUD who have access to the CBT4CBT compared to those who do not

  Follow-up study visit 1 (immediately after intervention period and follow-up study visit 2 (one month later)

• Assess AUD outcomes (recovery total score) utilizing the Substance USe Recovery Evaluator (SURE) in a sample of non-treatment seeking people with AUD who have access to the CBT4CBT compared to those who do not

  Follow-up study visit 1 (immediately after intervention period and follow-up study visit 2 (one month later)

• Evaluate sex differences in feasibility of CBT4CBT use as a mobile stand-alone intervention in a sample of non-treatment seeking people with AUD

  4 week check in and follow-up visit 1 (immediately after 8 week intervention period ends)

• Evaluate sex differences in the acceptability of CBT4CBT as a mobile stand-alone intervention in a sample of non-treatment seeking people with AUD

  Baseline, Follow-up study visit 1 (immediately after intervention period) and follow-up study visit 2 (one month later)

• Evaluate sex differences in AUD outcomes (absence of heavy drinking days) utilizing the Timeline Follow Back (TLFB) in a sample of non-treatment seeking people with AUD who have access to the CBT4CBT compared to those who do not.

  Last month of the intervention and one month following the end of the intervention

Study Arms (2)

Experimental

EXPERIMENTAL

This arm with utilize a stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorder

Behavioral: Stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorder

Control

NO INTERVENTION

No intervention

Interventions

Stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorder BEHAVIORAL

CBT4CBT is a 7-module web-delivered program based on CBT, an evidence-based behavioral treatment for alcohol use disorder (AUD).

Experimental

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 of age
• Male or female sex assigned at birth
• Meet DSM-5 Alcohol Use Disorder criteria
• report recent heavy alcohol use during the past month
• access to a smart mobile device or computer
• English-speaking.
• We are not excluding any participants based on gender identity.

You may not qualify if:

• currently receiving specialized professional SUD treatment
• presenting with language barriers, cognitive impairment, or serious medical or psychiatric illness that would preclude them from providing informed consent or participating in the ResearchMatch.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

WW Domain-Containing Oxidoreductase; Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Alcohols; Organic Chemicals

Study Officials

• Dace Svikis

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be two arms, one a control and the other arm utilizing a stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorder. This study will utilize a 3:1 randomization favoring intervention.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: January 5, 2024
• Study Start: April 10, 2024
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)