Integration of Neurofunctional Phenotyping Into Investigation of CBT4CBT for AUD

June 6, 2025 updated by: Virginia Commonwealth University

Integration of Neurofunctional Phenotyping Into a Preliminary Investigation of Stand-alone Web-based Cognitive Behavioral Therapy (CBT4CBT) for Alcohol Use Disorder

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Nationally, alcohol is the third leading preventable cause of death. In 2019, 14.1 million adults had an alcohol use disorder (AUD). However, most people with AUD do not receive treatment, and treatments are only moderately effective among those who do receive treatment largely due to the heterogeneity of people with AUD. Precision medicine is a method to guide tailoring individual treatment regimens and improve outcomes in evidence-based treatments. Recently, neurofunctional phenotyping approaches have emerged as a promising avenue to advance precision medicine in AUD. For example, studies of the Addictions Neuroclinical Assessment (ANA) framework-a neuroscience-based framework that uses three neurofunctional domains that are considered critical to the development and maintenance of AUD-suggest there are associations between ANA domains and drinking behavior. However, the utility of phenotyping approaches has not been investigated in behavioral treatment modalities for AUD. Additionally, although AUD is the most common substance use disorder (SUD), fewer people in need of AUD treatment receive it compared to treatment for other use disorders. Many of these individuals, particularly those with mild AUD, can reduce or cease alcohol use without specialized treatment. However, efforts to refer those with more severe AUD to community residential or outpatient programs have been largely unsuccessful, especially among women who often face practical barriers like lack of transportation and childcare. Technology offers innovative opportunities to make treatment more readily accessible to those in need. Computer-Based Training for Cognitive Behavioral Therapy (CBT4CBT) is a web-based intervention with demonstrated effectiveness as an adjunct to standard AUD and other drug use disorder treatment programming. To-date, however, it has not been tested with non-treatment seeking men and women with AUD. For the proposed study, a sample of non-treatment seeking people with AUD will be recruited using ResearchMatch.org and randomized (3:1) to complete the mobile CBT4CBT program or an assessment only control condition stratified by sex (N=248 total; females: n=93 CBT4CBT, n=31 Control; males: n=93 CBT4CBT, n=31 Control). Feasibility and acceptability of CBT4CBT will be assessed among participants in the CBT4CBT condition. Study assessments that include self-reported AUD outcomes and neurofunctional assessments will be administered to all participants at baseline, immediately post-intervention, and at one month following the intervention period. All outcomes will also be assessed for sex differences using sex-stratified analyses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Anna B Parlier

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
No intervention
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
CBT4CBT is a 7-module web-delivered program based on CBT, an evidence-based behavioral treatment for alcohol use disorder (AUD).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Examine feasibility of CBT4CBT use as a mobile stand-alone intervention in a sample of non-treatment seeking people with AUD
Time Frame: 4 week check in and follow-up visit 1 (immediately after 8 week intervention period ends)
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
Time Frame: 4 week check in and follow-up visit 1 (immediately after 8 week intervention period ends)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Follow-up study visit 1 (immediately after intervention period and follow-up study visit 2 (one month later)
Participants in the CBT4CBT condition will be less likely to report any heavy drinking days during the last month of the intervention period and during the month following the end of the intervention than those in the control condition based on the TLFB. The TLFB measures the quantity and frequency of past month alcohol use. The outcome variable will be absence of heavy drinking days (yes/no).
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
Time Frame: Follow-up study visit 1 (immediately after intervention period and follow-up study visit 2 (one month later)
Participants in the CBT4CBT condition will report higher total scores on the SURE during the last month of the intervention period and during the month following the end of the intervention than those in the control condition based on the TLFB. The SURE is a 21-item measure of holistic recovery. Total scores range from 21 to 63 with higher scores indicating better recovery. The outcome variable will be the total score on the SURE.
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
Time Frame: 4 week check in and follow-up visit 1 (immediately after 8 week intervention period ends)
In the CBT4CBT condition, females will complete more CBT4CBT on average than males. 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)
Evaluate sex differences in the acceptability of CBT4CBT as a mobile stand-alone intervention in a sample of non-treatment seeking people with AUD
Time Frame: Baseline, Follow-up study visit 1 (immediately after intervention period) and follow-up study visit 2 (one month later)
In the CBT4CBT condition, females will report higher mean satisfaction ratings for CBT4CBT than males. 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).
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.
Time Frame: Last month of the intervention and one month following the end of the intervention
Participants in the CBT4CBT condition will be less likely to have any heavy drinking days than the control group during the last month of the intervention period and during the month following the end of the intervention for both males and females.
Last month of the intervention and one month following the end of the intervention
Evaluate sex differences in 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.
Time Frame: Last month of the intervention and one month following the end of the intervention
Participants in the CBT4CBT condition will have higher recovery scores based on the SURE than the control group during the last month of the intervention period and during the month following the end of the intervention for both males and females.
Last month of the intervention and one month following the end of the intervention
Examine associations between ANA neurofunctional and social domains at baseline
Time Frame: Last month of the intervention and one month following the end of the intervention
Associations between domains and absence of heavy drinking days (yes/no) during the last month of the intervention period and during the month following the end of the intervention will vary by domain (i.e., negative emotionality, incentive salience, executive function, and social environment). Domains will be assessed using the ANA Domains Brief Scale (ANA Brief, 15-items, higher scores indicate greater impairment) and the Health Leads Social Needs Survey (HLSN, 8-items, higher scores indicate greater impairment).
Last month of the intervention and one month following the end of the intervention
Examine absence of heavy drinking days after access to the CBT4CBT program in a sample of non-treatment seeking people with AUD.
Time Frame: Last month of the intervention and one month following the end of the intervention
Associations between domains and absence of heavy drinking days (yes/no) during the last month of the intervention period and during the month following the end of the intervention will vary by domain (i.e., negative emotionality, incentive salience, executive function, and social environment)
Last month of the intervention and one month following the end of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dace Svikis, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM20026419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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