Alcohol AbuseNCT06190236
Integration of Neurofunctional Phenotyping Into Investigation of CBT4CBT for AUD
A study testing Stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorder in people with Alcohol Abuse and Alcohol Use Disorder, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse, Alcohol Use Disorder
- What is being tested?
- Stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 22 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: 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
Read the 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.
- Conditions
- Alcohol Abuse, Alcohol Use Disorder
- Being tested
- Stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorderBehavioural
CBT4CBT is a 7-module web-delivered program based on CBT, an evidence-based behavioral treatment for alcohol use disorder (AUD).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | This arm with utilize a stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorder Receives: Behavioral: Stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorder |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
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).
Measured: 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
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.
Measured: 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
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).
Measured: 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
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).
Measured: 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.
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.
Measured: 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.
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.
Measured: Last month of the intervention and one month following the end of the intervention
Examine associations between ANA neurofunctional and social domains at baseline
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).
Measured: 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.
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)
Measured: Last month of the intervention and one month following the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start10 Apr 2024
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dace Svikis, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190236
- Sponsor's protocol ID
- HM20026419
- Status last verified
- Jun 2025
- First submitted
- 20 Nov 2023
- Last updated
- 8 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Neurofunctional Phenotyping Into a Preliminary Investigation of Stand-alone Web-based Cognitive Behavioral Therapy (CBT4CBT) for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06190236
- Acronym / sponsor ID
- HM20026419
- Conditions
- Alcohol Abuse, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorderThis arm with utilize a stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorder |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorderCBT4CBT is a 7-module web-delivered program based on CBT, an evidence-based behavioral treatment for alcohol use disorder (AUD). | Behavioural | Experimental |
Primary outcome
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).
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).
8 secondary outcomes
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)
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)
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)
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)
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dace Svikis principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stand-alone web-based cognitive behavioral therapy (CBT4CBT) for alcohol use disorder in people with Alcohol Abuse and Alcohol Use Disorder, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.