Clinical trial NCT06190236: Integration of Neurofunctional Phenotyping Into Investigation of CBT4CBT for AUD
Official title: Integration of Neurofunctional Phenotyping Into a Preliminary Investigation of Stand-alone Web-based Cognitive Behavioral Therapy (CBT4CBT) for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Alcohol Use Disorder
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Examine feasibility of CBT4CBT use as a mobile stand-alone intervention in a sample of non-treatment seeking people with AUD
timeFrame: 4 week check in and follow-up visit 1 (immediately after 8 week intervention period ends)
measure: Examine the acceptability of CBT4CBT as a mobile stand-alone intervention in a sample of non-treatment seeking people with AUD
timeFrame: 4 week check in and follow-up visit 1 (immediately after 8 week intervention period ends)
Secondary outcomes:
measure: 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
timeFrame: Follow-up study visit 1 (immediately after intervention period and follow-up study visit 2 (one month later)
measure: 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
timeFrame: Follow-up study visit 1 (immediately after intervention period and follow-up study visit 2 (one month later)
measure: Evaluate sex differences in feasibility of CBT4CBT use as a mobile stand-alone intervention in a sample of non-treatment seeking people with AUD
timeFrame: 4 week check in and follow-up visit 1 (immediately after 8 week intervention period ends)
measure: Evaluate sex differences in the acceptability of CBT4CBT as a mobile stand-alone intervention in a sample of non-treatment seeking people with AUD
timeFrame: Baseline, Follow-up study visit 1 (immediately after intervention period) and follow-up study visit 2 (one month later)
measure: 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.
timeFrame: Last month of the intervention and one month following the end of the intervention
measure: 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.
timeFrame: Last month of the intervention and one month following the end of the intervention
measure: Examine associations between ANA neurofunctional and social domains at baseline
timeFrame: Last month of the intervention and one month following the end of the intervention
measure: Examine absence of heavy drinking days after access to the CBT4CBT program in a sample of non-treatment seeking people with AUD.
timeFrame: Last month of the intervention and one month following the end of the intervention
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Dace Svikis
role: PRINCIPAL_INVESTIGATOR
References: