Cognitive Behavioural Therapy for Alcoholism

Recruiting at 3 trial locations

Overseen By Tami Frankforter

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Suicidal ideation, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether CBT4CBT (Computer-Based Training for Cognitive Behavioral Therapy) is more effective in a church setting or a traditional clinic for treating alcohol use disorder (AUD). It compares participants' engagement and adherence to the treatment, as well as changes in their drinking habits over time. The study involves Black adults with AUD who have consumed alcohol in the last month. Participants cannot be in other substance use treatments and must be able to participate fully. As an unphased trial, this study provides a unique opportunity to explore innovative treatment settings and contribute to research that could benefit future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that CBT4CBT in the Black Church is safe for treating alcoholism?

Research shows that CBT4CBT, a computer-based therapy, receives positive feedback from participants. Studies have found that users of CBT4CBT experienced a noticeable decrease in substance use symptoms, indicating the treatment's safety. These studies have reported no major negative side effects, which supports its safety profile.

The treatment teaches skills such as managing cravings and planning for emergencies, which not only reduces alcohol use but also enhances overall coping strategies. Evidence demonstrates that CBT4CBT is both effective and safe for individuals seeking help with alcohol use issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CBT4CBT in the Black Church because it combines digital cognitive behavioral therapy (CBT) with community-based support. Unlike traditional therapy options for alcoholism, which often require in-person sessions, this approach leverages technology to deliver CBT through an online platform, making it more accessible. Additionally, integrating the program within the Black Church setting offers culturally relevant support and fosters a community-driven approach, which can enhance engagement and effectiveness. This innovative delivery model aims to make therapy more convenient and culturally resonant, potentially leading to better outcomes for individuals struggling with alcohol use.

What evidence suggests that CBT4CBT in the Black Church could be an effective treatment for alcoholism?

Research has shown that CBT4CBT, an online version of Cognitive Behavioral Therapy, effectively reduces symptoms of substance use disorders, including alcohol use. In this trial, participants will receive either the CBT4CBT program or community-based treatment as usual. Studies have found that CBT4CBT helps people improve their skills to manage cravings and avoid alcohol. Digital CBT programs match the effectiveness of face-to-face therapy in reducing alcohol use and its symptoms. The program teaches crucial skills like refusing substances and planning for emergencies, which are key to staying sober. Overall, evidence supports that CBT4CBT decreases alcohol consumption and builds skills for those seeking treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

Ayana Jordan, MD, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for Black adults with Alcohol Use Disorder (AUD) who are at least 18 years old, have had some drinking in the past month, and can speak English. They must not be currently receiving substance use treatment or have severe mental health issues like active suicidal thoughts or unstable psychotic disorders.

Inclusion Criteria

English-speaking

current AUD as their principal substance use disorder, confirmed via MINI100 interview, with some drinking in the past 28 days

Exclusion Criteria

current engagement in substance use treatment,

I am open to being assigned to any treatment group and may have a history of substance use.

I do not have thoughts of harming myself or others and do not suffer from severe mental health disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CBT4CBT in the Black Church or treatment as usual at MCCA for alcohol use disorder

8 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Follow-up assessments at 3, 6, and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• CBT4CBT in the Black Church

Trial Overview

The study is testing a new way to help people with AUD by using a program called CBT4CBT delivered in Black churches. It's being compared to traditional outpatient addiction treatments. The goal is to see which setting helps more with starting treatment, staying engaged, and reducing alcohol use over time.

How Is the Trial Designed?

Group I: CBT4CBT in the Black Church Experimental Treatment 1 Intervention

The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual: Understanding and changing patterns of alcohol use, Coping with craving, Substance refusal skills, Seemingly irrelevant decisions, Planning for emergencies, and Problem-solving skills. Staying Safe

Group II: Community Based Treatment as Usual Active Control 1 Intervention

Treatment as usual, typically groups, offered by a specialty community based treatment center (MCCA)

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

A study involving 73 individuals with substance dependence showed that those who received computer-assisted cognitive behavioral therapy (CBT4CBT) maintained lower drug use over a 6-month follow-up compared to those receiving standard treatment.

The positive effects of CBT4CBT were durable, indicating that this computer-based therapy can provide lasting benefits in reducing substance use even after treatment has ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enduring effects of a computer-assisted training program for cognitive behavioral therapy: a 6-month follow-up of CBT4CBT. Carroll, KM., Ball, SA., Martino, S., et al.[2021]

Cognitive-behavioral therapy (CBT) has strong evidence supporting its effectiveness for treating substance use disorders, but its implementation has faced challenges; computerized versions like CBT4CBT show promise in overcoming these barriers.

Clinical trials indicate that CBT4CBT effectively reduces alcohol and drug use, even with minimal clinical monitoring, and improvements in cognitive and behavioral coping skills may explain its success as a treatment mechanism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Behavioral Therapy for Substance Use Disorders: A Summary of the Evidence and Potential Mechanisms of Behavior Change. Kiluk, BD.[2023]

A study involving 63 participants found that adding computer-based cognitive behavioral therapy (CBT4CBT) to standard treatment for alcohol use disorder (AUD) was more effective and cost-effective than standard treatment alone, costing about $35.08 for each additional day of reduced drinking.

While CBT4CBT+monitoring was slightly less costly and more effective than standard treatment, overall treatment costs did not significantly differ across conditions, indicating that further research is needed to fully understand the cost-benefit of computer-delivered CBT for AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot economic evaluation of computerized cognitive behavioral therapy for alcohol use disorder as an addition and alternative to traditional therapy. Kacmarek, CN., Yates, BT., Nich, C., et al.[2023]

The study evaluated the feasibility of a computer-based cognitive behavioral therapy program (CBT4CBT) as an addition to standard residential treatment for women with substance use disorders, involving 63 participants in total (34 in the CBT4CBT group and 29 in the treatment as usual group).

Results indicated that women using CBT4CBT showed a lower likelihood of relapse, longer time to relapse, and fewer days of substance use during the 12-week follow-up, suggesting that CBT4CBT could enhance treatment outcomes in residential settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized trial of CBT4CBT for women in residential treatment for substance use disorders. Kelpin, SS., Parlier-Ahmad, AB., Jallo, N., et al.[2022]

A study involving 191 patients who completed the Alcohol Change Course (ACC) showed that 69.6% were satisfied with the program, indicating its efficacy as an Internet-delivered cognitive behavior therapy for alcohol misuse.

Patients found skills like coping with cravings and managing risky situations particularly helpful, but many suggested increasing personal interaction and providing more information to enhance the course experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving internet-delivered cognitive behaviour therapy for alcohol misuse: Patient perspectives following program completion. Hadjistavropoulos, HD., Chadwick, C., Beck, CD., et al.[2021]

In a randomized clinical trial with 101 cocaine-dependent individuals on methadone, those who had access to computer-based cognitive-behavioral therapy (CBT4CBT) were significantly more likely to achieve 3 or more consecutive weeks of abstinence from cocaine (36% vs. 17%).

The study demonstrated that CBT4CBT not only improved immediate treatment outcomes but also showed durable effects, with continued improvement observed 6 months after treatment, highlighting its potential as an effective and easily disseminable adjunct to traditional addiction treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted delivery of cognitive-behavioral therapy: efficacy and durability of CBT4CBT among cocaine-dependent individuals maintained on methadone. Carroll, KM., Kiluk, BD., Nich, C., et al.[2023]

CBT4CBT, a computer-based cognitive-behavioral therapy, was found to be a safe and effective stand-alone treatment for individuals with substance use disorders, showing significant reductions in substance use compared to standard treatment after six months.

Participants using CBT4CBT reported higher satisfaction and better understanding of cognitive and behavioral concepts than those receiving traditional clinician-delivered CBT, which had a higher dropout rate and less effectiveness at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of Computerized and Clinician-Delivered CBT in Comparison With Standard Outpatient Treatment for Substance Use Disorders: Primary Within-Treatment and Follow-Up Outcomes. Kiluk, BD., Nich, C., Buck, MB., et al.[2019]

A study involving 55 patients with alcohol use disorder showed that interactive, personalized computer-based cognitive behavioral therapy (CBT) was effective, leading to significant reductions in alcohol consumption and increased abstinence rates over a 3-month follow-up.

Both the computer-based CBT and placebo groups improved in their drinking outcomes, but the CBT group showed greater engagement in Alcoholics Anonymous and better self-efficacy regarding alcohol use, suggesting that computer-based CBT could be a valuable tool in treating AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised cognitive behavioural therapy for alcohol use disorder: a pilot randomised control trial. Farren, CK., Milnes, J., Lambe, K., et al.[2019]

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