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

Trial Summary

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 data supports the effectiveness of the treatment CBT4CBT for alcoholism?

Research shows that CBT4CBT, a computer-based version of cognitive behavioral therapy, has been effective in reducing alcohol and drug use in various settings. It helps people learn new skills to cope with triggers for substance use, and these benefits have been shown to last even after the treatment ends. ^{1 2 3 4 5}

Is CBT4CBT safe for humans?

Research on CBT4CBT, a computer-based cognitive behavioral therapy, has shown it to be safe for people with substance use disorders, including alcohol use. Studies have not reported any significant safety concerns, making it a generally safe option for treatment. ^{2 3 5 6 7}

How is CBT4CBT different from other treatments for alcoholism?

CBT4CBT is unique because it delivers cognitive behavioral therapy (CBT) through a computer, making it more accessible and cost-effective compared to traditional in-person therapy. This approach allows for personalized, interactive sessions that can be done at the patient's convenience, potentially reaching more people who need help with alcohol use disorder. ^{2 3 5 7 8}

What is the purpose of this trial?

This study will conduct a randomized clinical trial comparing levels of treatment initiation, engagement, and alcohol outcomes for a novel treatment strategy (CBT4CBT delivered in the Black church) compared with traditional outpatient specialty addiction treatment for a large sample of Black adults with AUD. The purpose of this randomized clinical trial is to determine which setting (church or specialty clinic) (1) has better treatment initiation and retention rates and (2) better AUD outcomes as measured by percentage of days abstinent (PDA) (8 weeks, 3, 6 and 9 months follow up).

Research Team

Ayana Jordan, MD, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Enduring effects of a computer-assisted training program for cognitive behavioral therapy: a 6-month follow-up of CBT4CBT. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Computer-assisted delivery of cognitive-behavioral therapy: efficacy and durability of CBT4CBT among cocaine-dependent individuals maintained on methadone. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A pilot randomized trial of CBT4CBT for women in residential treatment for substance use disorders. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Improving internet-delivered cognitive behaviour therapy for alcohol misuse: Patient perspectives following program completion. [2021]

7. England 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Computerised cognitive behavioural therapy for alcohol use disorder: a pilot randomised control trial. [2019]