CBT-I for Alcoholism

Overseen By Study Coordinator

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Jessica Weafer

Disqualifiers: Substance use disorder, Sleep apnea, Bipolar, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

113 Participants Needed

Trial Summary

What is the purpose of this trial?

Alcohol use disorder (AUD) inflicts enormous physical, emotional, and financial burdens on the individual and society at large. Insomnia is highly prevalent among individuals with AUD, and disrupted sleep contributes substantially to alcohol-related problems. While research suggests that treating insomnia may effectively reduce AUD, the degree to which treating insomnia in heavy drinkers reduces alcohol consumption and prevents the onset of severe AUD is not known. This study will be the first to evaluate an Internet-based version of cognitive behavioral therapy for insomnia (CBT-I) in community-dwelling, heavy drinking adults with insomnia. Sleep Healthy Using the Internet (SHUTi), the most widely-used and well-validated version of Internet-based CBT-I will be used. The primary aim is to reduce alcohol consumption and insomnia severity in this population.

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 SHUTi Intervention, Web-Based Insomnia Education Program for alcoholism?

Research shows that cognitive-behavioral therapy (CBT) can help improve coping skills and self-efficacy (belief in one's ability to succeed) in people with alcohol use disorder, which are important for reducing alcohol consumption. Additionally, brief cognitive-behavioral interventions have been effective in treating insomnia in recovering alcoholics, suggesting that similar approaches like SHUTi may also be beneficial. ^{1 2 3 4 5}

How is the SHUTi Intervention treatment for alcoholism different from other treatments?

The SHUTi Intervention is unique because it delivers cognitive behavioral therapy (CBT) for alcohol use disorder through an interactive, personalized computer-based program, unlike traditional CBT which is typically done in person with a therapist. ^{6 7 8 9 10}

Research Team

Jessica Weafer, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for adults aged 18-50 who binge drink at least once a week and have insomnia, with an Insomnia Severity Index score of 15 or more. They must speak English fluently and have internet access. It's not for those with bipolar, schizophrenia, pregnant/nursing women, serious medical issues, other substance use disorders besides mild/moderate AUD, or obstructive sleep apnea.

Inclusion Criteria

At least weekly binge drinking episodes (4/5+ drinks for women/men)

Fluency in English

Insomnia Severity Index (ISI) scores #15

Exclusion Criteria

You have been diagnosed with bipolar disorder, schizophrenia, or other disorders that affect your thoughts and perception of reality.

Pregnancy or nursing for women

No internet access

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 9-week online insomnia intervention using SHUTi or a patient education website

9 weeks

Online participation

Follow-up

Participants are monitored for changes in alcohol use, sleep, and mood at 3- and 6-months post-intervention

24 weeks

Online surveys and telephone interviews

Treatment Details

Interventions

• SHUTi Intervention
• Web-Based Insomnia Education Program

Trial Overview The study tests if an online program called SHUTi can help heavy drinkers sleep better and reduce their alcohol intake. SHUTi is a web-based version of cognitive behavioral therapy specifically designed to improve insomnia without face-to-face sessions.

Participant Groups

Group I: SHUTi Intervention Experimental Treatment 1 Intervention

Adult heavy drinkers with insomnia

Group II: Web-Based Insomnia Education Program Active Control 1 Intervention

Adult heavy drinkers with insomnia

Who Is Running the Clinical Trial?

Jessica Weafer

Lead Sponsor

Trials

5

Recruited

560+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

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]

Coping-skills training (CST) has been shown to be more effective than other treatments in reducing the frequency and severity of relapses in alcoholics, by enhancing patients' abilities to handle high-risk situations for drinking.

Cue-exposure treatment (CET) allows patients to confront alcohol-related cues in a controlled environment, helping them practice coping responses, and preliminary studies suggest it leads to reduced drinking severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping-skills training and cue-exposure therapy in the treatment of alcoholism. Monti, PM., Rohsenow, DJ.[2019]

A review of ten studies on cognitive-behavioral treatment (CBT) for alcohol dependence found little evidence supporting the idea that CBT works by enhancing coping skills.

The effectiveness of CBT in treating alcohol dependence remains unclear, suggesting that either previous studies had methodological issues or that the underlying assumptions of CBT may need to be reevaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment for alcohol dependence: a review of evidence for its hypothesized mechanisms of action. Morgenstern, J., Longabaugh, R.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Assertive Community Treatment For People With Alcohol Dependence: A Pilot Randomized Controlled Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Changes in Hypothesized Mechanisms of Change Before and After Initiating Abstinence in Cognitive-Behavioral Therapy for Women With Alcohol Use Disorder. [2020]

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

Communication skills training, communication skills training with family and cognitive behavioral mood management training for alcoholics. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Naltrexone and cue exposure with coping and communication skills training for alcoholics: treatment process and 1-year outcomes. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of brief cognitive-behavioural interventions for insomnia in recovering alcoholics. [2018]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Ireland pubmed.ncbi.nlm.nih.gov

The effects of combined acamprosate and integrative behaviour therapy in the outpatient treatment of alcohol dependence: a randomized controlled trial. [2018]

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

Drink refusal training as part of a combined behavioral intervention: effectiveness and mechanisms of change. [2021]

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

Coping-skills training and cue-exposure therapy in the treatment of alcoholism. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment for alcohol dependence: a review of evidence for its hypothesized mechanisms of action. [2019]