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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether treating insomnia can reduce alcohol consumption in adults who drink heavily. It will use an Internet-based cognitive behavioral therapy program called SHUTi (Sleep Healthy Using The Internet) to help participants improve their sleep. The study seeks to determine if better sleep can lead to reduced alcohol use and prevent more severe drinking problems. Ideal participants are adults who binge drink at least weekly and have trouble sleeping. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve sleep and reduce alcohol consumption.

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 this Internet-based CBT-I is safe for heavy drinkers with insomnia?

Research has shown that SHUTi, an online therapy for insomnia, is user-friendly. In past studies, participants using SHUTi reported significantly better sleep quality, with no major negative effects linked to the treatment.

One study found that SHUTi not only improved sleep but also helped reduce alcohol use in individuals whose insomnia was related to alcohol and opioid use. Another study confirmed these results, showing similar sleep improvements to other insomnia treatments.

Overall, evidence suggests that SHUTi is a safe choice for individuals with insomnia, even for those who drink heavily. It effectively improves sleep without causing significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SHUTi Intervention because it offers a digital, tailored approach to managing insomnia specifically in adults struggling with alcohol use. Unlike traditional treatments that might rely on medication or in-person therapy, SHUTi is an online cognitive behavioral therapy for insomnia (CBT-I) that provides interactive, personalized support. This method could be more accessible and convenient, potentially reaching individuals who might not seek help otherwise. Additionally, the focus on insomnia in heavy drinkers addresses a critical aspect of alcohol recovery, which can significantly impact overall treatment success.

What evidence suggests that this trial's treatments could be effective for alcohol use disorder?

Research has shown that the SHUTi program, an online therapy for insomnia, can significantly reduce sleep problems and help heavy drinkers reduce alcohol consumption. In this trial, participants will receive either the SHUTi Intervention or a Web-Based Insomnia Education Program. One study found that people using SHUTi experienced fewer sleep issues and drank less alcohol compared to those who did not use the program. Another study involving individuals with alcohol use disorder found that computer-based therapy effectively addressed these issues. These findings suggest that SHUTi might help people drink less by improving their sleep. ^{1 6 7 8}

Who Is on the Research Team?

Jessica Weafer, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03493958

RCT of Web-Based Behavioral Sleep Intervention for ...

This is a two-phase randomized controlled trial assessing feasibility/acceptability and effectiveness of the SHUTi program for research participants.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10842053/

Effects of a digital cognitive behavioral therapy for ...

Linear mixed effects models showed that SHUTi significantly reduced insomnia symptoms (p = 0.01) and drinking outcomes (ps < 0.05) relative to the control ...

3.

withpower.com

withpower.com/trial/phase-alcoholism-11-2022-c860e

CBT-I for Alcoholism · Info for Participants

A study involving 55 patients with alcohol use disorder showed that interactive, personalized computer-based cognitive behavioral therapy (CBT) was effective, ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2215036615005362

Effectiveness of an online insomnia program (SHUTi) for ...

Major depressive disorder was diagnosed in 22 (4%) participants at 6 months (n=9 in the SHUTi group and n=13 in the HealthWatch group), with no superior effect ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11408456/

Treatment of insomnia associated with alcohol and opioid use

SHUTi significantly alleviated symptoms of insomnia compared to patient education, and unlike the first three RCTs, the intervention reduced alcohol consumption ...

6.

jamanetwork.com

jamanetwork.com/journals/jamapsychiatry/fullarticle/483124

Efficacy of an Internet-Based Behavioral Intervention for ...

The improvements in sleep after using SHUTi are very similar to those from other insomnia treatment outcome trials. In fact, the percentage of change in sleep ...

7.

pilotfeasibilitystudies.biomedcentral.com

pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-018-0376-3

Online cognitive behavioral therapy for insomnia (CBT-I) for ...

This is a two-phase RCT assessing feasibility/acceptability and efficacy of the SHUTi program among individuals with AUD in recovery with insomnia.

8.

as.uky.edu

as.uky.edu/uk-researchers-are-first-track-app%E2%80%99s-effect-heavy-drinkers-insomnia

UK researchers are first to track app's effect on heavy drinkers ...

“We might be able to reach people with this insomnia intervention that might not necessarily seek out treatment for alcohol use disorder," ...