Online Insomnia Intervention to Reduce Alcohol Use

February 3, 2026 updated by: Jessica Weafer

Testing an Online Insomnia Intervention to Reduce Alcohol Use Via Improved Sleep Among Heavy Drinkers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will investigate the efficacy of Sleep Healthy Using the Internet (SHUTi), an online insomnia intervention, in reducing alcohol consumption and improving sleep in heavy drinkers with insomnia. The participants are ages 18-50 (N=100) who have insomnia and are heavy drinkers (at least weekly binge drinking episodes [4/5+ drinks in one sitting for men/women]). This intervention has a mixed methods randomized controlled trial design. Participants will be randomly assigned to either the online SHUTi intervention (N=50), or a patient education (PE) website (N=50). Quantitative data will be collected via online REDCap surveys and daily online diaries. Qualitative data will be collected via semi-structured telephone interviews. Data collection points will be pre-intervention, post-intervention, and 3- and 6-months postintervention.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • University Of Kentucky Psychology Research Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-50 years old
  • Fluency in English
  • At least weekly binge drinking episodes (4/5+ drinks for women/men)]
  • Insomnia Severity Index (ISI) scores #15

Exclusion Criteria:

  • No internet access
  • Past or current substance use disorder (other than mild or moderate AUD)
  • Obstructive sleep apnea
  • Bipolar disorder, schizophrenia, or other psychotic spectrum disorder
  • Pregnancy or nursing for women
  • Any serious medical or neurological problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHUTi Intervention
Adult heavy drinkers with insomnia
Behavioral: SHUTi Intervention
Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
Active Comparator: Web-Based Insomnia Education Program
Adult heavy drinkers with insomnia
Behavioral: Web-Based Insomnia Education Program
Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change In Alcohol Use: Daily Alcohol Diaries
Time Frame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Participants will report the number of drinks consumed each day and proximity of alcoholic drinks to bedtime. Summary measures will include total number of drinking days, total number of drinks, average number of drinks per drinking day, and total number of binge episodes (4/5+ drinks for women/men) over a 10-day period.
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Change In Sleep: Insomnia Severity Index (ISI)
Time Frame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
The ISI uses a 7-item scale to asses insomnia impact over the previous two weeks. Items scores range from 0-28. Scores indicate moderate to severe insomnia. Moderate or marked clinical improvement is indicated by a change score of >7 or >8 respectively.
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
The PSQI indexes one-month global sleep quality using 18 items scored on a scale from 0-21. Scores # 5 indicate poor sleep quality.
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Change In Sleep: 3) Daily Sleep Diaries
Time Frame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Sleep Onset Latency (SOL). Participants will report how long it took them to fall asleep.
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Change In Sleep: 4) Daily Sleep Diaries
Time Frame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Wake after Sleep Onset (WASO): Participants will report the number of minutes awake after falling asleep.
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Change in Medication Use: 5) Daily Sleep Diaries
Time Frame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Participants will report the amount of sleep medication used each day.
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change In Mood: 1) Perceived Stress Scale (PSS)
Time Frame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
The PSS will assess perceived stress over the prior month. Scores range from 0-40. The PSS demonstrates strong concurrent and predictive validity for various health behaviors and outcomes with higher scores indicating greater psychological distress.
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Change In Mood: 2) Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10)
Time Frame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
The CESD-R-10 will index past-week depressive symptoms. Scores range from 0-30. Higher scores represent more severe symptoms.
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jessica Weafer

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Jessica Weafer, PhD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2023

Primary Completion (Actual)

July 7, 2025

Study Completion (Actual)

July 7, 2025

Study Registration Dates

First Submitted

November 17, 2022

First Submitted That Met QC Criteria

November 17, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60446-2
  • 1R21AA029201-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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