Online Insomnia Intervention to Reduce Alcohol Use

NCT05630118 | Completed

• 2 other identifiers: 60446-21R21AA029201-01A1
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder; Heavy Drinking

Keywords

Sleep; Cognitive Behavioral Therapy; CBT; Alcohol; App; Non Pharmacological

Outcome Measures

Primary Outcomes (6)

• Change In Alcohol Use: Daily Alcohol Diaries

  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)

  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)

  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

  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

  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

  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 Outcomes (2)

• Change In Mood: 1) Perceived Stress Scale (PSS)

  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)

  33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)

Study Arms (2)

SHUTi Intervention

EXPERIMENTAL

Adult heavy drinkers with insomnia

Behavioral: SHUTi Intervention

Web-Based Insomnia Education Program

ACTIVE COMPARATOR

Adult heavy drinkers with insomnia

Behavioral: Web-Based Insomnia Education Program

Interventions

Web-Based Insomnia Education Program BEHAVIORAL

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.

Web-Based Insomnia Education Program

SHUTi Intervention BEHAVIORAL

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.

SHUTi Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessica Weafer: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University Of Kentucky Psychology Research Lab

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Alcoholism; Alzheimer Disease

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Jessica Weafer, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 29, 2022
• Study Start: January 24, 2023
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)