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Completed

NCT Number: NCT05630118

Online Insomnia Intervention to Reduce Alcohol Use

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Alzheimer Disease Brain Diseases Central Nervous System Diseases Chemically-Induced Disorders Dementia Heavy Drinking Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Substance-Related Disorders Tauopathies

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Kentucky Psychology Research Lab

Lexington, Kentucky, 40504, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change In Alcohol Use: 1) Total Number of Drinking Days (DD)

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

    Participants reported daily alcohol use on a daily alcohol diary, including whether alcohol was consumed each day. Daily responses were used to calculate the total number of drinking days during the assessment period.

  2. Change In Alcohol Use: 2) Average Number of Drinks Per Drinking Day (DPDD).

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

    Participants will report the number of drinks consumed each day on a daily alcohol diary.

  3. Change In Alcohol Use: 3) Total Number of Drinks (TD).

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

    Participants will report the number of drinks consumed each day on a daily alcohol diary.

  4. Change In Alcohol Use: 4) Total Number of Binge Episodes (HDD)

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

    Participants will report the number of drinks consumed each day on a daily alcohol diary. Summary measures will include total number of binge episodes (4/5+ drinks for women/men) over a 10-day period.

  5. 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. Higher scores on the ISI mean worse sleep (more severe insomnia).

  6. 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. On the PSQI, higher scores mean worse sleep quality.

  7. Change In Sleep: 3) Daily Sleep Diaries

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

    Sleep Onset Latency (SOL). Participants will report how long it took them to fall asleep.

  8. Change In Sleep: 4) Daily Sleep Diaries

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

    Wake after Sleep Onset (WASO): Participants will report the number of minutes awake after falling asleep.

  9. Change in Medication Use: 5) Daily Sleep Diaries

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

    Participants will report the amount of sleep medication used each day.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Jessica Weafer

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2022
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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