Alcohol Use DisorderNCT05630118
Online Insomnia Intervention to Reduce Alcohol Use
A study testing SHUTi Intervention and Web-Based Insomnia Education Program in people with Alcohol Use Disorder and Heavy Drinking, run by Jessica Weafer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Heavy Drinking
- What is being tested?
- SHUTi Intervention and Web-Based Insomnia Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2023to 7 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Kentucky Psychology Research Lab
Lexington, Kentucky, 40504
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use Disorder, Heavy Drinking
- Being tested
- SHUTi Intervention, Web-Based Insomnia Education Program
- Keywords
- Sleep, Cognitive Behavioral Therapy, CBT, Alcohol, App, Non Pharmacological
- Medical subject headings
- Alcoholism, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHUTi InterventionBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SHUTi Intervention | Experimental | Adult heavy drinkers with insomnia Receives: Behavioral: SHUTi Intervention |
| Web-Based Insomnia Education Program | Active comparator | Adult heavy drinkers with insomnia Receives: Behavioral: Web-Based Insomnia Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In Alcohol Use: 1) Total Number of Drinking Days (DD)
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.
Measured: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Change In Alcohol Use: 2) Average Number of Drinks Per Drinking Day (DPDD).
Participants will report the number of drinks consumed each day on a daily alcohol diary.
Measured: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Change In Alcohol Use: 3) Total Number of Drinks (TD).
Participants will report the number of drinks consumed each day on a daily alcohol diary.
Measured: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Change In Alcohol Use: 4) Total Number of Binge Episodes (HDD)
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.
Measured: 33 weeks (baseline, at the end of the 9-week intervention, 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. Higher scores on the ISI mean worse sleep (more severe insomnia).
Measured: 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. On the PSQI, higher scores mean worse sleep quality.
Measured: 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.
Measured: 33 weeks (baseline, at the end of the 9-week intervention, 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.
Measured: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Change in Medication Use: 5) Daily Sleep Diaries
Participants will report the amount of sleep medication used each day.
Measured: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Secondary outcomes (2)
Change In Mood: 1) Perceived Stress Scale (PSS)
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.
Measured: 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)
The CESD-R-10 will index past-week depressive symptoms. Scores range from 0-30. Higher scores represent more severe symptoms.
Measured: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start24 Jan 2023
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessica Weafer
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Jessica Weafer, Ohio State University
- Investigators
- Jessica Weafer, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630118
- Sponsor's protocol ID
- 60446-2
- Other IDs
- 1R21AA029201-01A1
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2022
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Online Insomnia Intervention to Reduce Alcohol Use Via Improved Sleep Among Heavy Drinkers
- ClinicalTrials.gov ID
- NCT05630118
- Acronym / sponsor ID
- 60446-2
- Conditions
- Alcohol Use Disorder, Heavy Drinking
- Keywords
- Sleep, Cognitive Behavioral Therapy, CBT, Alcohol, App, Non Pharmacological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Jessica WeaferUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Posted 15 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHUTi Intervention | Experimental | Behavioral: SHUTi InterventionAdult heavy drinkers with insomnia |
| Web-Based Insomnia Education Program | Active comparator | Behavioral: Web-Based Insomnia Education ProgramAdult heavy drinkers with insomnia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHUTi InterventionSleep 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. | Behavioural | SHUTi Intervention |
| Web-Based Insomnia Education ProgramParticipants 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. | Behavioural | Web-Based Insomnia Education Program |
Primary outcome
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.
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.
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.
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.
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).
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.
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.
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.
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.
2 secondary outcomes
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Weafer, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHUTi Intervention and Web-Based Insomnia Education Program in people with Alcohol Use Disorder and Heavy Drinking, run by Jessica Weafer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.