Online Insomnia Intervention to Reduce Alcohol Use

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

Trial locations and contacts

1 site in 1 country.

About this study

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

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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)

2. 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)

3. 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)

4. 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)

5. 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)

6. 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)

7. 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)

8. 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)

9. 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Nov 2022
2. Study start24 Jan 2023
3. Primary completion7 Jul 2025
4. 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.