Trials / Completed
CompletedNCT05630118
Online Insomnia Intervention to Reduce Alcohol Use
Testing an Online Insomnia Intervention to Reduce Alcohol Use Via Improved Sleep Among Heavy Drinkers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 113 (actual)
- Sponsor
- Jessica Weafer · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2023-01-24
- Primary completion
- 2025-07-07
- Completion
- 2025-07-07
- First posted
- 2022-11-29
- Last updated
- 2026-02-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05630118. Inclusion in this directory is not an endorsement.