NCT04564807

Testing an Online Insomnia Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Jessica Weafer · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this trial is to determine the effectiveness of an electronic cognitive behavioral therapy for insomnia (e-CBT-I) module in improving sleep and reducing alcohol use among heavy drinkers with insomnia. Specifically, it will test the effectiveness of Sleep Healthy Using the Internet (SHUTi), a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. The rationale for this mixed methods proposal is that effective, nonpharmacologic treatments are necessary to stem the highly comorbid public health problems of alcohol use disorder (AUD) and insomnia. If successful, SHUTi will represent a novel and easily accessible intervention for reducing alcohol intake among high-risk heavy drinkers.

Conditions

• Alcohol Use Disorder
• Insomnia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2020-09-25
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2020-09-25
• Last updated: 2022-10-25

Locations

1 site across 1 country: United States