Testing an Online Insomnia Intervention

Insomnia Clinical Trial

Official title:

Testing an Online Insomnia Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04564807
• Other study ID #: 60446
• Secondary ID: 1013179870
• Status: Completed
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: October 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• engage in weekly alcohol binge episodes
• moderate to severe insomnia

Exclusion Criteria:

• history of severe alcohol or other substance use disorder
• obstructive sleep apnea
• schizophrenia
• bipolar disorder
• psychotic spectrum disorder
• lack of internet access
• lack of English fluency
• pregnant or nursing

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Insomnia
• Sleep Initiation and Maintenance Disorders

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.
• 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.

Locations

Country	Name	City	State
United States	University Of Kentucky Psychology Research Lab	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Jessica Weafer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alcohol Use	Alcohol use will be measured using the Timeline Follow Back (TLFB) calendar. Participants will report their drinking over the past 30 days.	12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Primary	Change in Insomnia	Insomnia will be measured using the Insomnia Severity Index (ISI). This survey has 7 questions related to insomnia. Scores range from 0-28, with higher scores indicating increased insomnia.	12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Primary	Change in Sleep Quality	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). It measures seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Scores range from 0-indefinite. A score greater than 5 is indicative of poor sleep quality.	12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)