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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04564807
Other study ID # 60446
Secondary ID 1013179870
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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