Testing an Online Insomnia Intervention
2 other identifiers
interventional
71
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2020
CompletedFirst Posted
Study publicly available on registry
September 25, 2020
CompletedStudy Start
First participant enrolled
September 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedOctober 25, 2022
October 1, 2022
1.7 years
September 22, 2020
October 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
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)
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)
Study Arms (2)
Web-Based Insomnia Education Program
ACTIVE COMPARATORAdult heavy drinkers with insomnia.
SHUTi Intervention
EXPERIMENTALAdult heavy drinkers with insomnia.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- engage in weekly alcohol binge episodes
- moderate to severe insomnia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jessica Weaferlead
Study Sites (1)
University Of Kentucky Psychology Research Lab
Lexington, Kentucky, 40504, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Weafer, PhD
University of Kentucky
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 22, 2020
First Posted
September 25, 2020
Study Start
September 25, 2020
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
October 25, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share