Testing an Online Insomnia Intervention
Primary Purpose
Alcohol Use Disorder, Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-Based Insomnia Education Program
SHUTi Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Use Disorder focused on measuring sleep, cognitive behavioral therapy, CBT, electronic, alcohol, non-pharmacological
Eligibility Criteria
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
Sites / Locations
- University Of Kentucky Psychology Research Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Web-Based Insomnia Education Program
SHUTi Intervention
Arm Description
Adult heavy drinkers with insomnia.
Adult heavy drinkers with insomnia.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04564807
Brief Title
Testing an Online Insomnia Intervention
Official Title
Testing an Online Insomnia Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jessica Weafer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Insomnia
Keywords
sleep, cognitive behavioral therapy, CBT, electronic, alcohol, non-pharmacological
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Web-Based Insomnia Education Program
Arm Type
Active Comparator
Arm Description
Adult heavy drinkers with insomnia.
Arm Title
SHUTi Intervention
Arm Type
Experimental
Arm Description
Adult heavy drinkers with insomnia.
Intervention Type
Behavioral
Intervention Name(s)
Web-Based Insomnia Education Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SHUTi Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Alcohol Use
Description
Alcohol use will be measured using the Timeline Follow Back (TLFB) calendar. Participants will report their drinking over the past 30 days.
Time Frame
12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Title
Change in Insomnia
Description
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.
Time Frame
12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Title
Change in Sleep Quality
Description
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.
Time Frame
12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Weafer, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Kentucky Psychology Research Lab
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Testing an Online Insomnia Intervention
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