Testing an Online Insomnia Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Testing an Online Insomnia Intervention

Conditions
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Alcohol Use Disorder, Insomnia

Intervention / Treatment
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* Behavioral: Web-Based Insomnia Education Program
* Behavioral: SHUTi Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Web-Based Insomnia Education Program<br>Adult heavy drinkers with insomnia. | Behavioral: Web-Based Insomnia Education Program<br>* 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.<br>|
| Experimental: SHUTi Intervention<br>Adult heavy drinkers with insomnia. | Behavioral: SHUTi Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, cognitive behavioral therapy, CBT, electronic, alcohol, non-pharmacological