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Clinical Trials/NCT04564807
NCT04564807
Completed
N/A

Testing an Online Insomnia Intervention

Jessica Weafer1 site in 1 country71 target enrollmentSeptember 25, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alcohol Use Disorder
Sponsor
Jessica Weafer
Enrollment
71
Locations
1
Primary Endpoint
Change in Insomnia
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 25, 2020
End Date
May 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jessica Weafer
Responsible Party
Sponsor Investigator
Principal Investigator

Jessica Weafer

Assistant Professor

University of Kentucky

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

Outcomes

Primary Outcomes

Change in Insomnia

Time Frame: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)

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

Time Frame: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)

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.

Change in Alcohol Use

Time Frame: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)

Alcohol use will be measured using the Timeline Follow Back (TLFB) calendar. Participants will report their drinking over the past 30 days.

Study Sites (1)

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