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Completed

NCT Number: NCT04564807

Testing an Online Insomnia Intervention

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Substance-Related Disorders

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Kentucky Psychology Research Lab

Lexington, Kentucky, 40504, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-Based Insomnia Education Program

Behavioral

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

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Jessica Weafer

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 25, 2020
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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