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Testing an Online Insomnia Intervention

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ClinicalTrials.gov Identifier: NCT04564807
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Jessica Weafer, University of Kentucky

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Insomnia Behavioral: Web-Based Insomnia Education Program Behavioral: SHUTi Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Testing an Online Insomnia Intervention
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Web-Based Insomnia Education Program
Adult heavy drinkers with insomnia.
 Behavioral: Web-Based Insomnia Education Program
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.
Experimental: SHUTi Intervention
Adult heavy drinkers with insomnia.
 Behavioral: SHUTi Intervention
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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564807


Contacts
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Contact: Study Coordinator 859-257-5794 psychresearch@uky.edu

Locations
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United States, Kentucky
University Of Kentucky Psychology Research Lab Recruiting
Lexington, Kentucky, United States, 40504
Contact: Study Coordinator    859-257-5794    psychresearch@uky.edu   
Principal Investigator: Jessica Weafer, Ph.D.         
Sponsors and Collaborators
Jessica Weafer
Investigators
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Principal Investigator: Jessica Weafer, PhD University of Kentucky
More Information
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Responsible Party: Jessica Weafer, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04564807    
Other Study ID Numbers: 60446
1013179870 ( Other Grant/Funding Number: SUPRA )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica Weafer, University of Kentucky:
sleep
cognitive behavioral therapy
CBT
 electronic
alcohol
non-pharmacological
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Alcoholism
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
 Nervous System Diseases
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders