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Purpose

Alcohol use disorder (AUD) inflicts enormous physical, emotional, and financial burdens on the individual and society at large. Insomnia is highly prevalent among individuals with AUD, and disrupted sleep contributes substantially to alcohol-related problems. While research suggests that treating insomnia may effectively reduce AUD, the degree to which treating insomnia in heavy drinkers reduces alcohol consumption and prevents the onset of severe AUD is not known. This study will be the first to evaluate an Internet-based version of cognitive behavioral therapy for insomnia (CBT-I) in community-dwelling, heavy drinking adults with insomnia. Sleep Healthy Using the Internet (SHUTi), the most widely-used and well-validated version of Internet-based CBT-I will be used. The primary aim is to reduce alcohol consumption and insomnia severity in this population.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 18-50 years old - Fluency in English - At least weekly binge drinking episodes (4/5+ drinks for women/men)] - Insomnia Severity Index (ISI) scores #15

Exclusion Criteria

  • No internet access - Past or current substance use disorder (other than mild or moderate AUD) - Obstructive sleep apnea - Bipolar disorder, schizophrenia, or other psychotic spectrum disorder - Pregnancy or nursing for women - Any serious medical or neurological problems

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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.
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.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University Of Kentucky Psychology Research Lab
Lexington, Kentucky 40504
Contact:
Study Coordinator
859-257-5794
psychresearch@uky.edu

More Details

NCT ID
NCT05630118
Status
Recruiting
Sponsor
Jessica Weafer

Study Contact

Study Coordinator
859-257-5794
psychresearch@uky.edu

Detailed Description

The study will investigate the efficacy of Sleep Healthy Using the Internet (SHUTi), an online insomnia intervention, in reducing alcohol consumption and improving sleep in heavy drinkers with insomnia. The participants are ages 18-50 (N=100) who have insomnia and are heavy drinkers (at least weekly binge drinking episodes [4/5+ drinks in one sitting for men/women]). This intervention has a mixed methods randomized controlled trial design. Participants will be randomly assigned to either the online SHUTi intervention (N=50), or a patient education (PE) website (N=50). Quantitative data will be collected via online REDCap surveys and daily online diaries. Qualitative data will be collected via semi-structured telephone interviews. Data collection points will be pre-intervention, post-intervention, and 3- and 6-months postintervention.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.