Testing an Online Insomnia Intervention

Not Applicable

Completed

• Conditions: Alcohol Use Disorder; Insomnia
• Interventions: Behavioral: SHUTi Intervention; Behavioral: Web-Based Insomnia Education Program

• Registration Number: NCT04564807
• Lead Sponsor: Jessica Weafer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study Start: 2020-09-25
• Study First Posted: 2020-09-25
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHUTi Intervention	SHUTi Intervention	Adult heavy drinkers with insomnia.
Web-Based Insomnia Education Program	Web-Based Insomnia Education Program	Adult heavy drinkers with insomnia.

Primary Outcome Measures

Name	Time	Method
Change in Insomnia	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	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	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.

Trial Locations

Locations (1)

University Of Kentucky Psychology Research Lab; 🇺🇸 Lexington, Kentucky, United States