Clinical trial NCT05630118: Online Insomnia Intervention to Reduce Alcohol Use
Official title: Testing an Online Insomnia Intervention to Reduce Alcohol Use Via Improved Sleep Among Heavy Drinkers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Heavy Drinking
Keywords: Sleep
Cognitive Behavioral Therapy
CBT
Alcohol
App
Non Pharmacological
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-11-29
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change In Alcohol Use: Daily Alcohol Diaries
timeFrame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
measure: Change In Sleep: Insomnia Severity Index (ISI)
timeFrame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
measure: Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
measure: Change In Sleep: 3) Daily Sleep Diaries
timeFrame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
measure: Change In Sleep: 4) Daily Sleep Diaries
timeFrame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
measure: Change in Medication Use: 5) Daily Sleep Diaries
timeFrame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Secondary outcomes:
measure: Change In Mood: 1) Perceived Stress Scale (PSS)
timeFrame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
measure: Change In Mood: 2) Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10)
timeFrame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University Of Kentucky Psychology Research Lab
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jessica Weafer, PhD
role: PRINCIPAL_INVESTIGATOR
References: