Online Insomnia Intervention to Reduce Alcohol Use

Jessica Weafer

Status: Active, not recruiting

Conditions: Heavy Drinking; Alcohol Use Disorder

Treatments: Behavioral: Web-Based Insomnia Education Program; Behavioral: SHUTi Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05630118

1R21AA029201-01A1 (U.S. NIH Grant/Contract)

60446-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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113 participants in 2 patient groups

SHUTi Intervention

Experimental group

Description:

Adult heavy drinkers with insomnia

Treatment:

Behavioral: SHUTi Intervention

Web-Based Insomnia Education Program

Active Comparator group

Description:

Adult heavy drinkers with insomnia

Treatment:

Behavioral: Web-Based Insomnia Education Program