NCT05973955

Adapting CBT-I for Hazardous Alcohol Users

Addressing Hazardous and Harmful Alcohol Use Through an Adapted CBT Sleep Intervention

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 25 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The goal of this intervention development trial is to develop, refine, and test a telephone-delivered, 4-session version of cognitive behavioral therapy for insomnia adapted to hazardous alcohol users with co-occurring insomnia. The project will begin with a small, open label pilot to refine the intervention and proceed to a small, randomized trial comparing the intervention to a sleep and alcohol education control condition. The two main questions it aims to answer are whether the intervention is feasible to deliver and whether its effects on alcohol use and insomnia severity are large enough to warrant further work.

Detailed description

Drinking problems and sleep problems each cause significant loss at individual and societal levels. Insomnia in particular is highly prevalent in patients with alcohol use disorder, is prospectively associated with the development of alcohol use disorder and contributes to poorer recovery prognosis following alcohol treatments. Insomnia, therefore, represents a modifiable risk factor for negative outcomes associated with alcohol use along the full continuum of alcohol use problems. Accordingly, the project proposes to improve sleep with an insomnia intervention (cognitive behavioral therapy for insomnia) tailored to adults who meet widely accepted definitions for hazardous alcohol use as well as diagnostic criteria for insomnia disorder. An iterative approach to development, refinement, and preliminary examination of the utility of a telephone-delivered, 4-session intervention will be used. A small (N = 10), open label pilot to develop and refine procedures for administering the intervention is followed by a small (N=60), randomized trial comparing the intervention to a sleep and alcohol education control condition. A number of intervention and study design feasibility domains will be assessed in preparation for designing a larger study. The investigators will also assess the effects of the intervention on alcohol use, sleep and mood by measuring these outcomes at baseline, post-treatment, and at 3- and 6-month follow up assessments.

Conditions

• Insomnia
• Harmful; Use, Alcohol

Interventions

Type	Name	Description
BEHAVIORAL	Insomnia Treatment	The Insomnia Treatment is a version of Cognitive Behavioral Therapy for Insomnia adapted to individuals with hazardous alcohol use. It consists of the standard features of this well-established insomnia treatment in addition to adaptations that focus on alcohol use behaviors and alcohol-related thoughts that may be sleep-interfering as well as the provision of alcohol education material.
BEHAVIORAL	Education Control	The Education Control intervention is an educational control that provides psychoeducation related to both sleep and to alcohol use.

Timeline

• Start date: 2024-03-22
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2023-08-03
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States