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Adapting CBT-I for Hazardous Alcohol Users

NCT05973955 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Wilfred R Pigeon, PhD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-22
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05973955 on ClinicalTrials.gov