Adapting CBT-I for Hazardous Alcohol Users

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05973955
Study type	Interventional
Source	University of Rochester
Contact	Wilfred R Pigeon, PhD
Phone	(585) 275-3374
Email	wilfred_pigeon@urmc.rochester.edu
Status	Recruiting
Phase	N/A
Start date	March 22, 2024
Completion date	March 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04512768` - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy	N/A
Recruiting	`NCT05963542` - Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia	N/A
Completed	`NCT06339853` - Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia	N/A
Recruiting	`NCT04069247` - Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia	N/A
Completed	`NCT04493593` - Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility	N/A
Recruiting	`NCT05956886` - Sleep Chatbot Intervention for Emerging Black/African American Adults	N/A
Recruiting	`NCT06278077` - Neurexan - a Clinical Trial in Short-Term Insomnia Patients	Phase 2
Completed	`NCT04661306` - The Better Sleep for Supporters With Insomnia Study	N/A
Recruiting	`NCT06207279` - Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Recruiting	`NCT06006299` - Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)	N/A
Completed	`NCT03683381` - App-based Intervention for Treating Insomnia Among Patients With Epilepsy	N/A
Completed	`NCT04564807` - Testing an Online Insomnia Intervention	N/A
Completed	`NCT03673397` - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression	N/A
Completed	`NCT04035200` - Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation	Phase 2
Active, not recruiting	`NCT05027438` - Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention	N/A
Recruiting	`NCT06053840` - An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia	Phase 4
Not yet recruiting	`NCT06348082` - Project Women's Insomnia Sleep Health Equity Study (WISHES)	N/A
Not yet recruiting	`NCT06363799` - Osteopathic Protocol for Insomnia in College Students	N/A
Not yet recruiting	`NCT05991492` - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application	N/A
Not yet recruiting	`NCT06025968` - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.