Adapting CBT-I for Hazardous Alcohol Users

NCT05973955 | Active Not Recruiting

• 1 other identifier: STUDY00008187
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Insomnia; Harmful; Use, Alcohol

Outcome Measures

Primary Outcomes (3)

• Abstinence

  The percentage of days abstinent (PDA) as measured by the Timeline Followback (TLFB)

  6 months following the baseline assessment

• Drinks per Drinking Day

  The average number of drinks per drinking day (DDD) as measured by the Timeline Followback (TLFB)

  6 months following the baseline assessment

• Insomnia Severity

  The average total score on the Insomnia Severity Index (ISI)

  6 months following the baseline assessment

Study Arms (2)

Education Control

PLACEBO COMPARATOR

A combination of alcohol education and sleep hygiene education comprised of four telephone-based sessions delivered over six weeks.

Behavioral: Education Control

Insomnia Treatment

EXPERIMENTAL

Cognitive-behavioral therapy for insomnia adapted to hazardous alcohol users comprised of four telephone-based sessions delivered over six weeks.

Behavioral: Insomnia Treatment

Interventions

Insomnia Treatment BEHAVIORAL

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.

Also known as: CBTi-HAU

Insomnia Treatment

Education Control BEHAVIORAL

The Education Control intervention is an educational control that provides psychoeducation related to both sleep and to alcohol use.

Also known as: Alcohol & Sleep Education

Education Control

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• comprehension of written and spoken English (because we are developing and testing a new intervention for which translated materials are not available);
• living in New York State (self-report);
• Alcohol Use Disorder Identification Test (AUDIT) score of 8-15 to identify alcohol use that is in the hazardous zone;
• current alcohol use (past 30 days) in excess of low-risk drinking guidelines as defined by U.S. Department of Health and Human Services and U.S. Department of Agriculture's 2015-2020 Dietary Guidelines for Americans using four items: items are 1) any use of alcohol; 2) the number of days that alcohol was used; 3) on days of alcohol use, the usual number of drinks; 4) number of days with 4/5 or more drinks on the same "occasion" defined as "at the same time or within a couple hours of each other". Based on these responses, we will determine if the individual exceeds low-risk drinking guidelines;
• Insomnia Severity Index (ISI) score \> 8; and
• meet Diagnostic and Statistical Manual of Mental Disorders (5th edition; \[DSM 5\]) criteria for Insomnia Disorder (this is evaluated by answers on the ISI supplemented by interview questions).

You may not qualify if:

• having received Cognitive Behavioral Therapy for Insomnia (by self-report and follow-up question prompts as needed);
• current or recent (past year) professional alcohol treatment (from self-report and prompts), however, participants who only report beginning alcohol treatment during the follow-up period will not be excluded from completing any remaining follow-up assessments, but this will be recorded in the data and assessed as a potential covariate.
• current or recent (past year) intravenous drug use or non-prescribed use of stimulant medications (e.g., cocaine, methamphetamines) (from TLFB and self-report question prompts);
• hospice patients, patients undergoing oncology treatment, patients with a recent or upcoming surgery and/or endorsing a serious medical or psychiatric condition item from a conditions and medications form administered by the Assessor);
• endorsing current suicidal ideation (past two weeks) with either a prior suicide attempt or being assessed at higher risk for suicide by the "P4 Screener" (a suicide risk screen used in both clinical settings and clinical trials);
• current pregnancy or intent to become pregnant during the next 6 months or given birth in the past 3 months or currently breast-feeding;
• significant sleep disorders other than insomnia such as narcolepsy or untreated sleep apnea with a Body Mass Index \> 32 (from self-report and the validated Sleep Disorders Questionnaire screening instrument) although those receiving care for sleep apnea, however, (e.g., positive airway pressure therapy) will be eligible; and
• providing false information such as false name, contact information, or study responses.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Wilfred R Pigeon, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 3, 2023
• Study Start: March 22, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data to be uploaded approximately every 6 months once subject enrollment begins and will be available for as long as NDA guidelines stipulate.
• Access Criteria: To follow the criteria and guidelines as set forth by NDA.

Locations

US (1)