RECRUITING

Adapting CBT-I for Hazardous Alcohol Users

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-22

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05973955

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* comprehension of written and spoken English (because we are developing and testing a new intervention for which translated materials are not available); * living in Monroe County, NY which includes and surrounds the city of Rochester or adjacent surrounding Counties (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).	* 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.

Inclusion Criteria

Exclusion Criteria

* comprehension of written and spoken English (because we are developing and testing a new intervention for which translated materials are not available);
* living in Monroe County, NY which includes and surrounds the city of Rochester or adjacent surrounding Counties (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).

* 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.

Contacts and Locations

Study Contact

Wilfred R Pigeon, PhD

CONTACT

(585) 275-3374

wilfred_pigeon@urmc.rochester.edu

Principal Investigator

Wilfred R Pigeon, PhD

PRINCIPAL_INVESTIGATOR

University of Rochester

Study Locations (Sites)

University of Rochester Medical Center

Rochester, New York, 14642

United States

Collaborators and Investigators

Sponsor: University of Rochester

Wilfred R Pigeon, PhD, PRINCIPAL_INVESTIGATOR, University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-22

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-03-22

Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

Insomnia
Harmful; Use, Alcohol