Telephone-delivered therapy for insomnia in hazardous alcohol users

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

This study is testing a new phone therapy for people who drink too much and have trouble sleeping to see if it helps them sleep better and reduce their alcohol use.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 25 Years to 64 Years
• Sex: All
• Sponsor: University of Rochester (Academic / other)
• Locations: 1 site (Rochester, New York)
• Trial ID: NCT05973955 on ClinicalTrials.gov

What this trial studies

This intervention development project aims to create and test a 4-session cognitive behavioral therapy for insomnia (CBT-I) specifically designed for individuals with hazardous alcohol use and co-occurring insomnia. The study will start with a small open-label pilot to refine the intervention, followed by a randomized trial comparing the CBT-I intervention to a control condition focused on sleep and alcohol education. The primary goals are to assess the feasibility of delivering the intervention and to evaluate its effects on insomnia severity and alcohol use. Outcomes will be measured at baseline, post-treatment, and during follow-ups at 3 and 6 months.

Who should consider this trial

Good fit: Ideal candidates for this study are adults living in New York State who exhibit hazardous alcohol use and have a diagnosis of insomnia.

Not a fit: Patients who do not have hazardous alcohol use or insomnia may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this intervention could significantly improve sleep quality and reduce alcohol use in patients with co-occurring insomnia and hazardous alcohol consumption.

How similar studies have performed: While this specific approach is novel, previous studies have shown that cognitive behavioral therapy can be effective for insomnia and may have implications for alcohol use disorders.

Eligibility criteria

Inclusion 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 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).

Exclusion Criteria:

* 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.

Where this trial is running

Rochester, New York

• University of Rochester Medical Center — Rochester, New York, United States (Recruiting)

Study contacts

• Principal investigator: Wilfred R Pigeon, PhD — University of Rochester
• Study coordinator: Wilfred R Pigeon, PhD

Conditions Insomnia; Harmful; Use, Alcohol