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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education Control | Placebo Comparator | A combination of alcohol education and sleep hygiene education comprised of four telephone-based sessions delivered over six weeks. |
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| Insomnia Treatment | Experimental | Cognitive-behavioral therapy for insomnia adapted to hazardous alcohol users comprised of four telephone-based sessions delivered over six weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfred R Pigeon, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
Deidentified data will be submitted to a data archive: the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Data Archive. The study will submit data to the National Data Archive (NDA) according to all requirements and expectations per NOT-AA-22-003.
Data to be uploaded approximately every 6 months once subject enrollment begins and will be available for as long as NDA guidelines stipulate.
To follow the criteria and guidelines as set forth by NDA.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Education Control | Behavioral | The Education Control intervention is an educational control that provides psychoeducation related to both sleep and to alcohol use. |
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| D001523 |
| Mental Disorders |