Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)

Study Overview
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Brief Summary
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Insomnia is common in people who are in treatment for alcohol use disorder. It can impact both sleep quality and daytime functioning, as well as make it harder to treat the underlying alcohol use disorder. This study is looking at two types of therapy to help manage insomnia specifically for people also in treatment for alcohol use disorder.

Official Title
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Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes

Conditions
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Insomnia, Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi)
* Behavioral: Sleep Hygiene Education (SHE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet probable Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Alcohol Use Disorder with ≤12 weeks of abstinence Planned enrollment into an abstinence-based treatment program Meet probable DSM-5 criteria for chronic insomnia, confirmed with sleep diary Ability to travel to Ann Arbor for sleep laboratory assessments Access to a video chat-capable device and reliable Wi-Fi network Exclusion Criteria: Diagnosis of, or high suspicion for, sleep disorders other than insomnia Meet probable DSM-5 criteria for bipolar disorder, psychotic disorder, or post-traumatic stress disorder (PTSD) Terminal or progressive physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia), or presence of an unstable medical condition that is the specific cause of insomnia Self-reported pregnancy or intention to become pregnant during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cognitive Behavioral Therapy for insomnia (CBTi)<br>CBTi is a non-medication therapy that includes cognitive and behavioral treatment components. | Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi)<br>* CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.<br>|
| Other: Sleep Hygiene Education (SHE)<br>SHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep. | Behavioral: Sleep Hygiene Education (SHE)<br>* SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score from the insomnia severity index (ISI) | The ISI is a 7-item self-report assessment of the nature, severity and impact of insomnia. Scores range from 0-28 with higher scores suggesting more clinically significant insomnia. | Immediately post treatment | 
| Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB) | The Alcohol TLFB is an interviewer-based drinking assessment method to estimate drinking behaviors, including both frequency and quantity of consumption. | Immediately post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale | The MFI is a 20-item assessment that provides an overall fatigue score (20-100) in addition to 5 separate dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Sub-scale scores range from 4-20 with higher scores indicating higher levels of fatigue. | Immediately post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy, Sleep Hygiene