Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Cognitive Behavioral Therapy for insomnia (CBTi) CBTi is a non-medication therapy that includes cognitive and behavioral treatment components. |
Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi)
CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
|
| Other: Sleep Hygiene Education (SHE) 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)
SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
|
Outcome Measures
Primary Outcome Measures
- Score from the insomnia severity index (ISI) [Immediately post treatment]
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.
- Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB) [Immediately post treatment]
The Alcohol TLFB is an interviewer-based drinking assessment method to estimate drinking behaviors, including both frequency and quantity of consumption.
Secondary Outcome Measures
- Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale [Immediately post treatment]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Meet probable Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Alcohol Use Disorder with ≤12 weeks of abstinence
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Planned enrollment into an abstinence-based treatment program
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Meet probable DSM-5 criteria for chronic insomnia, confirmed with sleep diary
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Ability to travel to Ann Arbor for sleep laboratory assessments
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Access to a video chat-capable device and reliable Wi-Fi network
Exclusion Criteria:
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Diagnosis of, or high suspicion for, sleep disorders other than insomnia
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Meet probable DSM-5 criteria for bipolar disorder, psychotic disorder, or post-traumatic stress disorder (PTSD)
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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
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Self-reported pregnancy or intention to become pregnant during the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: J Todd Arnedt, Ph.D., University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00173631
- R01AA028158