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

Not Applicable

Recruiting

• Conditions: Insomnia; Alcohol Use Disorder
• Interventions: Behavioral: Sleep Hygiene Education (SHE); Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi)

• Registration Number: NCT04457674
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-07
• Study Start: 2020-11-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Hygiene Education (SHE)	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.
Cognitive Behavioral Therapy for insomnia (CBTi)	Cognitive Behavioral Therapy for insomnia (CBTi)	CBTi is a non-medication therapy that includes cognitive and behavioral treatment components.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States