Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)
2 other identifiers
interventional
134
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
November 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedMarch 9, 2026
July 1, 2025
5.4 years
June 29, 2020
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale
Immediately post treatment
Study Arms (2)
Cognitive Behavioral Therapy for insomnia (CBTi)
OTHERCBTi is a non-medication therapy that includes cognitive and behavioral treatment components.
Sleep Hygiene Education (SHE)
OTHERSHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep.
Interventions
SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
Eligibility Criteria
You may qualify if:
- Meet probable Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Alcohol Use Disorder with ≤12 months of abstinence
- Planned enrollment into an abstinence-based treatment program
- Meet probable DSM-5 criteria for chronic insomnia
- Access to a video chat-capable device and reliable Wi-Fi network
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J Todd Arnedt, Ph.D.
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
June 29, 2020
First Posted
July 7, 2020
Study Start
November 12, 2020
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
March 9, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The data will be available following data collection and for 1-2 years following the end of the study grant.
- Access Criteria
- Data shared via the NIMH database is accessible by those associated with NIH institutions who have also signed data sharing agreements.
De-identified data will be shared through the National Institute of Mental Health (NIMH) Data Archive. Only information relevant to the research project will be shared, which may include demographic information such as gender and age, responses to surveys and results found from the research project. Participants identifying data will not be shared in any way and information related to participants will be given a different random identifier known as a Global Unique Identifier or GUID. This number will not coincide with any identifier for data stored on University of Michigan study databases.