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Cognitive Behavioral Therapy for Insomnia in Alcohol Use Disorder

N/A
Recruiting
Led By J Todd Arnedt, Ph.D.
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing two therapies to help manage insomnia for people in treatment for alcohol use disorder, which can impact sleep quality and daytime functioning.

Who is the study for?
This trial is for people with alcohol use disorder who have been sober for less than 12 weeks and also struggle with chronic insomnia. Participants need video chat access, can travel to Ann Arbor for sleep assessments, and are enrolling in an abstinence program. Those with bipolar, psychotic disorders, PTSD, pregnancy plans during the study or severe illnesses causing insomnia cannot join.
What is being tested?
The M-STAR Study is testing Cognitive Behavioral Therapy for Insomnia (CBTi) versus Sleep Hygiene Education (SHE) to see which better improves sleep and daytime functioning in individuals undergoing treatment for alcohol use disorder.
What are the potential side effects?
Since both interventions involve therapy without medication, side effects may be minimal but could include temporary increases in stress or anxiety as participants adjust to new sleep routines.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with bipolar, psychotic disorder, or PTSD.
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I have a serious illness like cancer or dementia causing my insomnia.
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I am not pregnant nor planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB)
Score from the insomnia severity index (ISI)
Secondary study objectives
Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sleep Hygiene Education (SHE)Experimental Treatment1 Intervention
SHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep.
Group II: Cognitive Behavioral Therapy for insomnia (CBTi)Experimental Treatment1 Intervention
CBTi is a non-medication therapy that includes cognitive and behavioral treatment components.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Hygiene Education (SHE)
2021
N/A
~280

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,855 Previous Clinical Trials
6,434,911 Total Patients Enrolled
10 Trials studying Alcoholism
7,371 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,620 Total Patients Enrolled
456 Trials studying Alcoholism
823,636 Patients Enrolled for Alcoholism
J Todd Arnedt, Ph.D.Principal InvestigatorUniversity of Michigan

Media Library

Cognitive Behavioral Therapy for insomnia (CBTi) Clinical Trial Eligibility Overview. Trial Name: NCT04457674 — N/A
Alcoholism Research Study Groups: Cognitive Behavioral Therapy for insomnia (CBTi), Sleep Hygiene Education (SHE)
Alcoholism Clinical Trial 2023: Cognitive Behavioral Therapy for insomnia (CBTi) Highlights & Side Effects. Trial Name: NCT04457674 — N/A
Cognitive Behavioral Therapy for insomnia (CBTi) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04457674 — N/A
~24 spots leftby Aug 2025
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