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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
1,786 Previous Clinical Trials
6,365,372 Total Patients Enrolled
9 Trials studying Alcoholism
7,311 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
796 Previous Clinical Trials
1,361,273 Total Patients Enrolled
420 Trials studying Alcoholism
984,795 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being welcomed to join this clinical trial?

"Absolutely. According to the information on clinicaltrials.gov, this medical investigation is actively recruiting patients; it was first posted on November 7th 2020 and recently modified September 26 2022. A total of 150 volunteers must be recruited from one location for the study's completion."

Answered by AI

Are participants currently being enrolled for this experiment?

"Clinicaltrials.gov reports that this trial is actively seeking new participants, with the initial posting of 11/7/2020 and the most recent update on 9/26/2022."

Answered by AI

Who is eligible to join this clinical trial?

"To qualify for participation in this study, applicants need to be diagnosed with an alcohol use disorder and between 18-65 years old. Approximately 150 people will be enlisted into the trial."

Answered by AI

Is the age cap for this trial set at 85 years old?

"This clinical trial has pre-defined age restrictions; those hoping to participate must be 18 years of age or older, yet no more than 65."

Answered by AI
~17 spots leftby Aug 2024