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

March 19, 2024 updated by: J. Todd Arnedt, University of Michigan

Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • The University of Michigan
        • Contact:
        • Principal Investigator:
          • J Todd Arnedt, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score from the insomnia severity index (ISI)
Time Frame: 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.
Immediately post treatment
Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB)
Time Frame: Immediately post treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale
Time Frame: 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.
Immediately post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: J Todd Arnedt, Ph.D., University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2020

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

July 2, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00173631
  • R01AA028158 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The data will be available following data collection and for 1-2 years following the end of the study grant.

IPD Sharing Access Criteria

Data shared via the NIMH database is accessible by those associated with NIH institutions who have also signed data sharing agreements.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insomnia

Clinical Trials on Cognitive Behavioral Therapy for insomnia (CBTi)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe