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

Primary Purpose

Insomnia, Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for insomnia (CBTi)
Sleep Hygiene Education (SHE)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Cognitive Behavioral Therapy, Sleep Hygiene

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Cognitive Behavioral Therapy for insomnia (CBTi)

Sleep Hygiene Education (SHE)

Arm Description

CBTi is a non-medication therapy that includes cognitive and behavioral treatment components.

SHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale
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.

Full Information

First Posted
June 29, 2020
Last Updated
January 25, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04457674
Brief Title
Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)
Official Title
Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2020 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Alcohol Use Disorder
Keywords
Cognitive Behavioral Therapy, Sleep Hygiene

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy for insomnia (CBTi)
Arm Type
Other
Arm Description
CBTi is a non-medication therapy that includes cognitive and behavioral treatment components.
Arm Title
Sleep Hygiene Education (SHE)
Arm Type
Other
Arm Description
SHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for insomnia (CBTi)
Intervention Description
CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene Education (SHE)
Intervention Description
SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
Primary Outcome Measure Information:
Title
Score from the insomnia severity index (ISI)
Description
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.
Time Frame
Immediately post treatment
Title
Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB)
Description
The Alcohol TLFB is an interviewer-based drinking assessment method to estimate drinking behaviors, including both frequency and quantity of consumption.
Time Frame
Immediately post treatment
Secondary Outcome Measure Information:
Title
Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale
Description
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.
Time Frame
Immediately post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mandilyn Graham
Phone
734-232-0276
Email
grmandil@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Todd Arnedt, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandilyn Graham
Phone
734-232-0276
Email
grmandil@umich.edu
First Name & Middle Initial & Last Name & Degree
J Todd Arnedt, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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