<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04457674</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00173631</org_study_id>
    <secondary_id>R01AA028158</secondary_id>
    <nct_id>NCT04457674</nct_id>
  </id_info>
  <brief_title>Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)</brief_title>
  <official_title>Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Insomnia is common in people who are in treatment for alcohol use disorder. It can impact&#xD;
      both sleep quality and daytime functioning, as well as make it harder to treat the underlying&#xD;
      alcohol use disorder. This study is looking at two types of therapy to help manage insomnia&#xD;
      specifically for people also in treatment for alcohol use disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 7, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score from the insomnia severity index (ISI)</measure>
    <time_frame>Immediately post treatment</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB)</measure>
    <time_frame>Immediately post treatment</time_frame>
    <description>The Alcohol TLFB is an interviewer-based drinking assessment method to estimate drinking behaviors, including both frequency and quantity of consumption.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale</measure>
    <time_frame>Immediately post treatment</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Insomnia</condition>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy for insomnia (CBTi)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>CBTi is a non-medication therapy that includes cognitive and behavioral treatment components.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep Hygiene Education (SHE)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>SHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy for insomnia (CBTi)</intervention_name>
    <description>CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.</description>
    <arm_group_label>Cognitive Behavioral Therapy for insomnia (CBTi)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Hygiene Education (SHE)</intervention_name>
    <description>SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.</description>
    <arm_group_label>Sleep Hygiene Education (SHE)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet probable Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria&#xD;
             for Alcohol Use Disorder with ≤12 weeks of abstinence&#xD;
&#xD;
          -  Planned enrollment into an abstinence-based treatment program&#xD;
&#xD;
          -  Meet probable DSM-5 criteria for chronic insomnia, confirmed with sleep diary&#xD;
&#xD;
          -  Ability to travel to Ann Arbor for sleep laboratory assessments&#xD;
&#xD;
          -  Access to a video chat-capable device and reliable Wi-Fi network&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of, or high suspicion for, sleep disorders other than insomnia&#xD;
&#xD;
          -  Meet probable DSM-5 criteria for bipolar disorder, psychotic disorder, or&#xD;
             post-traumatic stress disorder (PTSD)&#xD;
&#xD;
          -  Terminal or progressive physical illness (e.g., cancer), neurological degenerative&#xD;
             disease (e.g., dementia), or presence of an unstable medical condition that is the&#xD;
             specific cause of insomnia&#xD;
&#xD;
          -  Self-reported pregnancy or intention to become pregnant during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J Todd Arnedt, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mandilyn Graham</last_name>
    <phone>734-232-0276</phone>
    <email>grmandil@umich.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>The University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mandilyn Graham</last_name>
      <phone>734-232-0276</phone>
      <email>grmandil@umich.edu</email>
    </contact>
    <investigator>
      <last_name>J Todd Arnedt, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>J. Todd Arnedt</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <keyword>Sleep Hygiene</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>The data will be available following data collection and for 1-2 years following the end of the study grant.</ipd_time_frame>
    <ipd_access_criteria>Data shared via the NIMH database is accessible by those associated with NIH institutions who have also signed data sharing agreements.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 15, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT04457674/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04457674
org study id: HUM00173631
secondary id: R01AA028158
nct id: NCT04457674
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Score from the insomnia severity index (ISI)
time frame: Immediately post treatment
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.
measure: Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB)
time frame: Immediately post treatment
description: The Alcohol TLFB is an interviewer-based drinking assessment method to estimate drinking behaviors, including both frequency and quantity of consumption.
measure: Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale
time frame: Immediately post treatment
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.
arm group label: Cognitive Behavioral Therapy for insomnia (CBTi)
arm group type: Other
description: CBTi is a non-medication therapy that includes cognitive and behavioral treatment components.
arm group label: Sleep Hygiene Education (SHE)
arm group type: Other
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: Cognitive Behavioral Therapy for insomnia (CBTi)
description: CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
arm group label: Cognitive Behavioral Therapy for insomnia (CBTi)
intervention type: Behavioral
intervention name: Sleep Hygiene Education (SHE)
description: SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
arm group label: Sleep Hygiene Education (SHE)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: J Todd Arnedt, Ph.D.
role: Principal Investigator
affiliation: University of Michigan
last name: Mandilyn Graham
phone: 734-232-0276
email: grmandil@umich.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: J. Todd Arnedt
investigator title: Associate Professor of Psychiatry
mesh term: Alcoholism
mesh term: Alcohol Drinking
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: The data will be available following data collection and for 1-2 years following the end of the study grant.
ipd access criteria: Data shared via the NIMH database is accessible by those associated with NIH institutions who have also signed data sharing agreements.
provided document: 