xml: <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/NCT05973955</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00008187</org_study_id>
      <nct_id>NCT05973955</nct_id>
    </id_info>
    <brief_title>Adapting CBT-I for Hazardous Alcohol Users</brief_title>
    <official_title>Addressing Hazardous and Harmful Alcohol Use Through an Adapted CBT Sleep Intervention</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Rochester</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Rochester</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this intervention development trial is to develop, refine, and test a&#xD;
        telephone-delivered, 4-session version of cognitive behavioral therapy for insomnia adapted&#xD;
        to hazardous alcohol users with co-occurring insomnia. The project will begin with a small,&#xD;
        open label pilot to refine the intervention and proceed to a small, randomized trial&#xD;
        comparing the intervention to a sleep and alcohol education control condition.&#xD;
  &#xD;
        The two main questions it aims to answer are whether the intervention is feasible to deliver&#xD;
        and whether its effects on alcohol use and insomnia severity are large enough to warrant&#xD;
        further work.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Drinking problems and sleep problems each cause significant loss at individual and societal&#xD;
        levels. Insomnia in particular is highly prevalent in patients with alcohol use disorder, is&#xD;
        prospectively associated with the development of alcohol use disorder and contributes to&#xD;
        poorer recovery prognosis following alcohol treatments. Insomnia, therefore, represents a&#xD;
        modifiable risk factor for negative outcomes associated with alcohol use along the full&#xD;
        continuum of alcohol use problems.&#xD;
  &#xD;
        Accordingly, the project proposes to improve sleep with an insomnia intervention (cognitive&#xD;
        behavioral therapy for insomnia) tailored to adults who meet widely accepted definitions for&#xD;
        hazardous alcohol use as well as diagnostic criteria for insomnia disorder. An iterative&#xD;
        approach to development, refinement, and preliminary examination of the utility of a&#xD;
        telephone-delivered, 4-session intervention will be used. A small (N = 10), open label pilot&#xD;
        to develop and refine procedures for administering the intervention is followed by a small&#xD;
        (N=60), randomized trial comparing the intervention to a sleep and alcohol education control&#xD;
        condition. A number of intervention and study design feasibility domains will be assessed in&#xD;
        preparation for designing a larger study. The investigators will also assess the effects of&#xD;
        the intervention on alcohol use, sleep and mood by measuring these outcomes at baseline,&#xD;
        post-treatment, and at 3- and 6-month follow up assessments.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2026</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Abstinence</measure>
      <time_frame>6 months following the baseline assessment</time_frame>
      <description>The percentage of days abstinent (PDA) as measured by the Timeline Followback (TLFB)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Drinks per Drinking Day</measure>
      <time_frame>6 months following the baseline assessment</time_frame>
      <description>The average number of drinks per drinking day (DDD) as measured by the Timeline Followback (TLFB)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Insomnia Severity</measure>
      <time_frame>6 months following the baseline assessment</time_frame>
      <description>The average total score on the Insomnia Severity Index (ISI)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Insomnia</condition>
    <condition>Harmful; Use, Alcohol</condition>
    <arm_group>
      <arm_group_label>Education Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>A combination of alcohol education and sleep hygiene education comprised of four telephone-based sessions delivered over six weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Insomnia Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cognitive-behavioral therapy for insomnia adapted to hazardous alcohol users comprised of four telephone-based sessions delivered over six weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Insomnia Treatment</intervention_name>
      <description>The Insomnia Treatment is a version of Cognitive Behavioral Therapy for Insomnia adapted to individuals with hazardous alcohol use. It consists of the standard features of this well-established insomnia treatment in addition to adaptations that focus on alcohol use behaviors and alcohol-related thoughts that may be sleep-interfering as well as the provision of alcohol education material.</description>
      <arm_group_label>Insomnia Treatment</arm_group_label>
      <other_name>CBTi-HAU</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Education Control</intervention_name>
      <description>The Education Control intervention is an educational control that provides psychoeducation related to both sleep and to alcohol use.</description>
      <arm_group_label>Education Control</arm_group_label>
      <other_name>Alcohol &amp; Sleep Education</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  comprehension of written and spoken English (because we are developing and testing a&#xD;
               new intervention for which translated materials are not available);&#xD;
  &#xD;
            -  living in Monroe County, NY which includes and surrounds the city of Rochester or&#xD;
               adjacent surrounding Counties (self-report);&#xD;
  &#xD;
            -  Alcohol Use Disorder Identification Test (AUDIT) score of 8-15 to identify alcohol use&#xD;
               that is in the hazardous zone;&#xD;
  &#xD;
            -  current alcohol use (past 30 days) in excess of low-risk drinking guidelines as&#xD;
               defined by U.S. Department of Health and Human Services and U.S. Department of&#xD;
               Agriculture's 2015-2020 Dietary Guidelines for Americans using four items: items are&#xD;
               1) any use of alcohol; 2) the number of days that alcohol was used; 3) on days of&#xD;
               alcohol use, the usual number of drinks; 4) number of days with 4/5 or more drinks on&#xD;
               the same &quot;occasion&quot; defined as &quot;at the same time or within a couple hours of each&#xD;
               other&quot;. Based on these responses, we will determine if the individual exceeds low-risk&#xD;
               drinking guidelines;&#xD;
  &#xD;
            -  Insomnia Severity Index (ISI) score &gt; 8; and&#xD;
  &#xD;
            -  meet Diagnostic and Statistical Manual of Mental Disorders (5th edition; [DSM 5])&#xD;
               criteria for Insomnia Disorder (this is evaluated by answers on the ISI supplemented&#xD;
               by interview questions).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  having received Cognitive Behavioral Therapy for Insomnia (by self-report and&#xD;
               follow-up question prompts as needed);&#xD;
  &#xD;
            -  current or recent (past year) professional alcohol treatment (from self-report and&#xD;
               prompts), however, participants who only report beginning alcohol treatment during the&#xD;
               follow-up period will not be excluded from completing any remaining follow-up&#xD;
               assessments, but this will be recorded in the data and assessed as a potential&#xD;
               covariate.&#xD;
  &#xD;
            -  current or recent (past year) intravenous drug use or non-prescribed use of stimulant&#xD;
               medications (e.g., cocaine, methamphetamines) (from TLFB and self-report question&#xD;
               prompts);&#xD;
  &#xD;
            -  hospice patients, patients undergoing oncology treatment, patients with a recent or&#xD;
               upcoming surgery and/or endorsing a serious medical or psychiatric condition item from&#xD;
               a conditions and medications form administered by the Assessor);&#xD;
  &#xD;
            -  endorsing current suicidal ideation (past two weeks) with either a prior suicide&#xD;
               attempt or being assessed at higher risk for suicide by the &quot;P4 Screener&quot; (a suicide&#xD;
               risk screen used in both clinical settings and clinical trials);&#xD;
  &#xD;
            -  current pregnancy or intent to become pregnant during the next 6 months or given birth&#xD;
               in the past 3 months or currently breast-feeding;&#xD;
  &#xD;
            -  significant sleep disorders other than insomnia such as narcolepsy or untreated sleep&#xD;
               apnea with a Body Mass Index &gt; 32 (from self-report and the validated Sleep Disorders&#xD;
               Questionnaire screening instrument) although those receiving care for sleep apnea,&#xD;
               however, (e.g., positive airway pressure therapy) will be eligible; and&#xD;
  &#xD;
            -  providing false information such as false name, contact information, or study&#xD;
               responses.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wilfred R Pigeon, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Rochester</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wilfred R Pigeon, PhD</last_name>
      <phone>(585) 275-3374</phone>
      <email>wilfred_pigeon@urmc.rochester.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Rochester Medical Center</name>
        <address>
          <city>Rochester</city>
          <state>New York</state>
          <zip>14642</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Wilfred Pigeon, Ph.D.</last_name>
        <phone>585-275-3374</phone>
        <email>wilfred_pigeon@urmc.rochester.edu</email>
      </contact>
      <investigator>
        <last_name>Kenneth Conner, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Todd Bishop, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Beau Abar, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Rochester</investigator_affiliation>
      <investigator_full_name>Wilfred Pigeon, PhD</investigator_full_name>
      <investigator_title>Professor of Psychiatry</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Deidentified data will be submitted to a data archive: the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Data Archive. The study will submit data to the National Data Archive (NDA) according to all requirements and expectations per NOT-AA-22-003.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Data to be uploaded approximately every 6 months once subject enrollment begins and will be available for as long as NDA guidelines stipulate.</ipd_time_frame>
      <ipd_access_criteria>To follow the criteria and guidelines as set forth by NDA.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973955
  org study id: STUDY00008187
  nct id: NCT05973955
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this intervention development trial is to develop, refine, and test a
        telephone-delivered, 4-session version of cognitive behavioral therapy for insomnia adapted
        to hazardous alcohol users with co-occurring insomnia. The project will begin with a small,
        open label pilot to refine the intervention and proceed to a small, randomized trial
        comparing the intervention to a sleep and alcohol education control condition.
  
        The two main questions it aims to answer are whether the intervention is feasible to deliver
        and whether its effects on alcohol use and insomnia severity are large enough to warrant
        further work.
  Drinking problems and sleep problems each cause significant loss at individual and societal
        levels. Insomnia in particular is highly prevalent in patients with alcohol use disorder, is
        prospectively associated with the development of alcohol use disorder and contributes to
        poorer recovery prognosis following alcohol treatments. Insomnia, therefore, represents a
        modifiable risk factor for negative outcomes associated with alcohol use along the full
        continuum of alcohol use problems.
  
        Accordingly, the project proposes to improve sleep with an insomnia intervention (cognitive
        behavioral therapy for insomnia) tailored to adults who meet widely accepted definitions for
        hazardous alcohol use as well as diagnostic criteria for insomnia disorder. An iterative
        approach to development, refinement, and preliminary examination of the utility of a
        telephone-delivered, 4-session intervention will be used. A small (N = 10), open label pilot
        to develop and refine procedures for administering the intervention is followed by a small
        (N=60), randomized trial comparing the intervention to a sleep and alcohol education control
        condition. A number of intervention and study design feasibility domains will be assessed in
        preparation for designing a larger study. The investigators will also assess the effects of
        the intervention on alcohol use, sleep and mood by measuring these outcomes at baseline,
        post-treatment, and at 3- and 6-month follow up assessments.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Abstinence
  time frame: 6 months following the baseline assessment
  description: The percentage of days abstinent (PDA) as measured by the Timeline Followback (TLFB)
  measure: Drinks per Drinking Day
  time frame: 6 months following the baseline assessment
  description: The average number of drinks per drinking day (DDD) as measured by the Timeline Followback (TLFB)
  measure: Insomnia Severity
  time frame: 6 months following the baseline assessment
  description: The average total score on the Insomnia Severity Index (ISI)
  arm group label: Education Control
  arm group type: Placebo Comparator
  description: A combination of alcohol education and sleep hygiene education comprised of four telephone-based sessions delivered over six weeks.
  arm group label: Insomnia Treatment
  arm group type: Experimental
  description: Cognitive-behavioral therapy for insomnia adapted to hazardous alcohol users comprised of four telephone-based sessions delivered over six weeks.
  intervention type: Behavioral
  intervention name: Insomnia Treatment
  description: The Insomnia Treatment is a version of Cognitive Behavioral Therapy for Insomnia adapted to individuals with hazardous alcohol use. It consists of the standard features of this well-established insomnia treatment in addition to adaptations that focus on alcohol use behaviors and alcohol-related thoughts that may be sleep-interfering as well as the provision of alcohol education material.
  arm group label: Insomnia Treatment
  other name: CBTi-HAU
  intervention type: Behavioral
  intervention name: Education Control
  description: The Education Control intervention is an educational control that provides psychoeducation related to both sleep and to alcohol use.
  arm group label: Education Control
  other name: Alcohol & Sleep Education
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Wilfred R Pigeon, PhD
  role: Principal Investigator
  affiliation: University of Rochester
  last name: Wilfred R Pigeon, PhD
  phone: (585) 275-3374
  email: wilfred_pigeon@urmc.rochester.edu
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Rochester
  investigator full name: Wilfred Pigeon, PhD
  investigator title: Professor of Psychiatry
  sharing ipd: Yes
  ipd description: Deidentified data will be submitted to a data archive: the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Data Archive. The study will submit data to the National Data Archive (NDA) according to all requirements and expectations per NOT-AA-22-003.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Data to be uploaded approximately every 6 months once subject enrollment begins and will be available for as long as NDA guidelines stipulate.
  ipd access criteria: To follow the criteria and guidelines as set forth by NDA.