<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/NCT02259101</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00065796</org_study_id>
    <nct_id>NCT02259101</nct_id>
  </id_info>
  <brief_title>RCT of CBT for Insomnia With PLWHA</brief_title>
  <official_title>A Randomized Controlled Trial of Cognitive Behavior Therapy for Insomnia With Persons Living With HIV/AIDS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will consist of a randomized controlled trial (RCT) comparing a known&#xD;
      efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to test whether a group cognitive-behavioral treatment program&#xD;
      for insomnia (CBT-I) will help adults diagnosed with HIV to improve the quantity (number of&#xD;
      hours) and the quality of their sleep. The PI will compare adults who participated in the&#xD;
      CBT-I program to adults who participated in a Sleep Hygiene group, a common treatment for&#xD;
      insomnia. The PI will look at the overall quality of life, and number of hours and quality of&#xD;
      sleep of adults who participated in the CBT-I program versus adults in the Sleep Hygiene&#xD;
      group. Also, the PI will draw blood to compare how the body responds to medical illnesses&#xD;
      between adults in the CBT-I program to adults in the Sleep Hygiene group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia Symptoms</measure>
    <time_frame>baseline, up to 5 weeks post-intervention</time_frame>
    <description>Compare insomnia scores on the Insomnia Severity Index (questionnaire) between the CBT-I treatment condition vs. SH comparison condition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>baseline, up to 5 weeks post-intervention</time_frame>
    <description>Compare quality of life scores on the HIV/AIDS Targeted-Quality of Life (scale) between CBT-I treatment condition vs. SH comparison condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Sample</measure>
    <time_frame>baseline, up to 5 weeks post-intervention</time_frame>
    <description>Evaluate and compare markers of inflammation between participants in the CBT-I treatment condition vs. SH comparison condition.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Insomnia</condition>
  <condition>HIV</condition>
  <condition>Aids</condition>
  <arm_group>
    <arm_group_label>CBT-I Treatment Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The CBT-I treatment condition will be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks. Four total CBT-I groups occurring over the course of two years will be implemented, with at total of 40 participants enrolled for the CBT-I condition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SH Comparison Condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The SH comparison condition will also be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks. Four total SH groups over the course of two years will be conducted, with a total of 40 participants enrolled for the SH condition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT-I Treatment Condition</intervention_name>
    <description>Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.</description>
    <arm_group_label>CBT-I Treatment Condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SH Comparison Condition</intervention_name>
    <description>Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.</description>
    <arm_group_label>SH Comparison Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking individuals&#xD;
&#xD;
          -  over the age of 18 years old with a diagnosis of HIV or AIDS who is receiving medical&#xD;
             care at the Grady Health System's Infectious Disease Program (IDP)&#xD;
&#xD;
          -  study subjects must meet the criteria for primary or secondary insomnia as defined by&#xD;
             the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision&#xD;
&#xD;
          -  must experience difficulty initiating or maintaining non-restorative sleep for at&#xD;
             least l month (DSM- IV-TR)&#xD;
&#xD;
          -  the sleep disturbance causes clinically significant impairment or distress in&#xD;
             important areas of functioning&#xD;
&#xD;
          -  sleep efficiency of less than 85%, sleep disturbances that occur three or more days&#xD;
             per week, and sleep latency (i.e., time awake after sleep onset greater than 30&#xD;
             minutes)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current substance dependence (within the past six months)&#xD;
&#xD;
          -  active psychosis&#xD;
&#xD;
          -  Bipolar I and II disorders&#xD;
&#xD;
          -  neurocognitive impairment and/or a current diagnosis of dementia&#xD;
&#xD;
          -  lack of independent housing&#xD;
&#xD;
          -  previous participation in a CBT-I program&#xD;
&#xD;
          -  employment in a job requiring shift work that impairs the ability to establish a&#xD;
             regular sleep schedule&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amit Shahane, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grady Memorial Hospital/Infectious Disease Program</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>May 5, 2016</last_update_submitted>
  <last_update_submitted_qc>May 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Amit Shahane</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02259101
org study id: IRB00065796
nct id: NCT02259101
lead sponsor: 
has dmc: No
The proposed study will consist of a randomized controlled trial (RCT) comparing a known
      efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.
The purpose of this study is to test whether a group cognitive-behavioral treatment program
      for insomnia (CBT-I) will help adults diagnosed with HIV to improve the quantity (number of
      hours) and the quality of their sleep. The PI will compare adults who participated in the
      CBT-I program to adults who participated in a Sleep Hygiene group, a common treatment for
      insomnia. The PI will look at the overall quality of life, and number of hours and quality of
      sleep of adults who participated in the CBT-I program versus adults in the Sleep Hygiene
      group. Also, the PI will draw blood to compare how the body responds to medical illnesses
      between adults in the CBT-I program to adults in the Sleep Hygiene group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Insomnia Symptoms
time frame: baseline, up to 5 weeks post-intervention
description: Compare insomnia scores on the Insomnia Severity Index (questionnaire) between the CBT-I treatment condition vs. SH comparison condition.
measure: Quality of Life
time frame: baseline, up to 5 weeks post-intervention
description: Compare quality of life scores on the HIV/AIDS Targeted-Quality of Life (scale) between CBT-I treatment condition vs. SH comparison condition.
measure: Blood Sample
time frame: baseline, up to 5 weeks post-intervention
description: Evaluate and compare markers of inflammation between participants in the CBT-I treatment condition vs. SH comparison condition.
arm group label: CBT-I Treatment Condition
arm group type: Experimental
description: The CBT-I treatment condition will be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks. Four total CBT-I groups occurring over the course of two years will be implemented, with at total of 40 participants enrolled for the CBT-I condition.
arm group label: SH Comparison Condition
arm group type: Active Comparator
description: The SH comparison condition will also be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks. Four total SH groups over the course of two years will be conducted, with a total of 40 participants enrolled for the SH condition.
intervention type: Behavioral
intervention name: CBT-I Treatment Condition
description: Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.
arm group label: CBT-I Treatment Condition
intervention type: Behavioral
intervention name: SH Comparison Condition
description: Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.
arm group label: SH Comparison Condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amit Shahane, Ph.D.
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Amit Shahane
investigator title: Assistant Professor
mesh term: Sleep Initiation and Maintenance Disorders