<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/NCT03002402</url>
  </required_header>
  <id_info>
    <org_study_id>1R03HL135213-01</org_study_id>
    <secondary_id>1R03HL135213-01</secondary_id>
    <nct_id>NCT03002402</nct_id>
  </id_info>
  <brief_title>Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma</brief_title>
  <official_title>Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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 purpose of the proposed study are to explore changes in sleep and asthma outcomes from&#xD;
      baseline to post-treatment in adults with asthma and comorbid insomnia who underwent&#xD;
      Internet-based cognitive-behavioral treatment for insomnia (CBT-I).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">July 17, 2017</completion_date>
  <primary_completion_date type="Actual">July 17, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia severity</measure>
    <time_frame>baseline and post-intervention (up to 9 weeks)</time_frame>
    <description>Insomnia Severity Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Asthma control</measure>
    <time_frame>baseline and post-intervention (up to 9 weeks)</time_frame>
    <description>Asthma Control Test</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Asthma</condition>
  <condition>Insomnia Chronic</condition>
  <arm_group>
    <arm_group_label>Internet-based CBT-I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sleep Healthy Using the Internet (SHUTi) is a self-guided, automated, interactive, and tailored web-based program modeled on the primary tenets of cognitive-behavioral treatment for insomnia (CBT-I): sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. Intervention content is allocated out over time through 6 &quot;Cores.&quot; Users obtain access to a new Core based on a time and event-based schedule (e.g., 7 days after completion of previous Core). SHUTi uses online sleep diaries to track progress and to tailor treatment (e.g., assign a sleep restriction window).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet-based CBT-I</intervention_name>
    <description>Internet-based cognitive-behavioral treatment for insomnia</description>
    <arm_group_label>Internet-based CBT-I</arm_group_label>
    <other_name>Sleep Healthy Using the Internet (SHUTi)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary diagnosis of moderate-severe persistent asthma&#xD;
&#xD;
          -  Not well controlled asthma (score ≤ 19 on the Asthma Control Test)&#xD;
&#xD;
          -  Age 18-75 years&#xD;
&#xD;
          -  Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM-5)&#xD;
             Insomnia Disorder&#xD;
&#xD;
          -  At least moderate insomnia severity (score ≥ 10 on Insomnia Severity Index)&#xD;
&#xD;
          -  Telephone number, email address, and reliable Internet access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of bipolar or psychosis&#xD;
&#xD;
          -  Substance abuse disorder within past 3 months&#xD;
&#xD;
          -  Dementia or probable dementia diagnosis&#xD;
&#xD;
          -  Plans to move or leave present source of care during the following 6 months.&#xD;
&#xD;
          -  Non-English speaking, illiterate, or possesses sensory deficits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faith S Luyster, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Faith Luyster</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>insomnia</keyword>
  <keyword>cognitive-behavioral treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03002402
org study id: 1R03HL135213-01
secondary id: 1R03HL135213-01
nct id: NCT03002402
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the proposed study are to explore changes in sleep and asthma outcomes from
      baseline to post-treatment in adults with asthma and comorbid insomnia who underwent
      Internet-based cognitive-behavioral treatment for insomnia (CBT-I).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Insomnia severity
time frame: baseline and post-intervention (up to 9 weeks)
description: Insomnia Severity Index
measure: Asthma control
time frame: baseline and post-intervention (up to 9 weeks)
description: Asthma Control Test
arm group label: Internet-based CBT-I
arm group type: Experimental
description: Sleep Healthy Using the Internet (SHUTi) is a self-guided, automated, interactive, and tailored web-based program modeled on the primary tenets of cognitive-behavioral treatment for insomnia (CBT-I): sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. Intervention content is allocated out over time through 6 "Cores." Users obtain access to a new Core based on a time and event-based schedule (e.g., 7 days after completion of previous Core). SHUTi uses online sleep diaries to track progress and to tailor treatment (e.g., assign a sleep restriction window).
intervention type: Behavioral
intervention name: Internet-based CBT-I
description: Internet-based cognitive-behavioral treatment for insomnia
arm group label: Internet-based CBT-I
other name: Sleep Healthy Using the Internet (SHUTi)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Faith S Luyster, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Faith Luyster
investigator title: Assistant Professor
mesh term: Asthma
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No