<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/NCT03305354</url>
  </required_header>
  <id_info>
    <org_study_id>17-09-10</org_study_id>
    <nct_id>NCT03305354</nct_id>
  </id_info>
  <brief_title>Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia</brief_title>
  <official_title>Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia: Does Enhancing Physical Activity Help?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northeastern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Edith Nourse Rogers Memorial Veterans Hospital</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Northeastern University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Veterans of the most recent wars in Afghanistan and Iraq (collectively, post 9/11 Veterans)&#xD;
      have notable sleep problems including chronic insomnia. Here, the investigators plan to&#xD;
      compare two groups of veterans with insomnia: (1) one group that completes a 6 week&#xD;
      self-management-guided use of a mobile app based on cognitive behavioral therapy for insomnia&#xD;
      (CBTI alone) and (2) one group that completes a 6 week combined self-management-guided use of&#xD;
      the mobile CBTI app in addition to a physical activity (PA) intervention (CBTI + PA). The&#xD;
      investigators hypothesize that the group receiving the adjunctive 6-week PA intervention will&#xD;
      have better subjective and objective sleep, higher step counts, and better functional health&#xD;
      and social and community integration than those receiving CBTI alone. This pilot work will&#xD;
      provide evidence to guide the design of a future randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine if the addition of physical activity (PA) to (CBTI) can further enhance sleep,&#xD;
      physical activity, functioning, or social engagement over and above self-management use of a&#xD;
      CBTI app alone, the investigators will randomly assign post-9/11 veteran participants with&#xD;
      chronic, functionally impairing insomnia to either (1) a self-management-based use of an app&#xD;
      based on cognitive behavioral therapy for insomnia (CBTI; CBTI alone arm) or to (2) a&#xD;
      self-management-based use of the CBTI app + a physical activity (PA) intervention (CBTI + PA)&#xD;
      that includes PA monitoring (via a Fitbit device) with individualized goal-setting to&#xD;
      encourage increased daily steps across the 6 weeks. For the PA goal, the investigators will&#xD;
      attempt to get all participants to at least the typical 10,000 daily steps goal cited as a&#xD;
      strong predictor of positive health outcomes (Choi, Pak, &amp; Choi, 2007). The investigators&#xD;
      will tailor the step goals based on the person's initial level of daily steps, and increment&#xD;
      step goals weekly to maximize motivation and enhance the likelihood that the participant can&#xD;
      meet the goal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2018</start_date>
  <completion_date type="Actual">June 27, 2019</completion_date>
  <primary_completion_date type="Actual">June 27, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia Severity Index Total Score</measure>
    <time_frame>6 weeks (Immediate post-intervention)</time_frame>
    <description>Total score on the Insomnia Severity Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pittsburgh Sleep Quality Index Total Score</measure>
    <time_frame>6 weeks (Immediate post-intervention)</time_frame>
    <description>Total score on the Pittsburgh Sleep Quality Index Total Score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Sleep Efficiency</measure>
    <time_frame>6 weeks (Immediate post-intervention)</time_frame>
    <description>Time spent in bed divided by time spent asleep as measured by the WatchPAT sleep monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily step counts</measure>
    <time_frame>6 weeks (Immediate post-intervention)</time_frame>
    <description>Daily step counts as measured by a Fitbit device</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Functional Outcomes of Sleep</measure>
    <time_frame>6 weeks (Immediate post-intervention)</time_frame>
    <description>Functional Outcomes of Sleep Questionnaire total score (10 item version)</description>
  </other_outcome>
  <other_outcome>
    <measure>Social Engagement</measure>
    <time_frame>6 weeks (Immediate post-intervention)</time_frame>
    <description>Total score on the Lubben Social Network Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Community Engagement</measure>
    <time_frame>6 weeks (Immediate post-intervention)</time_frame>
    <description>Total score on the Community Integration Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical Functional Health</measure>
    <time_frame>6 weeks (Immediate post-intervention)</time_frame>
    <description>Physical Function score from the Veteran's RAND-12 scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Mental Functional Health</measure>
    <time_frame>6 weeks (Immediate post-intervention)</time_frame>
    <description>Mental Function score from the Veteran's RAND-12 scale</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Chronic Insomnia</condition>
  <arm_group>
    <arm_group_label>CBTI app intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBTI app+Physical Activity Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide plus self-management guidance on increased step counts</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBTI app intervention</intervention_name>
    <description>Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep</description>
    <arm_group_label>CBTI app intervention</arm_group_label>
    <arm_group_label>CBTI app+Physical Activity Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Activity intervention</intervention_name>
    <description>Self-management guided motivation to increase physical activity by increasing daily step counts</description>
    <arm_group_label>CBTI app+Physical Activity Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible individuals will be US military Veterans&#xD;
&#xD;
          -  Eligible veterans will have served in the military during the post-9/11 period&#xD;
&#xD;
          -  Eligible veterans will have chronic, functionally impairing insomnia (i.e., at&#xD;
             baseline veterans must have an Insomnia Severity Index score &gt; 10 with insomnia&#xD;
             duration of at least 1 month, and impaired daytime functioning.&#xD;
&#xD;
          -  Eligible individuals must be willing to use devices (e.g., Fitbit, WatchPAT)provided&#xD;
             by the study team.&#xD;
&#xD;
          -  Eligible individuals may have mild or moderate obstructive sleep apnea (as determined&#xD;
             by one out of either of two nights with a WatchPAT-based Apnea-Hypopnea Index [AHI] &lt;=&#xD;
             30 events/hour of sleep).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Periodic leg movements&#xD;
&#xD;
          -  Circadian rhythm disorder&#xD;
&#xD;
          -  Use of medications or health issues (e.g., permanent pacemaker, sustained non-sinus&#xD;
             cardiac arrhythmias, finger deformity, etc.) that would interfere with the use of the&#xD;
             WatchPAT sleep monitor&#xD;
&#xD;
          -  Severe obstructive sleep apnea (as determined by one out of either of two nights with&#xD;
             a WatchPAT-based Apnea-Hypopnea Index [AHI] &gt; 30 events/hour of sleep)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen S Quigley, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northeastern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Edith Nourse Rogers Memorial VA Hospital</name>
      <address>
        <city>Bedford</city>
        <state>Massachusetts</state>
        <zip>01730</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>August 19, 2019</last_update_submitted>
  <last_update_submitted_qc>August 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northeastern University</investigator_affiliation>
    <investigator_full_name>Karen Quigley</investigator_full_name>
    <investigator_title>Research Associate Professor</investigator_title>
  </responsible_party>
  <keyword>mobile health</keyword>
  <keyword>physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03305354
org study id: 17-09-10
nct id: NCT03305354
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Veterans of the most recent wars in Afghanistan and Iraq (collectively, post 9/11 Veterans)
      have notable sleep problems including chronic insomnia. Here, the investigators plan to
      compare two groups of veterans with insomnia: (1) one group that completes a 6 week
      self-management-guided use of a mobile app based on cognitive behavioral therapy for insomnia
      (CBTI alone) and (2) one group that completes a 6 week combined self-management-guided use of
      the mobile CBTI app in addition to a physical activity (PA) intervention (CBTI + PA). The
      investigators hypothesize that the group receiving the adjunctive 6-week PA intervention will
      have better subjective and objective sleep, higher step counts, and better functional health
      and social and community integration than those receiving CBTI alone. This pilot work will
      provide evidence to guide the design of a future randomized controlled trial.
To determine if the addition of physical activity (PA) to (CBTI) can further enhance sleep,
      physical activity, functioning, or social engagement over and above self-management use of a
      CBTI app alone, the investigators will randomly assign post-9/11 veteran participants with
      chronic, functionally impairing insomnia to either (1) a self-management-based use of an app
      based on cognitive behavioral therapy for insomnia (CBTI; CBTI alone arm) or to (2) a
      self-management-based use of the CBTI app + a physical activity (PA) intervention (CBTI + PA)
      that includes PA monitoring (via a Fitbit device) with individualized goal-setting to
      encourage increased daily steps across the 6 weeks. For the PA goal, the investigators will
      attempt to get all participants to at least the typical 10,000 daily steps goal cited as a
      strong predictor of positive health outcomes (Choi, Pak, & Choi, 2007). The investigators
      will tailor the step goals based on the person's initial level of daily steps, and increment
      step goals weekly to maximize motivation and enhance the likelihood that the participant can
      meet the goal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Insomnia Severity Index Total Score
time frame: 6 weeks (Immediate post-intervention)
description: Total score on the Insomnia Severity Index
measure: Pittsburgh Sleep Quality Index Total Score
time frame: 6 weeks (Immediate post-intervention)
description: Total score on the Pittsburgh Sleep Quality Index Total Score
measure: Objective Sleep Efficiency
time frame: 6 weeks (Immediate post-intervention)
description: Time spent in bed divided by time spent asleep as measured by the WatchPAT sleep monitor
measure: Daily step counts
time frame: 6 weeks (Immediate post-intervention)
description: Daily step counts as measured by a Fitbit device
measure: Functional Outcomes of Sleep
time frame: 6 weeks (Immediate post-intervention)
description: Functional Outcomes of Sleep Questionnaire total score (10 item version)
measure: Social Engagement
time frame: 6 weeks (Immediate post-intervention)
description: Total score on the Lubben Social Network Scale
measure: Community Engagement
time frame: 6 weeks (Immediate post-intervention)
description: Total score on the Community Integration Questionnaire
measure: Physical Functional Health
time frame: 6 weeks (Immediate post-intervention)
description: Physical Function score from the Veteran's RAND-12 scale
measure: Mental Functional Health
time frame: 6 weeks (Immediate post-intervention)
description: Mental Function score from the Veteran's RAND-12 scale
arm group label: CBTI app intervention
arm group type: Experimental
description: Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide
arm group label: CBTI app+Physical Activity Intervention
arm group type: Active Comparator
description: Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide plus self-management guidance on increased step counts
intervention type: Behavioral
intervention name: CBTI app intervention
description: Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep
arm group label: CBTI app intervention
arm group label: CBTI app+Physical Activity Intervention
intervention type: Behavioral
intervention name: Physical Activity intervention
description: Self-management guided motivation to increase physical activity by increasing daily step counts
arm group label: CBTI app+Physical Activity Intervention
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Karen S Quigley, PhD
role: Principal Investigator
affiliation: Northeastern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northeastern University
investigator full name: Karen Quigley
investigator title: Research Associate Professor
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No