<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/NCT03826849</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-47188</org_study_id>
    <nct_id>NCT03826849</nct_id>
  </id_info>
  <brief_title>A Pilot Evaluation of the Insomnia Coach Mobile App</brief_title>
  <official_title>A Pilot Evaluation of the Insomnia Coach Mobile App</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Palo Alto Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Palo Alto Health Care System</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>
      This pilot study is designed to test the feasibility, acceptability, and potential&#xD;
      effectiveness of a mobile phone application (app) developed by the VA National Center for&#xD;
      PTSD (VA NCPTSD) for use by Veterans with insomnia. The primary objective is to assess&#xD;
      whether Veterans find the Insomnia Coach app to be satisfactory and feasible to use.&#xD;
      Secondary objectives are to determine if use of the app improves subjective sleep quality and&#xD;
      sleep parameters (e.g., sleep latency, wake after sleep onset, and total sleep time), as well&#xD;
      as other important outcomes (e.g., daily functioning).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are high rates of insomnia among Veterans, particularly those who have been exposed to&#xD;
      potentially traumatic situations (i.e., combat exposure) and few receive cognitive-behavioral&#xD;
      therapy for insomnia (CBT-I), a first-line treatment for insomnia. Insomnia Coach is a mobile&#xD;
      app for individuals with insomnia symptoms. This app provides:&#xD;
&#xD;
        -  education about sleep, the development of insomnia, and evidence based behavioral and&#xD;
           cognitive strategies&#xD;
&#xD;
        -  self-assessment tools measuring insomnia severity and sleep need&#xD;
&#xD;
        -  self-monitoring with a daily sleep diary&#xD;
&#xD;
        -  self-management tools for relaxation and changing thinking about sleep&#xD;
&#xD;
        -  individualized recommendations for a preferable sleep window (i.e., bed and rise times)&#xD;
&#xD;
        -  daily reminders for behavioral changes In this pilot randomized controlled trial (RCT),&#xD;
           50 Veterans with significant insomnia symptoms will be recruited using flyers and social&#xD;
           media (i.e., Facebook ads) and randomized in equal numbers to receive one of two&#xD;
           conditions: 1) the Insomnia Coach mobile app (which is based on cognitive-behavioral&#xD;
           therapy for insomnia (CBT-I)) and, 2) a waitlist control.&#xD;
&#xD;
      Objective use of the Insomnia Coach mobile app will be tracked to assess feasibility (i.e.,&#xD;
      will participants use the app as intended). Participants will complete measures (using&#xD;
      Qualtrics) of sleep, insomnia severity, depression and anxiety, and functional well-being at&#xD;
      baseline, 6 weeks (posttreatment), and 12 weeks (follow-up). At post-treatment, participants&#xD;
      in the Insomnia Coach app condition will also be asked to report their level of satisfaction&#xD;
      with the app and to complete a brief qualitative evaluation of their experience using the&#xD;
      app. Waitlist control condition participants will be informed about the Insomnia Coach app&#xD;
      and provided with information on how to download it after completion of the follow-up&#xD;
      assessment (i.e., at 12 weeks).&#xD;
&#xD;
      The aim of this research is to learn whether individuals, particularly Veterans, with&#xD;
      insomnia, find Insomnia Coach to be satisfactory and feasible to use. It also aims to assess&#xD;
      if use of the app potentially improves subjective sleep quality and sleep parameters (e.g.,&#xD;
      sleep latency, wake after sleep onset, and total sleep time), as well as other important&#xD;
      outcomes (e.g., daily functioning). If this research demonstrates that Insomnia Coach is a&#xD;
      promising tool for individuals experiencing sleep difficulties, it has the potential to&#xD;
      address a need using a very cost-effective, widely accessible, scalable solution that would&#xD;
      warrant more rigorous evaluation (e.g., a full-scale RCT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>Objective App Usage Data</measure>
    <time_frame>6 weeks</time_frame>
    <description>Composite of app usage data comprised of button taps, sections visited, self-entered data, number of visits and days used, and time spent on the app per visit. Various combinations and aggregations of these behaviors will be explored as best indicators to optimally summarize app use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mobile Apps Rating Scale (MARS; Stoyanov et al., 2015)</measure>
    <time_frame>6 weeks</time_frame>
    <description>A 20-item multidimensional, objective measure of app usability. It includes four subscales that measure an app's engagement, functionality, aesthetics, and information quality. All items are rated on a 5-point scale from &quot;1. Inadequate&quot; to &quot;5. Excellent&quot;. The scores are tallied up and a mean score out of 5 is given to each of the categories scored.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>System Usability Scale (SUS; Brooke, 1986)</measure>
    <time_frame>6 weeks</time_frame>
    <description>A 10-item questionnaire of usability of products and services, including hardware, software, mobile devices, websites and applications. Items are on a 5-point scale numbered 1 to 5. Half of the items are worded negatively and half are worded positively. SUS yields a single number representing a composite measure of the overall usability of the system. To calculate the SUS score, the score contributions from each item are summed. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Then the sum of the scores is multiplied by 2.5 to obtain the overall value of SU. SUS scores have a range of 0 to 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative Interview (Kuhn &amp; Miller, 2018)</measure>
    <time_frame>6 weeks</time_frame>
    <description>A 24-question, semi-structured interview to assess users' perceptions of Insomnia Coach.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index (ISI; Bastien et al., 2011)</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>A 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia symptoms in the past month. Items are on a scale from 0 to 4. The seven answers are added up to get a total score, with higher scores reflecting greater insomnia severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>A 19-item self-report measure assessing qualities and problems associated with sleep in the past month. It generates seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. A global sleep quality score is obtained by summing the seven component scores. Higher scores reflect poorer sleep quality. The global score ranges from 0 to 21, with a cut-off score of 5 as distinguishing &quot;good&quot; sleepers from &quot;poor&quot; sleepers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS-Sleep-Related Impairment (PROMIS-SRI; Buysse et al., 2010)</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>This 16-item self-report form assesses sleep-related impairment over the past seven days. Each question has five response options ranging in value from 1 to 5. To find the total raw score the values of the response to each question are summed. The raw scores are converted to a standardized T-score using conversion tables published on the PROMIS website (nihpromis.org), with higher scores indicating greater sleep/wake disturbances.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consensus Sleep Diary: Change in sleep onset latency (Carney et al., 2012)</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>The Consensus Sleep Diary will be used to prospectively monitor self-reported sleep. Shorter sleep onset indicates faster time to fall asleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consensus Sleep Diary: Change in wake after sleep onset (Carney et al., 2012)</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>The Consensus Sleep Diary will be used to prospectively monitor self-reported sleep. Less time spent awake during the sleep period indicates better sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consensus Sleep Diary: Change in sleep efficiency (Carney et al., 2012)</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>The Consensus Sleep Diary will be used to prospectively monitor self-reported sleep. Higher sleep efficiency (total sleep time/time spent in bed) indicates better sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder - 7 Item (GAD-7; Spitzer et al., 2006)</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>This 7-item measure assesses anxiety symptom severity. Items are scored from zero to three. The whole scale score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire 8 (PHQ-8; Kroenke et al., 2009)</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>An 8-item self-report instrument used to assess depression severity. Since the scale is self-administered in our studies and further probing about positive responses is not feasible, the question about suicide from the PHQ-9 was removed. Items are scored 0 to 3, with the total score being the sum of the 8 items. Higher scores indicate greater depression severity, with a score of 10 or greater considered major depression, and scores of 20 or more is severe major depression.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Insomnia</condition>
  <condition>Trauma, Psychological</condition>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Assessment only condition for all 12 weeks of participation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insomnia Coach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention condition that involves use of the Insomnia Coach app for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Insomnia Coach</intervention_name>
    <description>Insomnia Coach is a mobile application that provides psychoeducation and self-management tools for insomnia symptoms based on cognitive behavioral therapy for insomnia (CBT-I)</description>
    <arm_group_label>Insomnia Coach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 55&#xD;
&#xD;
          -  Owner of smartphone or tablet with Android or iOS operating system&#xD;
&#xD;
          -  Probable insomnia (i.e., ISI &gt;=10, 3 months or more with sxs, occurring &gt;= 3&#xD;
             days/week, 30 minutes or &gt; with sleep loss)&#xD;
&#xD;
          -  Able to read/write English&#xD;
&#xD;
          -  Internet connection and active email address&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Comorbid sleep disorders (apnea, RLS, narcolepsy)*&#xD;
&#xD;
          -  Started or changed dosage of sleep medications or SSRIs in past 2 months&#xD;
&#xD;
          -  Unstable housing&#xD;
&#xD;
          -  Medical condition identifiably causing sleep problems&#xD;
&#xD;
          -  Significant alcohol/drug use issues&#xD;
&#xD;
          -  Current mania or psychosis&#xD;
&#xD;
          -  Currently severely depressed (PHQ-9 &gt;20)&#xD;
&#xD;
          -  Currently receiving or having recently received insomnia therapy resembling CBT-I&#xD;
&#xD;
          -  Shift working&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Newborn (3 mos. or younger) living in residence&#xD;
&#xD;
          -  &lt; 5 hours of average total sleep time on 7 days of sleep diaries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>VA Palo Alto Health Care System</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>October 14, 2021</last_update_submitted>
  <last_update_submitted_qc>October 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA Palo Alto Health Care System</investigator_affiliation>
    <investigator_full_name>Eric Kuhn</investigator_full_name>
    <investigator_title>Clinical Psychologist</investigator_title>
  </responsible_party>
  <keyword>mobile app</keyword>
  <keyword>Veteran</keyword>
  <keyword>cognitive behavioral therapy for insomnia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Psychological Trauma</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/NCT03826849
org study id: IRB-47188
nct id: NCT03826849
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study is designed to test the feasibility, acceptability, and potential
      effectiveness of a mobile phone application (app) developed by the VA National Center for
      PTSD (VA NCPTSD) for use by Veterans with insomnia. The primary objective is to assess
      whether Veterans find the Insomnia Coach app to be satisfactory and feasible to use.
      Secondary objectives are to determine if use of the app improves subjective sleep quality and
      sleep parameters (e.g., sleep latency, wake after sleep onset, and total sleep time), as well
      as other important outcomes (e.g., daily functioning).
There are high rates of insomnia among Veterans, particularly those who have been exposed to
      potentially traumatic situations (i.e., combat exposure) and few receive cognitive-behavioral
      therapy for insomnia (CBT-I), a first-line treatment for insomnia. Insomnia Coach is a mobile
      app for individuals with insomnia symptoms. This app provides:

        -  education about sleep, the development of insomnia, and evidence based behavioral and
           cognitive strategies

        -  self-assessment tools measuring insomnia severity and sleep need

        -  self-monitoring with a daily sleep diary

        -  self-management tools for relaxation and changing thinking about sleep

        -  individualized recommendations for a preferable sleep window (i.e., bed and rise times)

        -  daily reminders for behavioral changes In this pilot randomized controlled trial (RCT),
           50 Veterans with significant insomnia symptoms will be recruited using flyers and social
           media (i.e., Facebook ads) and randomized in equal numbers to receive one of two
           conditions: 1) the Insomnia Coach mobile app (which is based on cognitive-behavioral
           therapy for insomnia (CBT-I)) and, 2) a waitlist control.

      Objective use of the Insomnia Coach mobile app will be tracked to assess feasibility (i.e.,
      will participants use the app as intended). Participants will complete measures (using
      Qualtrics) of sleep, insomnia severity, depression and anxiety, and functional well-being at
      baseline, 6 weeks (posttreatment), and 12 weeks (follow-up). At post-treatment, participants
      in the Insomnia Coach app condition will also be asked to report their level of satisfaction
      with the app and to complete a brief qualitative evaluation of their experience using the
      app. Waitlist control condition participants will be informed about the Insomnia Coach app
      and provided with information on how to download it after completion of the follow-up
      assessment (i.e., at 12 weeks).

      The aim of this research is to learn whether individuals, particularly Veterans, with
      insomnia, find Insomnia Coach to be satisfactory and feasible to use. It also aims to assess
      if use of the app potentially improves subjective sleep quality and sleep parameters (e.g.,
      sleep latency, wake after sleep onset, and total sleep time), as well as other important
      outcomes (e.g., daily functioning). If this research demonstrates that Insomnia Coach is a
      promising tool for individuals experiencing sleep difficulties, it has the potential to
      address a need using a very cost-effective, widely accessible, scalable solution that would
      warrant more rigorous evaluation (e.g., a full-scale RCT).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective App Usage Data
time frame: 6 weeks
description: Composite of app usage data comprised of button taps, sections visited, self-entered data, number of visits and days used, and time spent on the app per visit. Various combinations and aggregations of these behaviors will be explored as best indicators to optimally summarize app use.
measure: Mobile Apps Rating Scale (MARS; Stoyanov et al., 2015)
time frame: 6 weeks
description: A 20-item multidimensional, objective measure of app usability. It includes four subscales that measure an app's engagement, functionality, aesthetics, and information quality. All items are rated on a 5-point scale from "1. Inadequate" to "5. Excellent". The scores are tallied up and a mean score out of 5 is given to each of the categories scored.
measure: System Usability Scale (SUS; Brooke, 1986)
time frame: 6 weeks
description: A 10-item questionnaire of usability of products and services, including hardware, software, mobile devices, websites and applications. Items are on a 5-point scale numbered 1 to 5. Half of the items are worded negatively and half are worded positively. SUS yields a single number representing a composite measure of the overall usability of the system. To calculate the SUS score, the score contributions from each item are summed. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Then the sum of the scores is multiplied by 2.5 to obtain the overall value of SU. SUS scores have a range of 0 to 100.
measure: Qualitative Interview (Kuhn & Miller, 2018)
time frame: 6 weeks
description: A 24-question, semi-structured interview to assess users' perceptions of Insomnia Coach.
measure: Insomnia Severity Index (ISI; Bastien et al., 2011)
time frame: 6 and 12 weeks
description: A 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia symptoms in the past month. Items are on a scale from 0 to 4. The seven answers are added up to get a total score, with higher scores reflecting greater insomnia severity
measure: Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)
time frame: 6 and 12 weeks
description: A 19-item self-report measure assessing qualities and problems associated with sleep in the past month. It generates seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. A global sleep quality score is obtained by summing the seven component scores. Higher scores reflect poorer sleep quality. The global score ranges from 0 to 21, with a cut-off score of 5 as distinguishing "good" sleepers from "poor" sleepers.
measure: PROMIS-Sleep-Related Impairment (PROMIS-SRI; Buysse et al., 2010)
time frame: 6 and 12 weeks
description: This 16-item self-report form assesses sleep-related impairment over the past seven days. Each question has five response options ranging in value from 1 to 5. To find the total raw score the values of the response to each question are summed. The raw scores are converted to a standardized T-score using conversion tables published on the PROMIS website (nihpromis.org), with higher scores indicating greater sleep/wake disturbances.
measure: Consensus Sleep Diary: Change in sleep onset latency (Carney et al., 2012)
time frame: 6 and 12 weeks
description: The Consensus Sleep Diary will be used to prospectively monitor self-reported sleep. Shorter sleep onset indicates faster time to fall asleep.
measure: Consensus Sleep Diary: Change in wake after sleep onset (Carney et al., 2012)
time frame: 6 and 12 weeks
description: The Consensus Sleep Diary will be used to prospectively monitor self-reported sleep. Less time spent awake during the sleep period indicates better sleep.
measure: Consensus Sleep Diary: Change in sleep efficiency (Carney et al., 2012)
time frame: 6 and 12 weeks
description: The Consensus Sleep Diary will be used to prospectively monitor self-reported sleep. Higher sleep efficiency (total sleep time/time spent in bed) indicates better sleep quality.
measure: Generalized Anxiety Disorder - 7 Item (GAD-7; Spitzer et al., 2006)
time frame: 6 and 12 weeks
description: This 7-item measure assesses anxiety symptom severity. Items are scored from zero to three. The whole scale score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively.
measure: Patient Health Questionnaire 8 (PHQ-8; Kroenke et al., 2009)
time frame: 6 and 12 weeks
description: An 8-item self-report instrument used to assess depression severity. Since the scale is self-administered in our studies and further probing about positive responses is not feasible, the question about suicide from the PHQ-9 was removed. Items are scored 0 to 3, with the total score being the sum of the 8 items. Higher scores indicate greater depression severity, with a score of 10 or greater considered major depression, and scores of 20 or more is severe major depression.
arm group label: Waitlist Control
arm group type: No Intervention
description: Assessment only condition for all 12 weeks of participation.
arm group label: Insomnia Coach
arm group type: Experimental
description: Intervention condition that involves use of the Insomnia Coach app for 6 weeks.
intervention type: Behavioral
intervention name: Insomnia Coach
description: Insomnia Coach is a mobile application that provides psychoeducation and self-management tools for insomnia symptoms based on cognitive behavioral therapy for insomnia (CBT-I)
arm group label: Insomnia Coach
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: VA Palo Alto Health Care System
investigator full name: Eric Kuhn
investigator title: Clinical Psychologist
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Psychological Trauma
sharing ipd: No