<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/NCT02988375</url>
  </required_header>
  <id_info>
    <org_study_id>10320</org_study_id>
    <nct_id>NCT02988375</nct_id>
  </id_info>
  <brief_title>Sleep to Prevent Evolving Affecting Disorders</brief_title>
  <acronym>SPREAD</acronym>
  <official_title>Sleep to Prevent Evolving Affecting Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Robert Wood Johnson 1R56MH115150-01</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the proposed research is to determine the efficacy of Digital&#xD;
      Cognitive Behavior Therapy (dCBTI) in reducing severity of depression and also in preventing&#xD;
      the incidence and relapse of depression among insomniacs. In addition, we will identify&#xD;
      salient sociological/environmental variables, such as age, sex, education, socioeconomic&#xD;
      status (SES), racial/ethnic minority-status, work schedule, child-care responsibilities&#xD;
      (i.e., having children under the age of 3), stigma, that moderate the effects of this&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine the effectiveness of Digital Cognitive Behavior&#xD;
      Therapy for Insomnia (dCBTI) in reducing severity of depression and also in preventing the&#xD;
      incidence and relapse of depression among insomniacs. dCBTI is an online form of Cognitive&#xD;
      Behavioral Therapy (CBT) used with people who experience trouble sleeping at night&#xD;
      (insomniacs). This study will allow us to determine whether this form of digital therapy is&#xD;
      helpful in reducing the severity of depression and in preventing the development and relapse&#xD;
      of depression in people suffering from insomnia.&#xD;
&#xD;
      Participants will be recruited from several well-developed sources, including the HFHS Sleep&#xD;
      Center Clinical database. Once a participant meets inclusion criteria and provides consent, a&#xD;
      link to the internet portal will be provided to complete the remaining survey questions.&#xD;
      After completion of this assessment, participants will be automatically randomized to one of&#xD;
      2 active online insomnia treatment conditions. Each treatment involves 6 weekly &quot;sessions&quot;&#xD;
      which each take up to 20 minutes to complete.&#xD;
&#xD;
      A post-treatment questionnaire immediately following the 6-week treatment phase will be&#xD;
      completed. In addition, a follow up questionnaire assessment will be completed approximately&#xD;
      1 year after treatment. Each of the 3 separate questionnaires will take 20-30 minutes to&#xD;
      complete. Participants will be compensated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2016</start_date>
  <completion_date type="Actual">September 13, 2018</completion_date>
  <primary_completion_date type="Actual">April 26, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of Depression</measure>
    <time_frame>Pre-treatment (Day 1)</time_frame>
    <description>Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) and incidence of depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevention of Incident Depression (Post-treatment)</measure>
    <time_frame>Post-treatment (~6 week after Screening)</time_frame>
    <description>Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevention of Depression Relapse 1-years Post Treatment</measure>
    <time_frame>1-year follow-up (58 week after screening)</time_frame>
    <description>Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of Symptoms of Insomnia - Post Treatment</measure>
    <time_frame>Post-treatment (~6 week after Screening)</time_frame>
    <description>Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Symptoms of Insomnia - 1 year Post Treatment</measure>
    <time_frame>1-year follow-up (58 week after screening)</time_frame>
    <description>Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1385</enrollment>
  <condition>Insomnia, Primary</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>dCBTI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Online access to the digital CBTI program Sleepio</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep Education</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Weekly email messages with sleep hygiene recommendations</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>dCBTI</intervention_name>
    <arm_group_label>dCBTI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Education</intervention_name>
    <arm_group_label>Sleep Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meets Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition(DSMV)&#xD;
             criteria for insomnia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of insomnia, untreated sleep disorder (e.g., obstructive sleep apnea, restless&#xD;
             leg syndrome), bipolar disorder, history of seizure disorder, high depression&#xD;
             chronicity (self-reported daily or near daily depressed mood and anhedonia)&#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>Christopher Drake, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Medical Center - Columbus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>October 29, 2018</last_update_submitted>
  <last_update_submitted_qc>October 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Christopher Drake</investigator_full_name>
    <investigator_title>Director of Sleep Research</investigator_title>
  </responsible_party>
  <keyword>insomnia</keyword>
  <keyword>depression</keyword>
  <keyword>digital CBTI</keyword>
  <keyword>online CBTI</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>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 16, 2022</submitted>
  </pending_results>
  <!-- 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/NCT02988375
org study id: 10320
nct id: NCT02988375
lead sponsor: 
collaborator: 
has dmc: No
The primary objective of the proposed research is to determine the efficacy of Digital
      Cognitive Behavior Therapy (dCBTI) in reducing severity of depression and also in preventing
      the incidence and relapse of depression among insomniacs. In addition, we will identify
      salient sociological/environmental variables, such as age, sex, education, socioeconomic
      status (SES), racial/ethnic minority-status, work schedule, child-care responsibilities
      (i.e., having children under the age of 3), stigma, that moderate the effects of this
      intervention.
The purpose of this study is to determine the effectiveness of Digital Cognitive Behavior
      Therapy for Insomnia (dCBTI) in reducing severity of depression and also in preventing the
      incidence and relapse of depression among insomniacs. dCBTI is an online form of Cognitive
      Behavioral Therapy (CBT) used with people who experience trouble sleeping at night
      (insomniacs). This study will allow us to determine whether this form of digital therapy is
      helpful in reducing the severity of depression and in preventing the development and relapse
      of depression in people suffering from insomnia.

      Participants will be recruited from several well-developed sources, including the HFHS Sleep
      Center Clinical database. Once a participant meets inclusion criteria and provides consent, a
      link to the internet portal will be provided to complete the remaining survey questions.
      After completion of this assessment, participants will be automatically randomized to one of
      2 active online insomnia treatment conditions. Each treatment involves 6 weekly "sessions"
      which each take up to 20 minutes to complete.

      A post-treatment questionnaire immediately following the 6-week treatment phase will be
      completed. In addition, a follow up questionnaire assessment will be completed approximately
      1 year after treatment. Each of the 3 separate questionnaires will take 20-30 minutes to
      complete. Participants will be compensated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Severity of Depression
time frame: Pre-treatment (Day 1)
description: Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) and incidence of depression
measure: Prevention of Incident Depression (Post-treatment)
time frame: Post-treatment (~6 week after Screening)
description: Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
measure: Prevention of Depression Relapse 1-years Post Treatment
time frame: 1-year follow-up (58 week after screening)
description: Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
measure: Severity of Symptoms of Insomnia - Post Treatment
time frame: Post-treatment (~6 week after Screening)
description: Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
measure: Severity of Symptoms of Insomnia - 1 year Post Treatment
time frame: 1-year follow-up (58 week after screening)
description: Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
arm group label: dCBTI
arm group type: Experimental
description: Online access to the digital CBTI program Sleepio
arm group label: Sleep Education
arm group type: Placebo Comparator
description: Weekly email messages with sleep hygiene recommendations
intervention type: Behavioral
intervention name: dCBTI
arm group label: dCBTI
intervention type: Behavioral
intervention name: Sleep Education
arm group label: Sleep Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher Drake, PhD
role: Principal Investigator
affiliation: Henry Ford Medical Center - Columbus
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Christopher Drake
investigator title: Director of Sleep Research
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Depression
sharing ipd: No
submitted: December 16, 2022