<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/NCT04445805</url>
  </required_header>
  <id_info>
    <org_study_id>INSPIRE</org_study_id>
    <nct_id>NCT04445805</nct_id>
  </id_info>
  <brief_title>Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms</brief_title>
  <acronym>INSPIRE</acronym>
  <official_title>The INSPIRE Trial: Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health 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>
      The purpose of this research is to evaluate telemedicine treatments for sleep in pregnant&#xD;
      women. As pregnant women are vulnerable to sleep problems, the investigators aim to explore&#xD;
      whether these types of treatment will improve sleep and mood-related health risks in&#xD;
      pregnancy and postpartum. The investigators will test the efficacy of cognitive behavioral&#xD;
      therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal&#xD;
      insomnia relative to sleep education and hygiene, which is a minimal intervention control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this randomized controlled trial is to determine the efficacy of cognitive&#xD;
      behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for&#xD;
      perinatal insomnia relative to sleep education and hygiene, which is a minimal intervention&#xD;
      control. The long-term goal is to maximize the effectiveness of insomnia treatment for&#xD;
      perinatal women by adapting safe and efficacious treatments to meet the evolving needs of&#xD;
      women through pregnancy and postpartum. Over half of pregnant women develop insomnia, which&#xD;
      is associated with high rates of depression during pregnancy and postpartum. By successfully&#xD;
      treating insomnia during pregnancy and improving cognitive-emotion regulation, mental health&#xD;
      of pregnant and postpartum women may be substantially improved. In a prior clinical trial,&#xD;
      Dr. Kalmbach (PI) showed that digital CBTI (i.e., fully automated online program) improved&#xD;
      sleep during pregnancy, and offered some protection against sleep problems after childbirth.&#xD;
      Women in this prior trial were highly satisfied with CBTI and the ability to participate in&#xD;
      treatment remotely. However, the investigators identified important shortcomings of CBTI in&#xD;
      this population. Namely, standard CBTI was ineffective at reducing cognitive arousal and&#xD;
      depression. Preliminary data suggest that MBTI may effectively reduce cognitive arousal in&#xD;
      insomnia patients, which has immense potential to enhance sleep and mental health outcomes in&#xD;
      perinatal insomnia. Thus, the investigators will conduct a randomized controlled trial to&#xD;
      determine the efficacy of MBTI and CBTI for perinatal insomnia relative to a minimal&#xD;
      intervention control.&#xD;
&#xD;
      The current study is a 3-arm RCT comparing CBTI and MBTI to sleep education and hygiene&#xD;
      minimal intervention control for the treatment of perinatal insomnia. 120 women with insomnia&#xD;
      symptoms will be treated beginning in pregnancy and into early postpartum. CBTI and MBTI will&#xD;
      address changes in sleep symptoms and challenges that emerge after childbirth. The&#xD;
      investigators will collect outcome data on insomnia symptoms and related health outcomes&#xD;
      (e.g., cognitive arousal, depression) after prenatal treatment and monthly across the first&#xD;
      postpartum year. The investigators will determine the efficacy of the investigator's CBTI and&#xD;
      MBTI protocols for perinatal insomnia relative to minimal intervention control. The&#xD;
      investigators will then compare the effects of CBTI and MBTI on short- and long-term&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 15, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Effectiveness of mindfulness based therapy for insomnia for changes in insomnia symptoms - Insomnia Severity Index (ISI)</measure>
    <time_frame>Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year</time_frame>
    <description>The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated for use in community samples and clinical trials. The ISI scores range from 0-28, with a higher score indicating a greater severity of insomnia. ISI scores &lt; 8 after treatment indicate remission.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of mindfulness based therapy for insomnia for changes in depression symptoms- Edinburgh Postnatal Depression Scale (EPDS)</measure>
    <time_frame>Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year</time_frame>
    <description>The Edinburgh Postnatal Depression (EPDS) is the most widely used depression measure in both pregnant and postnatal women. It is validated for use in community samples and clinical trials. The EPDS scores range from 0-30, with a higher score indicating a greater severity of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of mindfulness based therapy for insomnia for changes in cognitive arousal - Presleep Arousal Scale-Cognitive Factor</measure>
    <time_frame>Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year</time_frame>
    <description>The Presleep Arousal Scale- Cognitive Factor is a commonly used self-report measure of nocturnal cognitive arousal that has been validated for use in community samples and clinical trials. The scores range from 8-40, with a higher score indicating a greater severity of nocturnal cognitive arousal.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>CBTI Treatment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telemedicine Cognitive Behavioral Therapy for Insomnia (CBTI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Perinatal-enhanced behavioral therapy for insomnia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telemedicine Mindfulness Based Therapy for Insomnia (MBTI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control Treatment Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Minimal intervention control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy for Insomnia (CBTI)</intervention_name>
    <description>Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, cognitive therapy, and relaxation. Treatment will be delivered via telemedicine.</description>
    <arm_group_label>CBTI Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Perinatal-enhanced Behavioral Therapy for Insomnia</intervention_name>
    <description>Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, and metacognitive exercises. Treatment will be delivered via telemedicine.</description>
    <arm_group_label>Perinatal-enhanced behavioral therapy for insomnia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control</intervention_name>
    <description>Will include education on sleep, circadian rhythms, and good sleep hygiene in addition to self-monitoring with sleep diaries.</description>
    <arm_group_label>Attention Control Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) Gestational age at time of study enrollment must be less than or equal to 28 weeks&#xD;
&#xD;
          -  (2) Insomnia Severity Index score &gt; 10&#xD;
&#xD;
          -  (3) age 18 - 40 years&#xD;
&#xD;
          -  (4) reliable and adequately fast internet connection at home, which is required to&#xD;
             engage in telemedicine treatment (online video) and online study outcome assessments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High risk pregnancy (e.g., pre-eclampsia, multiple pregnancy, age&gt;40)&#xD;
&#xD;
          -  Bipolar disorder (contraindicated for CBTI)&#xD;
&#xD;
          -  Seizures (contraindicated for CBTI)&#xD;
&#xD;
          -  Active suicidal intent&#xD;
&#xD;
          -  Shift work&#xD;
&#xD;
          -  Patients who cannot reasonably engage in study activities including treatment or&#xD;
             completing online surveys will be excluded regardless of reason. This may include&#xD;
             inability to comprehend the English language, inability to hear therapist over video&#xD;
             sessions, inability to understand and meaningfully answer study outcomes measures, or&#xD;
             other barriers to participation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Kalmbach, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henry Ford Medical Center</name>
      <address>
        <city>Novi</city>
        <state>Michigan</state>
        <zip>48377</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>December 12, 2022</last_update_submitted>
  <last_update_submitted_qc>December 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>David Kalmbach</investigator_full_name>
    <investigator_title>Bioscientific Staff Researcher</investigator_title>
  </responsible_party>
  <keyword>Insomnia</keyword>
  <keyword>Telemedecine</keyword>
  <keyword>pregnancy</keyword>
  <keyword>perinatal</keyword>
  <keyword>Cognitive Arousal</keyword>
  <keyword>depression</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>Undecided</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/NCT04445805
org study id: INSPIRE
nct id: NCT04445805
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research is to evaluate telemedicine treatments for sleep in pregnant
      women. As pregnant women are vulnerable to sleep problems, the investigators aim to explore
      whether these types of treatment will improve sleep and mood-related health risks in
      pregnancy and postpartum. The investigators will test the efficacy of cognitive behavioral
      therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal
      insomnia relative to sleep education and hygiene, which is a minimal intervention control.
The purpose of this randomized controlled trial is to determine the efficacy of cognitive
      behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for
      perinatal insomnia relative to sleep education and hygiene, which is a minimal intervention
      control. The long-term goal is to maximize the effectiveness of insomnia treatment for
      perinatal women by adapting safe and efficacious treatments to meet the evolving needs of
      women through pregnancy and postpartum. Over half of pregnant women develop insomnia, which
      is associated with high rates of depression during pregnancy and postpartum. By successfully
      treating insomnia during pregnancy and improving cognitive-emotion regulation, mental health
      of pregnant and postpartum women may be substantially improved. In a prior clinical trial,
      Dr. Kalmbach (PI) showed that digital CBTI (i.e., fully automated online program) improved
      sleep during pregnancy, and offered some protection against sleep problems after childbirth.
      Women in this prior trial were highly satisfied with CBTI and the ability to participate in
      treatment remotely. However, the investigators identified important shortcomings of CBTI in
      this population. Namely, standard CBTI was ineffective at reducing cognitive arousal and
      depression. Preliminary data suggest that MBTI may effectively reduce cognitive arousal in
      insomnia patients, which has immense potential to enhance sleep and mental health outcomes in
      perinatal insomnia. Thus, the investigators will conduct a randomized controlled trial to
      determine the efficacy of MBTI and CBTI for perinatal insomnia relative to a minimal
      intervention control.

      The current study is a 3-arm RCT comparing CBTI and MBTI to sleep education and hygiene
      minimal intervention control for the treatment of perinatal insomnia. 120 women with insomnia
      symptoms will be treated beginning in pregnancy and into early postpartum. CBTI and MBTI will
      address changes in sleep symptoms and challenges that emerge after childbirth. The
      investigators will collect outcome data on insomnia symptoms and related health outcomes
      (e.g., cognitive arousal, depression) after prenatal treatment and monthly across the first
      postpartum year. The investigators will determine the efficacy of the investigator's CBTI and
      MBTI protocols for perinatal insomnia relative to minimal intervention control. The
      investigators will then compare the effects of CBTI and MBTI on short- and long-term
      outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness of mindfulness based therapy for insomnia for changes in insomnia symptoms - Insomnia Severity Index (ISI)
time frame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
description: The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated for use in community samples and clinical trials. The ISI scores range from 0-28, with a higher score indicating a greater severity of insomnia. ISI scores < 8 after treatment indicate remission.
measure: Effectiveness of mindfulness based therapy for insomnia for changes in depression symptoms- Edinburgh Postnatal Depression Scale (EPDS)
time frame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
description: The Edinburgh Postnatal Depression (EPDS) is the most widely used depression measure in both pregnant and postnatal women. It is validated for use in community samples and clinical trials. The EPDS scores range from 0-30, with a higher score indicating a greater severity of depression.
measure: Effectiveness of mindfulness based therapy for insomnia for changes in cognitive arousal - Presleep Arousal Scale-Cognitive Factor
time frame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
description: The Presleep Arousal Scale- Cognitive Factor is a commonly used self-report measure of nocturnal cognitive arousal that has been validated for use in community samples and clinical trials. The scores range from 8-40, with a higher score indicating a greater severity of nocturnal cognitive arousal.
arm group label: CBTI Treatment Group
arm group type: Active Comparator
description: Telemedicine Cognitive Behavioral Therapy for Insomnia (CBTI)
arm group label: Perinatal-enhanced behavioral therapy for insomnia
arm group type: Experimental
description: Telemedicine Mindfulness Based Therapy for Insomnia (MBTI)
arm group label: Attention Control Treatment Group
arm group type: Placebo Comparator
description: Minimal intervention control
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy for Insomnia (CBTI)
description: Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, cognitive therapy, and relaxation. Treatment will be delivered via telemedicine.
arm group label: CBTI Treatment Group
intervention type: Behavioral
intervention name: Perinatal-enhanced Behavioral Therapy for Insomnia
description: Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, and metacognitive exercises. Treatment will be delivered via telemedicine.
arm group label: Perinatal-enhanced behavioral therapy for insomnia
intervention type: Behavioral
intervention name: Attention Control
description: Will include education on sleep, circadian rhythms, and good sleep hygiene in addition to self-monitoring with sleep diaries.
arm group label: Attention Control Treatment Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: David Kalmbach, PhD
role: Principal Investigator
affiliation: Henry Ford Health System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: David Kalmbach
investigator title: Bioscientific Staff Researcher
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: Undecided