<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/NCT04443959</url>
  </required_header>
  <id_info>
    <org_study_id>PPD2</org_study_id>
    <nct_id>NCT04443959</nct_id>
  </id_info>
  <brief_title>Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.</brief_title>
  <official_title>Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.</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>
      Over half of pregnant and postpartum women experience clinical insomnia. However, treatment&#xD;
      options are very limited for pregnant women and moms of newborns. Sleep aids are not&#xD;
      considered safe during pregnancy and may increase risks about safety for mom and baby during&#xD;
      postpartum. Recent clinical trials show that behavioral and mindfulness-based treatments can&#xD;
      safely improve sleep and mood during pregnancy. Yet, no published studies to date have&#xD;
      combined behavioral sleep treatment with mindfulness-based stress reduction to improve sleep&#xD;
      and mood at the same time in pregnant and postpartum women. This study is the first to&#xD;
      combine behavioral sleep strategies with mindfulness-meditation to improve sleep and&#xD;
      psychological wellbeing of expecting and new moms.&#xD;
&#xD;
      The purpose of this research study is to examine the effectiveness of a mindfulness-based&#xD;
      intervention for prenatal insomnia via telemedicine format to improve sleep and mood as well&#xD;
      as reduce stress in pregnant women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this open-label trial is to determine the efficacy of and patient engagement&#xD;
      in mindfulness-based intervention for prenatal insomnia delivered via telemedicine. The&#xD;
      investigators' long-term goal is to improve sleep and mood of expecting and new mothers. Over&#xD;
      half of pregnant women develop insomnia, which is associated with high rates of depression&#xD;
      during pregnancy and postpartum. By successfully treating insomnia during pregnancy and&#xD;
      improving cognitive-emotion regulation, mental health of pregnant women and new moms may be&#xD;
      greatly improved. In a prior clinical trial, Dr. Kalmbach (PI) showed that online&#xD;
      cognitive-behavioral therapy for insomnia (CBTI) greatly improved sleep during pregnancy, and&#xD;
      offered some protection against sleep problems after childbirth. Women in this trial were&#xD;
      highly satisfied with CBTI and especially its remote delivery. However, the investigators&#xD;
      identified important shortcomings of online CBTI in this population. Namely, patients&#xD;
      provided feedback that reducing cognitive arousal (ie ruminative or worrisome thinking) was&#xD;
      an important therapeutic target, that more mindfulness-based approaches and strategies would&#xD;
      improve treatment, and that greater emphasis on maternal and infant sleep would also enhance&#xD;
      the treatment experience. Thus, the investigators will conduct an open label trial to collect&#xD;
      pilot data on the efficacy of a telemedicine mindfulness-based intervention for prenatal&#xD;
      insomnia that has been tailored for pregnant women. Specifically, the investigators will&#xD;
      conduct this open-label trial of 50 pregnant women to preliminary test the efficacy, patient&#xD;
      adherence, patient engagement, and patient satisfaction with this telemedicine program.&#xD;
&#xD;
      This open-label trial will enroll 50 pregnant women (gestational age 18-30 weeks at study&#xD;
      entry) who will receive 6 sessions of 'Perinatal Understanding of Mindful Awareness for&#xD;
      Sleep' (PUMAS) via telemedicine video with a therapist. Patients will complete this treatment&#xD;
      during pregnancy. This program was based on Dr. Jason Ong's Mindfulness-Based Therapy for&#xD;
      Insomnia, which combined CBTI and mindfulness meditation, and it has been tailored for&#xD;
      perinatal women. The investigators will assess study outcomes before treatment and after&#xD;
      treatment. Study outcomes will include insomnia symptoms, depressive symptoms, and cognitive&#xD;
      arousal. The investigators will also assess patient engagement (number of completed sessions,&#xD;
      homework adherence) and collect patient feedback (e.g., treatment satisfaction).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2022</start_date>
  <completion_date type="Actual">November 22, 2022</completion_date>
  <primary_completion_date type="Actual">November 22, 2022</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>Effectiveness of PUMAS for changes in insomnia symptoms - Insomnia Severity Index (ISI)</measure>
    <time_frame>Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).</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 PUMAS for changes in depressive symptoms</measure>
    <time_frame>Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).</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 PUMAS for changes in of cognitive arousal- Presleep Arousal Scale- Cognitive Factor</measure>
    <time_frame>Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).</time_frame>
    <description>The Presleep Arousal Scale - Cognitive Factor is a commonly used self-report measure of insomnia symptoms 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>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>PUMAS Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prenatal insomnia program that places behavioral sleep strategies within a mindfulness-based intervention framework that is geared toward pregnant women.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PUMAS</intervention_name>
    <description>Treatment consists of 6 weekly telemedicine sessions during pregnancy.</description>
    <arm_group_label>PUMAS Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) Gestational age at time of study enrollment must be 18-30 weeks.&#xD;
&#xD;
          -  (2) Insomnia Severity Index score of 11 or higher&#xD;
&#xD;
          -  (3) age between 18 and 40 years&#xD;
&#xD;
          -  (4) reliable and adequately fast internet connection at home, which is required to&#xD;
             engage in online treatment and online study outcome assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) High risk pregnancy as reported by the patient, which includes but is not limited&#xD;
             to pre-eclampsia, gestational diabetes, maternal age &gt; 40, ectopic pregnancy, fetal&#xD;
             problems (e.g., heart problems), hyperemesis gravidarum, placenta previa, and&#xD;
             placental abruption.&#xD;
&#xD;
          -  (2) bipolar disorder or seizure disorders [contraindicated for insomnia therapy] as&#xD;
             reported by the patient&#xD;
&#xD;
          -  (3) women with multiple pregnancy (e.g., twins, triplets, etc.) will not be eligible&#xD;
             to participate as multiple pregnancy can increase risk of complications and often&#xD;
             leads to preterm or early-term birth&#xD;
&#xD;
          -  (4) any conditions or difficulties that would prevent the patient from completing&#xD;
             online treatment and/or online surveys, including but not limited to language&#xD;
             difficulties, literacy issues, visual or auditory impairment, and cognitive deficits&#xD;
&#xD;
          -  (5) active suicidal intent&#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 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 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>Mindfulness</keyword>
  <keyword>Cognitive arousal</keyword>
  <keyword>insomnia</keyword>
  <keyword>pregnant</keyword>
  <keyword>perinatal</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/NCT04443959
org study id: PPD2
nct id: NCT04443959
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Over half of pregnant and postpartum women experience clinical insomnia. However, treatment
      options are very limited for pregnant women and moms of newborns. Sleep aids are not
      considered safe during pregnancy and may increase risks about safety for mom and baby during
      postpartum. Recent clinical trials show that behavioral and mindfulness-based treatments can
      safely improve sleep and mood during pregnancy. Yet, no published studies to date have
      combined behavioral sleep treatment with mindfulness-based stress reduction to improve sleep
      and mood at the same time in pregnant and postpartum women. This study is the first to
      combine behavioral sleep strategies with mindfulness-meditation to improve sleep and
      psychological wellbeing of expecting and new moms.

      The purpose of this research study is to examine the effectiveness of a mindfulness-based
      intervention for prenatal insomnia via telemedicine format to improve sleep and mood as well
      as reduce stress in pregnant women.
The purpose of this open-label trial is to determine the efficacy of and patient engagement
      in mindfulness-based intervention for prenatal insomnia delivered via telemedicine. The
      investigators' long-term goal is to improve sleep and mood of expecting and new mothers. 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 women and new moms may be
      greatly improved. In a prior clinical trial, Dr. Kalmbach (PI) showed that online
      cognitive-behavioral therapy for insomnia (CBTI) greatly improved sleep during pregnancy, and
      offered some protection against sleep problems after childbirth. Women in this trial were
      highly satisfied with CBTI and especially its remote delivery. However, the investigators
      identified important shortcomings of online CBTI in this population. Namely, patients
      provided feedback that reducing cognitive arousal (ie ruminative or worrisome thinking) was
      an important therapeutic target, that more mindfulness-based approaches and strategies would
      improve treatment, and that greater emphasis on maternal and infant sleep would also enhance
      the treatment experience. Thus, the investigators will conduct an open label trial to collect
      pilot data on the efficacy of a telemedicine mindfulness-based intervention for prenatal
      insomnia that has been tailored for pregnant women. Specifically, the investigators will
      conduct this open-label trial of 50 pregnant women to preliminary test the efficacy, patient
      adherence, patient engagement, and patient satisfaction with this telemedicine program.

      This open-label trial will enroll 50 pregnant women (gestational age 18-30 weeks at study
      entry) who will receive 6 sessions of 'Perinatal Understanding of Mindful Awareness for
      Sleep' (PUMAS) via telemedicine video with a therapist. Patients will complete this treatment
      during pregnancy. This program was based on Dr. Jason Ong's Mindfulness-Based Therapy for
      Insomnia, which combined CBTI and mindfulness meditation, and it has been tailored for
      perinatal women. The investigators will assess study outcomes before treatment and after
      treatment. Study outcomes will include insomnia symptoms, depressive symptoms, and cognitive
      arousal. The investigators will also assess patient engagement (number of completed sessions,
      homework adherence) and collect patient feedback (e.g., treatment satisfaction).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness of PUMAS for changes in insomnia symptoms - Insomnia Severity Index (ISI)
time frame: Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).
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 PUMAS for changes in depressive symptoms
time frame: Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).
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 PUMAS for changes in of cognitive arousal- Presleep Arousal Scale- Cognitive Factor
time frame: Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).
description: The Presleep Arousal Scale - Cognitive Factor is a commonly used self-report measure of insomnia symptoms 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: PUMAS Treatment
arm group type: Experimental
description: Prenatal insomnia program that places behavioral sleep strategies within a mindfulness-based intervention framework that is geared toward pregnant women.
intervention type: Behavioral
intervention name: PUMAS
description: Treatment consists of 6 weekly telemedicine sessions during pregnancy.
arm group label: PUMAS Treatment
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