<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/NCT03283254</url>
  </required_header>
  <id_info>
    <org_study_id>7428</org_study_id>
    <secondary_id>R01HD092062</secondary_id>
    <nct_id>NCT03283254</nct_id>
  </id_info>
  <brief_title>PREPP: Preventing Postpartum Depression</brief_title>
  <acronym>PREPP</acronym>
  <official_title>Preventing Postpartum Depression: A Dyadic Approach Adjunctive to Obstetric Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</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 primary aim of this study is to determine if a behavioral intervention targeting maternal&#xD;
      caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and&#xD;
      thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2)&#xD;
      improve the quality of the mother-infant interaction and subsequent child development.&#xD;
      Specifically, the study team will investigate: (1) the effectiveness of the intervention&#xD;
      compared to usual care; (2) if the effects of the intervention can be detected in the&#xD;
      assessments of the quality of mother-infant interaction; (3) if there are prenatal and/or&#xD;
      postnatal biomarkers that can help identify infants whose behavior is more likely to play a&#xD;
      role in their mothers' depression; (4) if these markers differentiate which infants will be&#xD;
      most responsive to the intervention(s); and (5), if assessments of brain function at birth&#xD;
      and at 4-6 weeks of age provide biological nodal points for identifying the effects of the&#xD;
      intervention on infant brain development. Participants will be recruited during their 2nd&#xD;
      trimester, and will be randomly separated into one of two groups: a group that receives&#xD;
      coaching in parenting techniques (4 in-person coaching sessions and 1 phone session) or one&#xD;
      that receives treatment as usual.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Of the nearly 4 million mothers delivering live births each year in the United States,&#xD;
      approximately 560,000 - or 14% - will develop major or minor depression within the first four&#xD;
      months postpartum, when the rate peaks. This number dwarfs prevalence rates for gestational&#xD;
      diabetes (2-5%) and is comparable to preterm birth (11.4%). Postpartum depression (PPD) has&#xD;
      substantial consequences: poorer maternal quality of life, significant emotional suffering,&#xD;
      and suicide risk. PPD predicts diminished mother-infant bonding, and poor outcomes in&#xD;
      social-emotional and, in some groups, cognitive development. PPD is undertreated in part&#xD;
      because women are reluctant to seek treatment due to the stigma associated with mental health&#xD;
      care, logistical barriers to at-tending added health care appointments, and disinclination to&#xD;
      take medications while breastfeeding. Of preventive interventions, few embed services in&#xD;
      obstetrical care or leverage the unique mother-infant dyadic orientation of the childbearing&#xD;
      period. The investigators developed a novel intervention based on the conceptualization of&#xD;
      maternal depression as a potential disorder of the mother-infant dyad, and one that can be&#xD;
      approached through psychological and behavioral changes in the mother - commencing before&#xD;
      birth - that affect her and the child. PREPP (Practical Resources for Effective Postpartum&#xD;
      Parenting) enrolls distressed pregnant women at risk for PPD, spans late pregnancy to the 6&#xD;
      week postpartum check up, comprises four in-person 'coaching' sessions adjunctive to&#xD;
      obstetrical (OB) prenatal and postnatal appointments, one phone session, and imparts (a)&#xD;
      mindfulness and self-reflection skills, (b) parenting skills, and (c) psycho-education.&#xD;
&#xD;
      The primary aim of this study is to determine if a behavioral intervention targeting maternal&#xD;
      caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and&#xD;
      thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2)&#xD;
      improve the quality of the mother-infant interaction and subsequent child development.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    The study is paused.&#xD;
  </why_stopped>
  <start_date type="Actual">February 12, 2018</start_date>
  <completion_date type="Anticipated">August 10, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</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>
    <intervention_model_description>Two groups: One receives PREPP prevention intervention and the other group receives Enhanced Treatment as Usual (psychoeducation about Postpartum Depression, referral and monitoring)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The person administering the outcome measures is blind to participant group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postpartum Depression Symptoms</measure>
    <time_frame>6-16 weeks postpartum</time_frame>
    <description>Postpartum Depression Symptoms measured by Edinburgh Postnatal Depression Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved Sleep</measure>
    <time_frame>3rd trimester of pregnancy - 16 weeks postpartum</time_frame>
    <description>Improved self-report of sleep quality on Pittsburgh Sleep Quality Index and improved sleep shown on actigraphy monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Behavior</measure>
    <time_frame>6 &amp; 16 weeks postpartum</time_frame>
    <description>Cry behavior and sleep behavior measured by The Baby Day Diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Greater infant left frontal EEG power reflecting sleep spindle activity</measure>
    <time_frame>Newborn-6 weeks postpartum</time_frame>
    <description>More positive perceptions and objective assessments of maternal postpartum sleep efficiency will be mediated by greater infant left frontal EEG power reflecting sleep spindle activity and associated longer average durations of infant nocturnal sleep per maternal report and actigraphy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Postpartum Depression</condition>
  <arm_group>
    <arm_group_label>Practical Resources for Effective Postpartum (PREPP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A psychotherapeutic preventive intervention that involves psychoeducation and cognitive behavioral techniques.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Treatment as Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Psychoeducation about Postpartum Depression, referral to treatment in the community and monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Practical Resources for Effective Postpartum Parenting</intervention_name>
    <description>A preventive psychotherapy intervention for Postpartum Depression</description>
    <arm_group_label>Practical Resources for Effective Postpartum (PREPP)</arm_group_label>
    <other_name>PREPP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Treatment As Usual</intervention_name>
    <description>Psychoeducation about Postpartum Depression, referral to treatment in the community, clinical monitoring</description>
    <arm_group_label>Enhanced Treatment as Usual</arm_group_label>
    <other_name>ETAU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy pregnant women between 18-45 years old (based on self report)&#xD;
&#xD;
          2. A score of ≥21 on the Predictive Index of Postnatal Depression (PIPD), indicating risk&#xD;
             for developing postpartum depression&#xD;
&#xD;
          3. A healthy, singleton pregnancy (based on self report)&#xD;
&#xD;
          4. English speaking (based on self report)&#xD;
&#xD;
          5. Receiving standard prenatal care (based on self report)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Multi-fetal pregnancy (based on self-report)&#xD;
&#xD;
          2. Smoking, illicit drug use, or alcohol use during pregnancy (based on self-report)&#xD;
&#xD;
          3. Acute medical illness or significant pregnancy complication (based on self-report)&#xD;
&#xD;
          4. Currently in weekly, individual psychotherapy, including psychopharmacology (based on&#xD;
             self report)&#xD;
&#xD;
          5. Psychotic d/o; Bipolar I; Major Depressive d/o (based on M.I.N.I.)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine Monk, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth Werner, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Catherine Monk</investigator_full_name>
    <investigator_title>Diana Vagelos Professor of Women's Mental Health (in Obstetrics and Gynecology and Psychiatry)</investigator_title>
  </responsible_party>
  <keyword>Postpartum Depression Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data may be made available to other researchers.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>After the completion of the study</ipd_time_frame>
    <ipd_access_criteria>Permission of the PI</ipd_access_criteria>
  </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/NCT03283254
org study id: 7428
secondary id: R01HD092062
nct id: NCT03283254
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is to determine if a behavioral intervention targeting maternal
      caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and
      thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2)
      improve the quality of the mother-infant interaction and subsequent child development.
      Specifically, the study team will investigate: (1) the effectiveness of the intervention
      compared to usual care; (2) if the effects of the intervention can be detected in the
      assessments of the quality of mother-infant interaction; (3) if there are prenatal and/or
      postnatal biomarkers that can help identify infants whose behavior is more likely to play a
      role in their mothers' depression; (4) if these markers differentiate which infants will be
      most responsive to the intervention(s); and (5), if assessments of brain function at birth
      and at 4-6 weeks of age provide biological nodal points for identifying the effects of the
      intervention on infant brain development. Participants will be recruited during their 2nd
      trimester, and will be randomly separated into one of two groups: a group that receives
      coaching in parenting techniques (4 in-person coaching sessions and 1 phone session) or one
      that receives treatment as usual.
Of the nearly 4 million mothers delivering live births each year in the United States,
      approximately 560,000 - or 14% - will develop major or minor depression within the first four
      months postpartum, when the rate peaks. This number dwarfs prevalence rates for gestational
      diabetes (2-5%) and is comparable to preterm birth (11.4%). Postpartum depression (PPD) has
      substantial consequences: poorer maternal quality of life, significant emotional suffering,
      and suicide risk. PPD predicts diminished mother-infant bonding, and poor outcomes in
      social-emotional and, in some groups, cognitive development. PPD is undertreated in part
      because women are reluctant to seek treatment due to the stigma associated with mental health
      care, logistical barriers to at-tending added health care appointments, and disinclination to
      take medications while breastfeeding. Of preventive interventions, few embed services in
      obstetrical care or leverage the unique mother-infant dyadic orientation of the childbearing
      period. The investigators developed a novel intervention based on the conceptualization of
      maternal depression as a potential disorder of the mother-infant dyad, and one that can be
      approached through psychological and behavioral changes in the mother - commencing before
      birth - that affect her and the child. PREPP (Practical Resources for Effective Postpartum
      Parenting) enrolls distressed pregnant women at risk for PPD, spans late pregnancy to the 6
      week postpartum check up, comprises four in-person 'coaching' sessions adjunctive to
      obstetrical (OB) prenatal and postnatal appointments, one phone session, and imparts (a)
      mindfulness and self-reflection skills, (b) parenting skills, and (c) psycho-education.

      The primary aim of this study is to determine if a behavioral intervention targeting maternal
      caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and
      thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2)
      improve the quality of the mother-infant interaction and subsequent child development.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups: One receives PREPP prevention intervention and the other group receives Enhanced Treatment as Usual (psychoeducation about Postpartum Depression, referral and monitoring)
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: The person administering the outcome measures is blind to participant group.
measure: Postpartum Depression Symptoms
time frame: 6-16 weeks postpartum
description: Postpartum Depression Symptoms measured by Edinburgh Postnatal Depression Scale
measure: Improved Sleep
time frame: 3rd trimester of pregnancy - 16 weeks postpartum
description: Improved self-report of sleep quality on Pittsburgh Sleep Quality Index and improved sleep shown on actigraphy monitor
measure: Infant Behavior
time frame: 6 & 16 weeks postpartum
description: Cry behavior and sleep behavior measured by The Baby Day Diary
measure: Greater infant left frontal EEG power reflecting sleep spindle activity
time frame: Newborn-6 weeks postpartum
description: More positive perceptions and objective assessments of maternal postpartum sleep efficiency will be mediated by greater infant left frontal EEG power reflecting sleep spindle activity and associated longer average durations of infant nocturnal sleep per maternal report and actigraphy.
arm group label: Practical Resources for Effective Postpartum (PREPP)
arm group type: Experimental
description: A psychotherapeutic preventive intervention that involves psychoeducation and cognitive behavioral techniques.
arm group label: Enhanced Treatment as Usual
arm group type: Active Comparator
description: Psychoeducation about Postpartum Depression, referral to treatment in the community and monitoring
intervention type: Behavioral
intervention name: Practical Resources for Effective Postpartum Parenting
description: A preventive psychotherapy intervention for Postpartum Depression
arm group label: Practical Resources for Effective Postpartum (PREPP)
other name: PREPP
intervention type: Behavioral
intervention name: Enhanced Treatment As Usual
description: Psychoeducation about Postpartum Depression, referral to treatment in the community, clinical monitoring
arm group label: Enhanced Treatment as Usual
other name: ETAU
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Catherine Monk, PhD
role: Principal Investigator
affiliation: Columbia University
last name: Elizabeth Werner, PhD
role: Study Director
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Catherine Monk
investigator title: Diana Vagelos Professor of Women's Mental Health (in Obstetrics and Gynecology and Psychiatry)
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Yes
ipd description: De-identified data may be made available to other researchers.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: After the completion of the study
ipd access criteria: Permission of the PI