<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/NCT03793569</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00007890</org_study_id>
    <nct_id>NCT03793569</nct_id>
  </id_info>
  <brief_title>Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?</brief_title>
  <official_title>Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey Medical Center</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 long-term goal of this study is to validate a simple and inexpensive intervention to&#xD;
      reduce the incidence and impact of Postpartum Depression (PPD). The central hypothesis is&#xD;
      that enhancing social support of new mothers specifically via an organized peer get-together&#xD;
      will decrease rates of postpartum depression. The rationale for the proposed research is that&#xD;
      even though PPD is common and risk factors for developing PPD are known, simple and&#xD;
      inexpensive interventions to prevent PPD need to be studied. Postpartum mothers will be&#xD;
      recruited for the study and randomized into control versus intervention group. The&#xD;
      intervention group will be placed in a peer discussion group. Incidence of PPD will be&#xD;
      tracked.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to a 2014 Cochrane Review, postpartum depression (PPD) is present in 13% of new&#xD;
      mothers by twelve weeks postpartum. Infant feeding, sleep routines, growth, and&#xD;
      socioemotional and cognitive development can be adversely affected by maternal PPD. These&#xD;
      negative effects can last into childhood. Previous studies have shown that strong social&#xD;
      support is protective against PPD. The 2014 Cochrane Review on this topic comments that&#xD;
      simple, inexpensive interventions to decrease rates of PPD are needed and that interventions&#xD;
      led by lay-people and done in groups may be helpful to decrease rates of PPD. More recent&#xD;
      studies focus on interventions for mothers already showing symptoms of postpartum depression,&#xD;
      not on preventing these symptoms from developing.&#xD;
&#xD;
      The proposed work is important, because it capitalizes on recommendations for future research&#xD;
      from the 2014 Cochrane Review on Psychosocial and Psychological Interventions for Preventing&#xD;
      Postpartum Depression. The proposed work is also innovative, because it involves a preventive&#xD;
      intervention from lay-people in a group setting, with new moms benefiting from each other. At&#xD;
      the completion of this project, it is our expectation that mothers in the intervention group&#xD;
      will have sustained decreased rates of PPD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 27, 2018</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</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>Control group and intervention group. Intervention group will participate in peer discussion group.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Risk of development of postpartum depression</measure>
    <time_frame>4-8 weeks postpartum</time_frame>
    <description>Edinburg Postnatal Depression Scale. Score 0-30. Score &gt; or = 10 considered greater risk of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Development of postpartum depression</measure>
    <time_frame>12 weeks postpartum</time_frame>
    <description>Edinburg Postnatal Depression Scale. Score 0-30. Score &gt; or = 10 considered greater risk of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Development of postpartum depression</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Edinburg Postnatal Depression Scale. Score 0-30. Score &gt; or = 10 considered greater risk of depression.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Postpartum Depression</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be recruited and asked to complete Edinburgh Postnatal Depression Scale (EPDS) at specific timepoints postpartum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be recruited, asked to complete Edinburgh Postnatal Depression Scale at specific timepoints postpartum, and attend a peer discussion group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer discussion group</intervention_name>
    <description>Subjects in the intervention group will be asked to attend one peer group between four and eight weeks postpartum. Peer groups will be expected to last approximately one hour. Each peer group will include 5-10 new mothers. A facilitator will be present for these groups, but the hope is to have mothers discuss with each other their postpartum experience and activities of their newborn at home.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women who deliver at the Hershey Medical Center&#xD;
&#xD;
          2. Postpartum women within first week after delivery&#xD;
&#xD;
          3. Women who are 18 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Postpartum women who delivered newborn before 35 0/7 gestational age.&#xD;
&#xD;
          2. Postpartum women whose newborn required any length of stay in the newborn intensive&#xD;
             care unit.&#xD;
&#xD;
          3. Postpartum women who do not speak English.&#xD;
&#xD;
          4. Postpartum women who are less than 18 years old.&#xD;
&#xD;
          5. Postpartum women who are unable to provide consent.&#xD;
&#xD;
          6. Postpartum women who were on antidepressant or antianxiety medication or undergoing&#xD;
             therapy for depression or anxiety during pregnancy or during postpartum&#xD;
             hospitalization.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brittany A Massare, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Milton S. Hershey Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>June 5, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>August 20, 2019</last_update_submitted>
  <last_update_submitted_qc>August 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Brittany Massare</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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>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/NCT03793569
org study id: STUDY00007890
nct id: NCT03793569
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The long-term goal of this study is to validate a simple and inexpensive intervention to
      reduce the incidence and impact of Postpartum Depression (PPD). The central hypothesis is
      that enhancing social support of new mothers specifically via an organized peer get-together
      will decrease rates of postpartum depression. The rationale for the proposed research is that
      even though PPD is common and risk factors for developing PPD are known, simple and
      inexpensive interventions to prevent PPD need to be studied. Postpartum mothers will be
      recruited for the study and randomized into control versus intervention group. The
      intervention group will be placed in a peer discussion group. Incidence of PPD will be
      tracked.
According to a 2014 Cochrane Review, postpartum depression (PPD) is present in 13% of new
      mothers by twelve weeks postpartum. Infant feeding, sleep routines, growth, and
      socioemotional and cognitive development can be adversely affected by maternal PPD. These
      negative effects can last into childhood. Previous studies have shown that strong social
      support is protective against PPD. The 2014 Cochrane Review on this topic comments that
      simple, inexpensive interventions to decrease rates of PPD are needed and that interventions
      led by lay-people and done in groups may be helpful to decrease rates of PPD. More recent
      studies focus on interventions for mothers already showing symptoms of postpartum depression,
      not on preventing these symptoms from developing.

      The proposed work is important, because it capitalizes on recommendations for future research
      from the 2014 Cochrane Review on Psychosocial and Psychological Interventions for Preventing
      Postpartum Depression. The proposed work is also innovative, because it involves a preventive
      intervention from lay-people in a group setting, with new moms benefiting from each other. At
      the completion of this project, it is our expectation that mothers in the intervention group
      will have sustained decreased rates of PPD.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Control group and intervention group. Intervention group will participate in peer discussion group.
primary purpose: Prevention
masking: None (Open Label)
measure: Risk of development of postpartum depression
time frame: 4-8 weeks postpartum
description: Edinburg Postnatal Depression Scale. Score 0-30. Score > or = 10 considered greater risk of depression.
measure: Development of postpartum depression
time frame: 12 weeks postpartum
description: Edinburg Postnatal Depression Scale. Score 0-30. Score > or = 10 considered greater risk of depression.
measure: Development of postpartum depression
time frame: 6 months postpartum
description: Edinburg Postnatal Depression Scale. Score 0-30. Score > or = 10 considered greater risk of depression.
arm group label: Control group
arm group type: No Intervention
description: Participants will be recruited and asked to complete Edinburgh Postnatal Depression Scale (EPDS) at specific timepoints postpartum.
arm group label: Intervention group
arm group type: Experimental
description: Participants will be recruited, asked to complete Edinburgh Postnatal Depression Scale at specific timepoints postpartum, and attend a peer discussion group.
intervention type: Behavioral
intervention name: Peer discussion group
description: Subjects in the intervention group will be asked to attend one peer group between four and eight weeks postpartum. Peer groups will be expected to last approximately one hour. Each peer group will include 5-10 new mothers. A facilitator will be present for these groups, but the hope is to have mothers discuss with each other their postpartum experience and activities of their newborn at home.
arm group label: Intervention group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Brittany A Massare, MD
role: Principal Investigator
affiliation: Milton S. Hershey Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Brittany Massare
investigator title: Principal Investigator
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No