<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/NCT03011801</url>
  </required_header>
  <id_info>
    <org_study_id>MH109662</org_study_id>
    <nct_id>NCT03011801</nct_id>
  </id_info>
  <brief_title>Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms</brief_title>
  <official_title>Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Urbana-Champaign</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Urbana-Champaign</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>
      This study evaluates Interpersonal Therapy (IPT) in the treatment of depression among&#xD;
      pregnant women with elevated depressive symptoms. Half of the women will be randomized to&#xD;
      receive IPT, and the other half will get Treat As Usual, provided via behavioral health in&#xD;
      the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exposure to maternal depressive symptoms is one of the most well established risk factors for&#xD;
      the development of later child psychopathology. Accumulating evidence from naturalistic&#xD;
      observational studies documents that fetal exposure to maternal depressive symptoms is&#xD;
      associated with risk for later child mental health problems. Maternal depression is one of&#xD;
      the most common prenatal complications with approximately 40% of women experiencing elevated&#xD;
      levels of depressive symptoms. The majority of past research has been correlational, so&#xD;
      potential causal conclusions have been limited. This project will break new ground by testing&#xD;
      the hypothesis that manipulating maternal depressive symptoms will benefit infant outcomes.&#xD;
      In this project, maternal depressive symptoms will be reduced using brief interpersonal&#xD;
      therapy (IPT), a well-established and efficacious treatment, and testing whether this&#xD;
      reduction leads to an improvement in the development of infant mechanisms associated with&#xD;
      risk for later psychopathology. The investigators propose to assess 300 pregnant women who&#xD;
      report elevated levels of depressive symptoms and their infants. Prior to the intervention,&#xD;
      maternal measures of depressive symptoms will be collected. Then half of the women will be&#xD;
      randomized to receive IPT and the other half will receive enhanced usual care (TAU). After&#xD;
      completion of the intervention, maternal measures will be collected longitudinally through 14&#xD;
      months postpartum. Infants will be evaluated at birth and two other times. Infants will be&#xD;
      assessed across four units of analysis (brain structure and function, physiology, behavior,&#xD;
      and maternal-report).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 28, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of a Major Depressive Episode on SCID interview</measure>
    <time_frame>12 months post pregnancy</time_frame>
    <description>Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Checklist 20 (SCL20)</measure>
    <time_frame>post intervention (approximately 2-3 months post baseline)</time_frame>
    <description>Self reported Depression Scores. higher scores=more depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Checklist 20 (SCL20)</measure>
    <time_frame>6 months post intervention</time_frame>
    <description>Self reported Depression Scores. higher scores=more depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Checklist 20 (SCL20)</measure>
    <time_frame>12 months post intervention</time_frame>
    <description>Self reported Depression Scores. higher scores=more depression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Edinburgh Postnatal Depression Scale (EPDS)</measure>
    <time_frame>post intervention (approximately 2-3 months post baseline)</time_frame>
    <description>Self reported Depression Scores. higher scores=more depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Edinburgh Postnatal Depression Scale (EPDS)</measure>
    <time_frame>6 months post intervention</time_frame>
    <description>Self reported Depression Scores. higher scores=more depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Edinburgh Postnatal Depression Scale (EPDS)</measure>
    <time_frame>12 months post intervention</time_frame>
    <description>Self reported Depression Scores. higher scores=more depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work and Social Adjustment Scale (WSAS)</measure>
    <time_frame>post intervention (approximately 2-3 months post baseline)</time_frame>
    <description>general maternal functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work and Social Adjustment Scale (WSAS)</measure>
    <time_frame>6 month post intervention</time_frame>
    <description>general maternal functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work and Social Adjustment Scale (WSAS)</measure>
    <time_frame>12 month post intervention</time_frame>
    <description>general maternal functioning</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Behavioral: Interpersonal Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individual psychotherapy that includes an initial engagement session and a total of 8 sessions. IPT focuses on psychoeducation and interpersonal skill building to decrease interpersonal conflict and increase interpersonal support and competence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maternity support services (MSS) is the usual standard of care for pregnant women. A multi-disciplinary team of obstetric care providers routinely screen women for possible depression diagnosis. If a woman screens positive, she is seen by a behavioral health specialist (BHS) for further assessment and to initiate treatment, if necessary. The goals of MSS include offering services to promote healthy pregnancies and positive birth and parenting outcomes, including integrating mental health and prenatal care. Women with elevated depressive symptoms are seen by BHS throughout the pregnancy and postpartum period and then bridged to mental health treatment. BHS provides eclectic-based care but does not provide IPT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interpersonal Therapy</intervention_name>
    <description>reducing conflict in relationships, increasing social support in relationships, improving communication, reducing depressive symptoms</description>
    <arm_group_label>Behavioral: Interpersonal Therapy</arm_group_label>
    <other_name>IPT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced usual care</intervention_name>
    <description>Treatment as Usual, including eclectic and supportive therapy, as well as psychiatric medication</description>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
    <other_name>Maternity Support Services (MSS)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult women (over 18 years of age)&#xD;
&#xD;
          -  A singleton intrauterine pregnancy&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Elevated depressive symptoms based on screening with the Edinburgh Postnatal&#xD;
             Depression Scale (EPDS) with score &gt; 9&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bipolar disorder and psychosis based on the Structured Clinical Interview for DSM-IV&#xD;
             Axis I Disorders (SCID-NP)&#xD;
&#xD;
          -  Current psychotropic medication use or current CBT/IPT usage&#xD;
&#xD;
          -  An HPA axis or an endocrine disorder&#xD;
&#xD;
          -  Maternal substance use [assessed using maternal report and urine toxicology&#xD;
&#xD;
          -  Corticosteroid medication use during this pregnancy&#xD;
&#xD;
          -  Invitto fertilization&#xD;
&#xD;
          -  Presence of cervical or uterine abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Benjamin L Hankin, PhD</last_name>
    <phone>217-300-9334</phone>
    <email>hankinb@illinois.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elysia Davis, PhD</last_name>
      <phone>303-871-3790</phone>
      <email>Elysia.Davis@du.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Illinois</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>February 10, 2021</last_update_submitted>
  <last_update_submitted_qc>February 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>NIMH Data Archive</ipd_description>
  </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/NCT03011801
org study id: MH109662
nct id: NCT03011801
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates Interpersonal Therapy (IPT) in the treatment of depression among
      pregnant women with elevated depressive symptoms. Half of the women will be randomized to
      receive IPT, and the other half will get Treat As Usual, provided via behavioral health in
      the hospital.
Exposure to maternal depressive symptoms is one of the most well established risk factors for
      the development of later child psychopathology. Accumulating evidence from naturalistic
      observational studies documents that fetal exposure to maternal depressive symptoms is
      associated with risk for later child mental health problems. Maternal depression is one of
      the most common prenatal complications with approximately 40% of women experiencing elevated
      levels of depressive symptoms. The majority of past research has been correlational, so
      potential causal conclusions have been limited. This project will break new ground by testing
      the hypothesis that manipulating maternal depressive symptoms will benefit infant outcomes.
      In this project, maternal depressive symptoms will be reduced using brief interpersonal
      therapy (IPT), a well-established and efficacious treatment, and testing whether this
      reduction leads to an improvement in the development of infant mechanisms associated with
      risk for later psychopathology. The investigators propose to assess 300 pregnant women who
      report elevated levels of depressive symptoms and their infants. Prior to the intervention,
      maternal measures of depressive symptoms will be collected. Then half of the women will be
      randomized to receive IPT and the other half will receive enhanced usual care (TAU). After
      completion of the intervention, maternal measures will be collected longitudinally through 14
      months postpartum. Infants will be evaluated at birth and two other times. Infants will be
      assessed across four units of analysis (brain structure and function, physiology, behavior,
      and maternal-report).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Presence of a Major Depressive Episode on SCID interview
time frame: 12 months post pregnancy
description: Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation
measure: Symptom Checklist 20 (SCL20)
time frame: post intervention (approximately 2-3 months post baseline)
description: Self reported Depression Scores. higher scores=more depression
measure: Symptom Checklist 20 (SCL20)
time frame: 6 months post intervention
description: Self reported Depression Scores. higher scores=more depression
measure: Symptom Checklist 20 (SCL20)
time frame: 12 months post intervention
description: Self reported Depression Scores. higher scores=more depression
measure: Edinburgh Postnatal Depression Scale (EPDS)
time frame: post intervention (approximately 2-3 months post baseline)
description: Self reported Depression Scores. higher scores=more depression
measure: Edinburgh Postnatal Depression Scale (EPDS)
time frame: 6 months post intervention
description: Self reported Depression Scores. higher scores=more depression
measure: Edinburgh Postnatal Depression Scale (EPDS)
time frame: 12 months post intervention
description: Self reported Depression Scores. higher scores=more depression
measure: Work and Social Adjustment Scale (WSAS)
time frame: post intervention (approximately 2-3 months post baseline)
description: general maternal functioning
measure: Work and Social Adjustment Scale (WSAS)
time frame: 6 month post intervention
description: general maternal functioning
measure: Work and Social Adjustment Scale (WSAS)
time frame: 12 month post intervention
description: general maternal functioning
arm group label: Behavioral: Interpersonal Therapy
arm group type: Experimental
description: Individual psychotherapy that includes an initial engagement session and a total of 8 sessions. IPT focuses on psychoeducation and interpersonal skill building to decrease interpersonal conflict and increase interpersonal support and competence.
arm group label: Enhanced Usual Care
arm group type: Placebo Comparator
description: Maternity support services (MSS) is the usual standard of care for pregnant women. A multi-disciplinary team of obstetric care providers routinely screen women for possible depression diagnosis. If a woman screens positive, she is seen by a behavioral health specialist (BHS) for further assessment and to initiate treatment, if necessary. The goals of MSS include offering services to promote healthy pregnancies and positive birth and parenting outcomes, including integrating mental health and prenatal care. Women with elevated depressive symptoms are seen by BHS throughout the pregnancy and postpartum period and then bridged to mental health treatment. BHS provides eclectic-based care but does not provide IPT.
intervention type: Behavioral
intervention name: Interpersonal Therapy
description: reducing conflict in relationships, increasing social support in relationships, improving communication, reducing depressive symptoms
arm group label: Behavioral: Interpersonal Therapy
other name: IPT
intervention type: Behavioral
intervention name: Enhanced usual care
description: Treatment as Usual, including eclectic and supportive therapy, as well as psychiatric medication
arm group label: Enhanced Usual Care
other name: Maternity Support Services (MSS)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin L Hankin, PhD
phone: 217-300-9334
email: hankinb@illinois.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Enrolling by invitation
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Yes
ipd description: NIMH Data Archive