<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/NCT03027037</url>
  </required_header>
  <id_info>
    <org_study_id>49683</org_study_id>
    <nct_id>NCT03027037</nct_id>
  </id_info>
  <brief_title>Perinatal Emotion and Relationships Longitudinal Study</brief_title>
  <acronym>PEARLS</acronym>
  <official_title>Perinatal Emotion and Relationships Longitudinal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Boulder</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>John Templeton Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Boulder</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>
      This study, funded by the John Templeton Foundation, will examine birth and the early&#xD;
      postpartum period (BEPP) as a transformative life experience that may shift women's&#xD;
      experience of emotion in such ways as to a) support enhanced other-oriented emotions and b)&#xD;
      underlie risk or resilience from psychopathology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specifically, the study will investigate the extent to which women can accurately have&#xD;
      knowledge about and predict changes in self- and other-oriented emotion processes associated&#xD;
      with BEPP. The investigators will also characterize the extent to which BEPP changes self-&#xD;
      and other-oriented emotion processes and self- and other-oriented social behaviors. Further,&#xD;
      the investigators will identify distinct trajectories of change in cognitive processes and&#xD;
      self- and other-oriented emotion processes related to BEPP, and examine how those&#xD;
      trajectories are associated with psychological adjustment (e.g., risk and relapse of&#xD;
      psychopathology). Finally, the investigators will identify which particular features of BEPP&#xD;
      are related to distinct patterns of change in self- and other-oriented emotion processes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of mood episodes and anxiety disorders</measure>
    <time_frame>Throughout study (pregnancy to 6 months postpartum)</time_frame>
    <description>Assessed via interview</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mood and anxiety symptoms</measure>
    <time_frame>Throughout study (pregnancy to 6 months postpartum)</time_frame>
    <description>Assessed via questionnaires</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotion reactivity and regulation</measure>
    <time_frame>Throughout study (pregnancy to 6 months postpartum)</time_frame>
    <description>Assessed via questionnaires, experimental tasks, and physiological measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Empathic accuracy</measure>
    <time_frame>Throughout study (pregnancy to 6 months postpartum)</time_frame>
    <description>Assessed via experimental tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prosocial behavior</measure>
    <time_frame>Throughout study (pregnancy to 6 months postpartum)</time_frame>
    <description>Assessed via questionnaires and experimental tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Well-being and social support</measure>
    <time_frame>Throughout study (pregnancy to 6 months postpartum)</time_frame>
    <description>Assessed via questionnaires</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting sensitivity, efficacy, stress, bond with infant</measure>
    <time_frame>Throughout study (pregnancy to 6 months postpartum)</time_frame>
    <description>Assessed via questionnaires and behavioral observation</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Depression, Postpartum</condition>
  <arm_group>
    <arm_group_label>Remitted Major Depression Group</arm_group_label>
    <description>Women in this group will have experienced at least one episode of major depression in their lifetime, but no episodes in the two months prior to study enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Women in this group will never have experienced any Diagnostic and Statistical Manual of Mental Disorders, 5th Edition Axis I psychological disorder.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include up to 200 pregnant adult women over the age of 18 across the United&#xD;
        States. Two roughly equal groups of participants will be recruited: women with a history of&#xD;
        major depressive disorder, currently in remission (MDD) and healthy controls with no&#xD;
        current or lifetime history of mental illness (CTL).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over age 18&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Currently pregnant - approximately no more than 34 weeks gestational age&#xD;
&#xD;
          -  Able to read and write in English fluently&#xD;
&#xD;
          -  MDD Group: Meet DSM-IV/DSM-5 criteria for at least 1 past episode of Major Depressive&#xD;
             Disorder&#xD;
&#xD;
          -  MDD Group: DO NOT meet DSM-IV/DSM-5 criteria for any episodes of Major Depressive&#xD;
             Disorder in past 2 months (currently in symptom remission)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous birth to a living child (i.e., this pregnancy is not their first child)&#xD;
&#xD;
          -  Imminently suicidal or homicidal&#xD;
&#xD;
          -  History of severe head trauma, stroke, neurological disease&#xD;
&#xD;
          -  History of brain tumors or surgery&#xD;
&#xD;
          -  Severe medical illness (e.g., autoimmune disorder, blindness, cardiovascular disease,&#xD;
             HIV/AIDS)&#xD;
&#xD;
          -  Endocrine disorders (e.g., Cushing's disease, thyroid disorder)&#xD;
&#xD;
          -  Alcohol/substance abuse or dependence within the past six months&#xD;
&#xD;
          -  Current psychotic episode (impairing ability to consent, participate, or keep patient&#xD;
             and experimenter safe)&#xD;
&#xD;
          -  Inability to follow study procedures&#xD;
&#xD;
          -  CTL Group: Current or lifetime Axis I disorder (i.e., anxiety disorders, major&#xD;
             depression, mania/hypomania, dysthymia, schizophrenia, schizoaffective disorder,&#xD;
             substance abuse/dependence, eating disorders, hypochondriasis, pain disorder, or&#xD;
             adjustment disorders)&#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>Sona Dimidjian, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Boulder</affiliation>
  </overall_official>
  <overall_official>
    <last_name>June Gruber, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Boulder</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Boulder</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>March 27, 2020</last_update_submitted>
  <last_update_submitted_qc>March 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Colorado, Boulder</investigator_affiliation>
    <investigator_full_name>Sona Dimidjian</investigator_full_name>
    <investigator_title>Professor and Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</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/NCT03027037
org study id: 49683
nct id: NCT03027037
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study, funded by the John Templeton Foundation, will examine birth and the early
      postpartum period (BEPP) as a transformative life experience that may shift women's
      experience of emotion in such ways as to a) support enhanced other-oriented emotions and b)
      underlie risk or resilience from psychopathology.
Specifically, the study will investigate the extent to which women can accurately have
      knowledge about and predict changes in self- and other-oriented emotion processes associated
      with BEPP. The investigators will also characterize the extent to which BEPP changes self-
      and other-oriented emotion processes and self- and other-oriented social behaviors. Further,
      the investigators will identify distinct trajectories of change in cognitive processes and
      self- and other-oriented emotion processes related to BEPP, and examine how those
      trajectories are associated with psychological adjustment (e.g., risk and relapse of
      psychopathology). Finally, the investigators will identify which particular features of BEPP
      are related to distinct patterns of change in self- and other-oriented emotion processes.
observational model: Cohort
time perspective: Prospective
measure: Occurrence of mood episodes and anxiety disorders
time frame: Throughout study (pregnancy to 6 months postpartum)
description: Assessed via interview
measure: Mood and anxiety symptoms
time frame: Throughout study (pregnancy to 6 months postpartum)
description: Assessed via questionnaires
measure: Emotion reactivity and regulation
time frame: Throughout study (pregnancy to 6 months postpartum)
description: Assessed via questionnaires, experimental tasks, and physiological measurement
measure: Empathic accuracy
time frame: Throughout study (pregnancy to 6 months postpartum)
description: Assessed via experimental tasks
measure: Prosocial behavior
time frame: Throughout study (pregnancy to 6 months postpartum)
description: Assessed via questionnaires and experimental tasks
measure: Well-being and social support
time frame: Throughout study (pregnancy to 6 months postpartum)
description: Assessed via questionnaires
measure: Parenting sensitivity, efficacy, stress, bond with infant
time frame: Throughout study (pregnancy to 6 months postpartum)
description: Assessed via questionnaires and behavioral observation
arm group label: Remitted Major Depression Group
description: Women in this group will have experienced at least one episode of major depression in their lifetime, but no episodes in the two months prior to study enrollment.
arm group label: Control Group
description: Women in this group will never have experienced any Diagnostic and Statistical Manual of Mental Disorders, 5th Edition Axis I psychological disorder.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sona Dimidjian, PhD
role: Principal Investigator
affiliation: University of Colorado, Boulder
last name: June Gruber, PhD
role: Principal Investigator
affiliation: University of Colorado, Boulder
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Colorado, Boulder
investigator full name: Sona Dimidjian
investigator title: Professor and Director
mesh term: Depression, Postpartum
sharing ipd: No