<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/NCT03791021</url>
  </required_header>
  <id_info>
    <org_study_id>5651-18-SMC</org_study_id>
    <nct_id>NCT03791021</nct_id>
  </id_info>
  <brief_title>Early Diagnosis of PPD Through Self-portraits</brief_title>
  <acronym>ppd</acronym>
  <official_title>Developing a Postpartum Depression Predicting Tool, During the Third Trimester of Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Haifa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheba 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 target of the research is development of a predictive tool for early identification of&#xD;
      women which are at higher risk for development of postpartum depression.&#xD;
&#xD;
      the evaluating tools include self portraits and questionnaire during the third trimester of&#xD;
      pregnancy.&#xD;
&#xD;
      The suggested research aims to evaluate if and how it would be possible to predict the&#xD;
      potential for postpartum mood swing disorders in pregnant women while in the third trimester.&#xD;
      The later to prevent the mother from enduring such a detrimental experience, which influences&#xD;
      the child development, the family as well as the mother's intimate relationship.&#xD;
&#xD;
      The aim is to identify indicators to predict such potential, using questionnaires and&#xD;
      self-portraits during pregnancy, to allow early intervention and treatment. Early diagnosis&#xD;
      and quick treatment of pregnant women or post-partum mothers will allow them a higher level&#xD;
      of functioning and may even prevent eventually infant neurological and developmental delays&#xD;
      and hardships.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the target of the research is to evaluate a method based on self portraits and targeted&#xD;
      questionnaire done in the third trimester and three months later in order to identify&#xD;
      pregnant women in higher risk to develop PPD.&#xD;
&#xD;
      the minimal number of objectives participating in the research would be 100 pregnant women&#xD;
      during the third trimester of pregnancy.&#xD;
&#xD;
      the Draw A Person (DAP) test was described by Machover in 1949. it is still considered a&#xD;
      reliable and well recognized test for evaluation of mental stress and disorders (Gilory,&#xD;
      2012).&#xD;
&#xD;
      in the research approximately 100 pregnant women in the third trimester would be asked to&#xD;
      draw a self portrait in two different time points (during the third trimester and three to&#xD;
      six months postpartum). in addition to the self portraits the participants would be asked to&#xD;
      fill a set of questionnaires to evaluate the degree of depression, self esteem, personal&#xD;
      history of traumatic events, and demographic data.&#xD;
&#xD;
      the self portraits would be evaluated by three judges. the reliability between judges would&#xD;
      be tested using KAPPA test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>development of a reliable projective tool for prediction of PPD</measure>
    <time_frame>one year</time_frame>
    <description>ratification of a projective tool using self portrait tests to identify patient at risk for developing PPD</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Postpartum Depression</condition>
  <arm_group>
    <arm_group_label>third trimester pregnant women</arm_group_label>
    <description>the group of participants in this research would include approximately 100 subjects in the third trimester of their pregnancy. the participants would be collected in the central area of Israel from various socioeconomic groups. each participant would be asked to make draw a person (DAP) test, and answer a number of questionnaires including Edinburgh Postnatal Depression Scale (EPDS), Beck Depression Inventory II (BDI-II), and Traumatic Events Questionnaire (TEQ).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>draw a person (DAP)</intervention_name>
    <description>the subjects will be given a blank sheet of white paper and a pencil, and will be asked to draw themselves with no other additional instructions.</description>
    <arm_group_label>third trimester pregnant women</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Edinburgh Postnatal Depression Scale (EPDS)</intervention_name>
    <description>measure of postpartum depression symptoms.</description>
    <arm_group_label>third trimester pregnant women</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Beck Depression Inventory- II (BDI-II)</intervention_name>
    <description>BDI-II is based on clinical observations of behaviors associated with depression, and it retains the somatic items in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria related to loss of energy. ansd sleep disturbances.</description>
    <arm_group_label>third trimester pregnant women</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Traumatic Events Questionnaire (TEQ)</intervention_name>
    <description>The TEQ assesses experiences with nine specific types of traumatic events (e.g., accidents, crime, adult abusive experiences) reported in the empirical literature as having the potential to elicit PTSD symptoms.</description>
    <arm_group_label>third trimester pregnant women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        100 pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  third trimester pregnant women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women with established diagnosis of mental disorders&#xD;
&#xD;
          -  still birth or intra uterine disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Aya Mohr Sasson</name>
      <address>
        <city>Ramat -Gan</city>
        <state>Please Select</state>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>June 7, 2020</last_update_submitted>
  <last_update_submitted_qc>June 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Aya Mohr-Sasson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>postpartum, depression, self portraits</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>
  <!-- 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/NCT03791021
org study id: 5651-18-SMC
nct id: NCT03791021
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the target of the research is development of a predictive tool for early identification of
      women which are at higher risk for development of postpartum depression.

      the evaluating tools include self portraits and questionnaire during the third trimester of
      pregnancy.

      The suggested research aims to evaluate if and how it would be possible to predict the
      potential for postpartum mood swing disorders in pregnant women while in the third trimester.
      The later to prevent the mother from enduring such a detrimental experience, which influences
      the child development, the family as well as the mother's intimate relationship.

      The aim is to identify indicators to predict such potential, using questionnaires and
      self-portraits during pregnancy, to allow early intervention and treatment. Early diagnosis
      and quick treatment of pregnant women or post-partum mothers will allow them a higher level
      of functioning and may even prevent eventually infant neurological and developmental delays
      and hardships.
the target of the research is to evaluate a method based on self portraits and targeted
      questionnaire done in the third trimester and three months later in order to identify
      pregnant women in higher risk to develop PPD.

      the minimal number of objectives participating in the research would be 100 pregnant women
      during the third trimester of pregnancy.

      the Draw A Person (DAP) test was described by Machover in 1949. it is still considered a
      reliable and well recognized test for evaluation of mental stress and disorders (Gilory,
      2012).

      in the research approximately 100 pregnant women in the third trimester would be asked to
      draw a self portrait in two different time points (during the third trimester and three to
      six months postpartum). in addition to the self portraits the participants would be asked to
      fill a set of questionnaires to evaluate the degree of depression, self esteem, personal
      history of traumatic events, and demographic data.

      the self portraits would be evaluated by three judges. the reliability between judges would
      be tested using KAPPA test.
observational model: Case-Only
time perspective: Prospective
measure: development of a reliable projective tool for prediction of PPD
time frame: one year
description: ratification of a projective tool using self portrait tests to identify patient at risk for developing PPD
arm group label: third trimester pregnant women
description: the group of participants in this research would include approximately 100 subjects in the third trimester of their pregnancy. the participants would be collected in the central area of Israel from various socioeconomic groups. each participant would be asked to make draw a person (DAP) test, and answer a number of questionnaires including Edinburgh Postnatal Depression Scale (EPDS), Beck Depression Inventory II (BDI-II), and Traumatic Events Questionnaire (TEQ).
intervention type: Diagnostic Test
intervention name: draw a person (DAP)
description: the subjects will be given a blank sheet of white paper and a pencil, and will be asked to draw themselves with no other additional instructions.
arm group label: third trimester pregnant women
intervention type: Diagnostic Test
intervention name: Edinburgh Postnatal Depression Scale (EPDS)
description: measure of postpartum depression symptoms.
arm group label: third trimester pregnant women
intervention type: Diagnostic Test
intervention name: Beck Depression Inventory- II (BDI-II)
description: BDI-II is based on clinical observations of behaviors associated with depression, and it retains the somatic items in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria related to loss of energy. ansd sleep disturbances.
arm group label: third trimester pregnant women
intervention type: Diagnostic Test
intervention name: Traumatic Events Questionnaire (TEQ)
description: The TEQ assesses experiences with nine specific types of traumatic events (e.g., accidents, crime, adult abusive experiences) reported in the empirical literature as having the potential to elicit PTSD symptoms.
arm group label: third trimester pregnant women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Aya Mohr-Sasson
investigator title: Principal Investigator
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder