- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03791021
Early Diagnosis of PPD Through Self-portraits (ppd)
Developing a Postpartum Depression Predicting Tool, During the Third Trimester of Pregnancy
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Please Select
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Ramat -Gan, Please Select, Israel, 52621
- Aya Mohr Sasson
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- third trimester pregnant women
Exclusion Criteria:
- pregnant women with established diagnosis of mental disorders
- still birth or intra uterine disorders
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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third trimester pregnant women
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).
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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.
measure of postpartum depression symptoms.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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development of a reliable projective tool for prediction of PPD
Time Frame: one year
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ratification of a projective tool using self portrait tests to identify patient at risk for developing PPD
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one year
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5651-18-SMC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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