Postpartum DepressionppdNCT03791021
Early Diagnosis of PPD Through Self-portraits
An observational study of Postpartum Depression, run by Sheba Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- draw a person (DAP), Edinburgh Postnatal Depression Scale (EPDS) and Beck Depression Inventory- II (BDI-II)
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2019to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: 100 pregnant women
Who may be able to join
- third trimester pregnant women
Who cannot join
- pregnant women with established diagnosis of mental disorders
- still birth or intra uterine disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Postpartum Depression
- Being tested
- draw a person (DAP), Edinburgh Postnatal Depression Scale (EPDS), Beck Depression Inventory- II (BDI-II), Traumatic Events Questionnaire (TEQ)
- Keywords
- postpartum, depression, self portraits
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
draw a person (DAP)Diagnostic test
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.
Edinburgh Postnatal Depression Scale (EPDS)Diagnostic test
measure of postpartum depression symptoms.
Beck Depression Inventory- II (BDI-II)Diagnostic test
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.
Traumatic Events Questionnaire (TEQ)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: draw a person (DAP); Diagnostic Test: Edinburgh Postnatal Depression Scale (EPDS); Diagnostic Test: Beck Depression Inventory- II (BDI-II); Diagnostic Test: Traumatic Events Questionnaire (TEQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of a reliable projective tool for prediction of PPD
ratification of a projective tool using self portrait tests to identify patient at risk for developing PPD
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start1 Jan 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- University of Haifa
- Responsible party
- Principal investigator, Dr. Aya Mohr-Sasson, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791021
- Sponsor's protocol ID
- 5651-18-SMC
- Acronym
- ppd
- Status last verified
- Jun 2020
- First submitted
- 29 Dec 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Postpartum Depression Predicting Tool, During the Third Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT03791021
- Acronym / sponsor ID
- ppd / 5651-18-SMC
- Conditions
- Postpartum Depression
- Keywords
- postpartum, depression, self portraits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- University of Haifa
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| third trimester pregnant women | – | Diagnostic Test: draw a person (DAP), Diagnostic Test: Edinburgh Postnatal Depression Scale (EPDS), Diagnostic Test: Beck Depression Inventory- II (BDI-II), Diagnostic Test: Traumatic Events Questionnaire (TEQ)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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 100 pregnant women
Key inclusion criteria (1 listed)
- third trimester pregnant women
Key exclusion criteria (2 listed)
- pregnant women with established diagnosis of mental disorders
- still birth or intra uterine disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| draw a person (DAP)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. | Diagnostic test | third trimester pregnant women |
| Edinburgh Postnatal Depression Scale (EPDS)measure of postpartum depression symptoms. | Diagnostic test | third trimester pregnant women |
| Beck Depression Inventory- II (BDI-II)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. | Diagnostic test | third trimester pregnant women |
| Traumatic Events Questionnaire (TEQ)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. | Diagnostic test | third trimester pregnant women |
Primary outcome
development of a reliable projective tool for prediction of PPD
Time frame: one year
ratification of a projective tool using self portrait tests to identify patient at risk for developing PPD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of a reliable projective tool for prediction of PPD (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.