- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04516668
Effect of Tele-consultation in Addition With Psychiatric Follow-up During COVID-19 in Women Who Have Medical History of Post-partum Depression (COVIDDEPERINAT)
Survey About Anxious and Depressive Symptoms During COVID-19 in Women Who Have Medical History of Post-partum Depression: Interest of Tele-consultation
Study Overview
Status
Conditions
Detailed Description
The pandemic of COVID-19 (coronavirus desease 19) led to a strict quarantine from 15 March 2020 to 11 May 2020. Maternal depression is a current pathology , especially in the post-partum (more than 15%). The quarantine could lead to anxious and/or depressive symptoms and difficulties in parents-children bonding.
Women who have experenced post-partum period have more chance to developp subsequent depression.
Among women who have experienced post-partum depression, those who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Florence Gressier, Dr
- Phone Number: 01 45 21 27 43
- Email: florence.gressier@aphp.fr
Study Contact Backup
- Name: Emmanuelle Corruble, Pr
- Phone Number: 01 45 21 27 43
- Email: emmanuelle.corruble@aphp.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Women above 18 years old
Who have experienced a post-partum depression between 2013 and late of 2019
Who have benefit a psychiatry post-partum follow-up (hospitalizations in psychiatry post-partum unity and/or medical consultation) by Bicêtre psychiatry service
Who have a child less than 7 years old (preschool age)
Speaking and reading in french
And their partner (above 18 years old)
In the main analyze, only women with a indication of following psychiatric follow-up by tele-consultation (with a psychiatric follow-up at the begenning of the quarantine, who have not been follow-up by psychiatrist in hospitalization or in face to face consultation) will be analyzed
Exclusion Criteria:
People with chronic psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders:DSM-5 criteria)
People with mental handicap
People who are not able to give their consent
People subject to protection measure
People refusing to participate in the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Hospital anxiety and depression scale (HAD)
Time Frame: 15 minutes
|
To compare depression and anxiety HAD score of women who have a medical history ofpost-partum depression according to a follow-up or not during the quarantine by tele-consultation Score less than or egal to 7 = no case Score between 8 and 10 = uncertain case Score higher than or equal to 11 = confirmed case |
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Edinburgh Postpartum Depression Scale (EPDS)
Time Frame: 15 minutes
|
To compare the result of EPDS in women who have a child of less 2 years old according to a follow-up or not by tele-consultation during the quarantine
|
15 minutes
|
Evaluation of HAD score in fathers
Time Frame: 15 minutes
|
Anxiety and depression of fathers will be assessed with HAD scale
|
15 minutes
|
Evaluation of EPDS in fathers
Time Frame: 15 minutes
|
EPDS will be assessed in fathers who have a child of less than 2 years old
|
15 minutes
|
Study of the relationship between maternals and paternals symptoms
Time Frame: 15 minutes
|
The aim is to show that maternals anxious and depressive symptoms would be correlated to paternals positively symptoms
|
15 minutes
|
Study of difficuties in child during the quarantine
Time Frame: 15 minutes
|
Look for a correlation between the difficulties in child during the quarantine describe by parents and anxiety and depression symptoms in parents The difficulties in child will be illustrated with the rate of children with difficulties describe by the parents
|
15 minutes
|
Risk and protection factors
Time Frame: 15 minutes
|
Description of risk factors and protection factors setting up by the family during this quarantine period
|
15 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Florence Gressier, Dr, Bicetre Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- Behavioral Symptoms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Mood Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Pregnancy Complications
- Puerperal Disorders
- Depression
- Depressive Disorder
- COVID-19
- Depression, Postpartum
Other Study ID Numbers
- APHP200878
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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