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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04516668
Other study ID # APHP200878
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2020
Est. completion date November 2020

Study information

Verified date July 2020
Source Assistance Publique - Hôpitaux de Paris
Contact Florence Gressier, Dr
Phone 01 45 21 27 43
Email florence.gressier@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Women 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date November 2020
Est. primary completion date November 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 BicĂȘtre 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 Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of Hospital anxiety and depression scale (HAD) 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 Evaluation of Edinburgh Postpartum Depression Scale (EPDS) 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
Secondary Evaluation of HAD score in fathers Anxiety and depression of fathers will be assessed with HAD scale 15 minutes
Secondary Evaluation of EPDS in fathers EPDS will be assessed in fathers who have a child of less than 2 years old 15 minutes
Secondary Study of the relationship between maternals and paternals symptoms The aim is to show that maternals anxious and depressive symptoms would be correlated to paternals positively symptoms 15 minutes
Secondary Study of difficuties in child during the quarantine 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
Secondary Risk and protection factors Description of risk factors and protection factors setting up by the family during this quarantine period 15 minutes
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