Effect of Tele-consultation in Addition With Psychiatric Follow-up During COVID-19 in Women Who Have Medical History of Post-partum Depression

Post Partum Depression Clinical Trial

— COVIDDEPERINAT  

Official title:

Survey About Anxious and Depressive Symptoms During COVID-19 in Women Who Have Medical History of Post-partum Depression: Interest of Tele-consultation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04516668
• Other study ID #: APHP200878
• Status: Not yet recruiting
• 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
• 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 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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post Partum Depression

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