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

October 5, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Unknown

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

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Women who were treated by the psychiatry department at Bicêtre hospital for post-partum depression between 2013 and late 2019 and their partner

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Florence Gressier, Dr, Bicetre Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

July 1, 2020

More Information

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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