Post-natal Depression and Chronic Stress (serene)

Chronic Stress Protection for Post-natal Depression Prevention: An Exploratory Study

The risk of emergence of a post natal depression is based on an interaction between a maternal psychic vulnerability and a chronic environmental context of stress. The PND appears as a relevant model for studying the mechanisms of chronic stress and vulnerability to psychological pathologies.

This study aim to follow a cohort of pregnant women to determine the predictive psychobiological factors of the emergence of postnatal depression

Study Overview

• Status: Completed
• Conditions: Depression, Postpartum

Detailed Description

The prevalence of postnatal depression is high in civilian settings (20%). In mechanistic terms, the risk of emergence of a post natal depression is based on an interaction between a maternal psychic vulnerability and a chronic environmental context of stress. The post natal depression appears as a relevant model for studying the mechanisms of chronic stress and vulnerability to psychological pathologies.

• On the one hand, the repetition of stressors during pregnancy corresponds to a natural chronic stress model of several months and thus allows to study the biological cost of responses to repeated stresses, and the adaptive mechanisms leading to From functional drift to psychic dysfunction.
• On the other hand, isolated vulnerability factors characterize a mirroring psychological profile of a Mindfulness type of functioning. Mindfulness or full consciousness has been described as a state of consciousness which results from intentionally, at the present moment, without judging the experience that unfolds moment by moment. This psychological resource has been associated with resilient or even resilient psychic functioning.

This study aim to follow a cohort of pregnant women from the first trimester of pregnancies to 2 months after the delivery to determine the predictive psychobiological factors of the emergence of postnatal depression

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Not In US/Canada
    • Brétigny-sur-Orge, Not In US/Canada, France, 91223
      • Marion Trousselard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

WOMEN DURING EARLY PREGNANCY

Description

Inclusion Criteria:

• Physiological pregnancy
• Follow-up of pregnancy in a participating maternity
• Female over 18 years
• Affiliated to a social security scheme

Exclusion Criteria:

• Multiple pregnancy
• Psychiatric, neurological, or endocrine or autoimmune diseases
• Hormonal or psychotropic treatments

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post natal depression	change in Edimbourg Post-Partum Depression scale at two months after labour delivery	baseline at three 3 months of pregnancy and two months after labour delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
allostatic load as a composite index including blood GABA, BDNF and 8iso-Prostaglandins and capillary cortisol + heart rate variability index	change in allostatic load two months after labour delivery	baseline at three 3 months of pregnancy and two months after labour delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
psychological functioning as a composite index including well-being, and stress control	change in psychological functioning two months after labour delivery	baseline at three 3 months of pregnancy and two months after labour delivery

Collaborators and Investigators

• Sponsor: Institut de Recherche Biomedicale des Armees

Publications and helpful links

General Publications

• Tharwat D, Trousselard M, Bales M, Sutter-Dallay AL, Fromage D, Spitz E, Dallay D, Harvey T, Welter E, Coatleven F, Cherier L, Teissedre F, Pouly JL, Dutheil F, Duffaud AM. Chronic Stress protection for postnatal dEpREssioN prEvention (SERENE): a protocol for an exploratory study. BMJ Open. 2018 May 3;8(5):e018317. doi: 10.1136/bmjopen-2017-018317.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Actual): October 11, 2019
• Study Completion (Actual): October 11, 2019

Study Registration Dates

• First Submitted: March 11, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: postnatal depression stress mindfulness allostatic load
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 2016-A00887-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No