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serene: Post-natal Depression and Chronic Stress

Sponsor
Institut de Recherche Biomedicale des Armees (Other)
Overall Status
Completed
CT.gov ID
NCT03088319
Collaborator
(none)
100
Enrollment
1
Location
30
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Chronic Stress Protection for Post-natal Depression Prevention: An Exploratory Study
    Actual Study Start Date :
    Apr 11, 2017
    Actual Primary Completion Date :
    Oct 11, 2019
    Actual Study Completion Date :
    Oct 11, 2019

    Outcome Measures

    Primary Outcome Measures

    1. post natal depression [baseline at three 3 months of pregnancy and two months after labour delivery]

      change in Edimbourg Post-Partum Depression scale at two months after labour delivery

    Secondary Outcome Measures

    1. allostatic load as a composite index including blood GABA, BDNF and 8iso-Prostaglandins and capillary cortisol + heart rate variability index [baseline at three 3 months of pregnancy and two months after labour delivery]

      change in allostatic load two months after labour delivery

    Other Outcome Measures

    1. psychological functioning as a composite index including well-being, and stress control [baseline at three 3 months of pregnancy and two months after labour delivery]

      change in psychological functioning two months after labour delivery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marion Trousselard Brétigny-sur-Orge Not In US/Canada France 91223

    Sponsors and Collaborators

    • Institut de Recherche Biomedicale des Armees

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marion Trousselard, senior researcher, Institut de Recherche Biomedicale des Armees
    ClinicalTrials.gov Identifier:
    NCT03088319
    Other Study ID Numbers:
    • 2016-A00887-44
    First Posted:
    Mar 23, 2017
    Last Update Posted:
    Feb 12, 2020
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marion Trousselard, senior researcher, Institut de Recherche Biomedicale des Armees
    postnatal depression stress mindfulness allostatic load
    Additional relevant MeSH terms:
    Depression, Postpartum
    Depression
    Depressive Disorder

    Study Results

    No Results Posted as of Feb 12, 2020