Status:
UNKNOWN
Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Post-traumatic Stress Disorder (PTSD)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to assess if an early therapeutic management focused on the mother-baby interaction using Interaction Guidance Therapy (IGT) with video feedback, brings an improvement of the ...
Detailed Description
The investigators will compare the efficacy of Interactive Guidance Therapy, a parent-infant psychotherapy using video feed back versus a dyadic treatment conduct as usual (TAU) in women who present a...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- For the mother:
- Mother over 18 years old, who gave birth to a healthy child
- Mother having a PCL-5 score higher than \> 31, 5 +/- 1 week after delivery and the traumatic event is related to childbirth or pregnancy.
- Mother Speaking and reading French,
- Mother with signed consent
- Mother with rights open to social security
- Mother and Father consent to the participation of the baby
- For the father:
- holder of parental authority
- Speaking and reading French
- Consent to self-reported questionnaires
- Exclusion Criteria
- PTSD not related to pregnancy or birth.
- Child's health situation who impact the feasibility of the protocol, with a risk of hospitalization of more than 3 days between 6 and 12 weeks of life
- Childbirth under 34 weeks of gestational age
- Twins
- Stillbirth
- Any mother's acute, somatic or psychiatric clinical condition not compatible with the research procedure
Exclusion
Key Trial Info
Start Date :
December 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04916938
Start Date
December 29 2021
End Date
December 1 2024
Last Update
November 1 2022
Active Locations (10)
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1
CHU Besançon
Besançon, France, 25 000
2
CHU - Maternité
Besançon, France, 25000
3
Centre hospitalier Intercommunal André Grégoire
Montreuil, France, 93100
4
Etablissement Ville Evrard
Noisy-le-Sec, France, 93130