Post-traumatic Stress Disorder (PTSD) Clinical Trial
Official title:
Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress
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 maternal sensitivity in the interaction but also a decrease of the post-traumatic maternal symptoms. Post Natal Post traumatic stress is known as a disorder that impaired maternal mental health but also development of motherhood and the construction of the bond to the baby through interactive disturbances. The investigators will screen, among women who had a traumatic perception of an event related to the pregnancy or the childbirth, those who still present posttraumatic stress symptoms at 4 weeks post-partum. Four weeks from the traumatic event is the minimum delay to qualify a PTSD. After randomization IGT versus Treatment As Usual (TAU), the investigators planned an early therapeutic intervention, 3 sessions at 8, 10 and 12 weeks of post-partum. The investigators will assess the effect of the IGT on Maternal sensitivity and on the intensity of post-traumatic stress symptoms at 3 month post-partum and 1year.
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 post traumatic stress disorder related to childbirth or pregnancy. The main assessment is the maternal sensitivity, assessed during a video recorded free play interaction between the mother and the baby and rate with the Coding of interactive Behaviour (CIB). This is a Single Blind Randomized clinical trial. Only the rating of the (CIB), which is the primary end point, will be done blind for the treatment the dyad received. The randomization will proceed after the inclusion visit and the first assessment that take place at 6 weeks of post partum. The following assessments will take place at 4 months and 12 months. The investigators will conduct a national multicentre study with 5 inclusions centres, which are all child psychiatry unit specialized in perinatal period and already train or in training for the IGT method. - Pre-screening in post partum ward or during post partum consultation. - Pre Inclusion at 5 (+-1) weeks to assess PTSD with Post traumatic checklist (PCL -5) - Inclusion and First assessment at 6 weeks post partum - Randomization: 3 session of IGT or TAU at 8 weeks, 10 weeks and 12 weeks Assessment at 4 months (+/-2W) and 12 months (+/- 1M) ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT05189977 -
A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline
|
Phase 1 | |
Completed |
NCT01806168 -
rTMS in the Treatment of PTSD
|
N/A | |
Not yet recruiting |
NCT06194851 -
Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
|
Phase 2 | |
Completed |
NCT02187224 -
Progesterone Effect on Individuals Diagnoses With AD and PTSD.
|
Phase 2/Phase 3 | |
Completed |
NCT02549508 -
Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD
|
N/A | |
Completed |
NCT02012738 -
Treatment of Trauma and Violence in the Townships of South Africa
|
N/A | |
Not yet recruiting |
NCT01940549 -
Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy for Posttraumatic Stress Disorder
|
N/A | |
Not yet recruiting |
NCT06419959 -
NightWare and Cardiovascular Health in Veterans With PTSD
|
N/A | |
Terminated |
NCT03209882 -
Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Cognition in Post-traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT04891614 -
The PRISM Pilot Trial for Post-Traumatic Stress Disorder
|
N/A | |
Recruiting |
NCT05407337 -
The Effect of Narrative Exposure Therapy Intervention on Post-traumatic Stress Dissorder and Personal Recovery in Refugees and Asylum Seekers of Sindiane Programme
|
N/A | |
Completed |
NCT02030522 -
Prospective Cohort Study of Accelerated Resolution Therapy (ART) for Treatment of Military Psychological Trauma
|
N/A | |
Completed |
NCT01729325 -
Prevention of Post-Traumatic Stress Disorder in Soldiers
|
Phase 2 | |
Completed |
NCT02053532 -
Functional Brain Imaging in PTSD
|
N/A | |
Not yet recruiting |
NCT02598024 -
Treating Earthquake in Nepal Trauma (TENT) Trial 2016
|
N/A | |
Terminated |
NCT02237703 -
Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD)
|
N/A | |
Withdrawn |
NCT02356861 -
LED Light Therapy to Improve Cognitive & Psychosocial Function in TBI-PTSD Veterans
|
N/A | |
Not yet recruiting |
NCT05974631 -
Evaluating Treatments for Suicidal Veterans With PTSD
|
N/A | |
Not yet recruiting |
NCT06288594 -
TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability
|
N/A | |
Completed |
NCT01847469 -
Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
|
Phase 2 |