Probabilistic Risk Modeling for Disorder Post Traumatic Stress (PTSD) After the Attacks in Paris In November 2015

Stress Disorders, Post-Traumatic Clinical Trial

— BV13  

Official title:

Definition of a Probabilistic Model of the Evolution of an Acute Stress Disorder (ASD ) to a Posttraumatic Stress Disorder (PTSD): an Analytical Prospective Cohort Study of Patients Directly Involved in Attacks Terrorists of 13 November 2015

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02853513
• Other study ID #: 2016-A00162-49
• Secondary ID: SC16-WEH/BV13
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 3, 2016
• Last updated: June 22, 2017
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: June 2017
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The scientific approach of this project proposes to build a cohort of "psychological injuries" post-attack of 13 November 2015. This is called patients "involved", ie patients who directly witnessed the events and having the most either came under automatic gunfire or were close to an explosion, whether or not physically injured.

The main objective is to define and validate a model of transition from acute stress disorder (ASD) to posttraumatic stress disorder (PTSD) for better detection of the risk of unfavorable and thus better patient supported.

The first step is to determine independent risk factors found in analytic prospective cohort study.

Bayesian models are well suited to exercise because they can integrate (i) the context related to the patient, (ii) the context related to the trauma itself, and (iii) the immediate reactions and long-term to the latter . They are particularly suited to understanding the brain disordered by saying down information (prior probability) wrong by improper memory of the traumatic event. The confrontation of these descending information and perceived bottom-information could be partly responsible for the symptoms of PTSD.

Once validated, the model will characterize the individual level the most at risk of unfavorable patients (calculating a probability of developing PTSD) and to assess the epidemiological impact on long-term cohort of event considered.

These determinations are necessary prerequisites to optimize the means of support for these current and future casualties.

The investigators main objective is to define a Bayesian model describing a resilient functioning facing a trauma which also allows to describe a possible evolution of the ASD to PTSD by an error.

The state of PTSD or not will be determined by the PCL-S scale.

Description:

cohort tracking study

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who directly witnessed the events and having the most either came under automatic gunfire or were close to an explosion, whether or not physically injured

Exclusion Criteria:

• persons not physically present on the premises at the time of the attacks.

• Inability to understand or read French.

• Persons unable to express personal consent under whose major legal or private protection of liberty by judicial or administrative decision , or hospital emergency or without their consent

Related Conditions & MeSH terms

• Disease
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Tours	Assistance Publique - Hôpitaux de Paris, University of Lorraine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post traumatic disorder check list	PTSD diagnose	6 months after trauma
Secondary	Hamilton depression scale	personality	6 months after trauma