Probabilistic Risk Modeling for Disorder Post Traumatic Stress (PTSD) After the Attacks in Paris In November 2015 (BV13)

June 22, 2017 updated by: WISSAM EL HAGE, University Hospital, Tours

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

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.

Study Overview

Status

Unknown

Detailed Description

cohort tracking study

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post traumatic disorder check list
Time Frame: 6 months after trauma
PTSD diagnose
6 months after trauma

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton depression scale
Time Frame: 6 months after trauma
personality
6 months after trauma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

July 3, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 22, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-A00162-49
  • SC16-WEH/BV13 (Registry Identifier: Ref study CPP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress Disorders, Post-Traumatic

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