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

Sponsor
University Hospital, Tours (Other)
Overall Status
Unknown status
CT.gov ID
NCT02853513
Collaborator
Assistance Publique - Hôpitaux de Paris (Other), University of Lorraine (Other)
100
Enrollment
24
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    cohort tracking study

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Jul 1, 2016
    Actual Primary Completion Date :
    Nov 1, 2016
    Anticipated Study Completion Date :
    Jul 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Post traumatic disorder check list [6 months after trauma]

      PTSD diagnose

    Secondary Outcome Measures

    1. Hamilton depression scale [6 months after trauma]

      personality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Tours
    • Assistance Publique - Hôpitaux de Paris
    • University of Lorraine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    WISSAM EL HAGE, Professor, University Hospital, Tours
    ClinicalTrials.gov Identifier:
    NCT02853513
    Other Study ID Numbers:
    • 2016-A00162-49
    • SC16-WEH/BV13
    First Posted:
    Aug 3, 2016
    Last Update Posted:
    Jun 26, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Disease
    Stress Disorders, Traumatic
    Stress Disorders, Post-Traumatic

    Study Results

    No Results Posted as of Jun 26, 2017