NCT02853513

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

4 months

First QC Date

July 3, 2016

Last Update Submit

June 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post traumatic disorder check list

    PTSD diagnose

    6 months after trauma

Secondary Outcomes (1)

  • Hamilton depression scale

    6 months after trauma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2016

First Posted

August 3, 2016

Study Start

July 1, 2016

Primary Completion

November 1, 2016

Study Completion

July 1, 2018

Last Updated

June 26, 2017

Record last verified: 2017-06