- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02853513
Probabilistic Risk Modeling for Disorder Post Traumatic Stress (PTSD) After the Attacks in Paris In November 2015 (BV13)
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
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
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