Stress Disorders, Post-TraumaticBV13NCT02853513
Probabilistic Risk Modeling for Disorder Post Traumatic Stress (PTSD) After the Attacks in Paris In November 2015
An observational study of Stress Disorders, Post-Traumatic, run by University Hospital, Tours.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read more
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.
Read the detailed description
cohort tracking study
- Conditions
- Stress Disorders, Post-Traumatic
- Medical subject headings
- Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Post traumatic disorder check list
PTSD diagnose
Measured: 6 months after trauma
Secondary outcomes (1)
Hamilton depression scale
personality
Measured: 6 months after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, University of Lorraine
- Responsible party
- Principal investigator, WISSAM EL HAGE, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853513
- Sponsor's protocol ID
- 2016-A00162-49
- Other IDs
- SC16-WEH/BV13
- Acronym
- BV13
- Status last verified
- Jun 2017
- First submitted
- 3 Jul 2016
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02853513
- Acronym / sponsor ID
- BV13 / 2016-A00162-49
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, University of Lorraine
- Study start
- Jul 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jul 2018 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
cohort tracking study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post traumatic disorder check list
Time frame: 6 months after trauma
PTSD diagnose
1 secondary outcome
Hamilton depression scale
Time frame: 6 months after trauma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic, run by University Hospital, Tours.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post traumatic disorder check list (time frame: 6 months after trauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.