<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03264469</url>
  </required_header>
  <id_info>
    <org_study_id>LOISEAU 2016</org_study_id>
    <nct_id>NCT03264469</nct_id>
  </id_info>
  <brief_title>Improvement of the Diagnosis and Medico-legal Management of Psychological Trauma in Patients Involved in the Terrorist Attack in Nice on the 14th July 2016</brief_title>
  <acronym>PSYCHIC</acronym>
  <official_title>DIAGNOSIS and FORENSIC MANAGEMENT OF PSYCHOLOGICAL TRAUMA IN PATIENTS INVOLVED IN THE TERRORIST ATTACK IN NICE ON THE 14TH JULY 2016</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Psychological trauma is a major public health concern that affects numerous patients who have&#xD;
      experienced traumatic events.&#xD;
&#xD;
      The objective of our research was to improve the diagnosis and management of persons&#xD;
      experiencing such events.&#xD;
&#xD;
      We will seek to determine factors brought into play in the construction of psychological&#xD;
      trauma and the best way to identify them so as to implement the optimal management of&#xD;
      patients and ensure recognition of this condition.&#xD;
&#xD;
      In addition, in the context of our activity as expert witnesses, we will study the methods&#xD;
      used to assess and quantify psychological trauma.&#xD;
&#xD;
      In this respect, a medical appointment will be made by a nurse of the Forensic Medicine&#xD;
      Department of Dijon CHU. During this consultation, a self-report questionnaire will be&#xD;
      completed by the patient alone to evaluate the level of acute stress followed by a&#xD;
      psychiatric consultation and completion of the IES-R questionnaire with the doctor to&#xD;
      identify symptoms of psychological trauma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PID scale</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Registration of a Complaint Following the Terrorist Attack of 14 July 2016</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Registration of a complaint following the terrorist attack of 14 July 2016&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients who have registered a complaint leading to the involvement of the Forensic&#xD;
        Medicine Department of DIJON CHU to evaluate requests for temporary sick leave for&#xD;
        psychological reasons following the event in NICE on the 14 July 2016.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient to attend the consultation proposed by the Forensic Medicine&#xD;
             Department of DIJON CHU,&#xD;
&#xD;
          -  Refusal of the patient to take part in a clinical study.&#xD;
&#xD;
          -  Verbal information about the clinical study when the appointment was made by the&#xD;
             Forensic Medicine nurse,&#xD;
&#xD;
          -  Reiteration of the verbal information during the consultation,&#xD;
&#xD;
          -  A letter and an official information document given to each patient by the DIJON CHU&#xD;
             research Unit stating the objectives and methods of the clinical study,&#xD;
&#xD;
          -  Contact details of the Forensic Medicine Department given to patients if they have any&#xD;
             questions about the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 18, 2017</last_update_submitted>
  <last_update_submitted_qc>September 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychological Trauma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03264469
org study id: LOISEAU 2016
nct id: NCT03264469
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Psychological trauma is a major public health concern that affects numerous patients who have
      experienced traumatic events.

      The objective of our research was to improve the diagnosis and management of persons
      experiencing such events.

      We will seek to determine factors brought into play in the construction of psychological
      trauma and the best way to identify them so as to implement the optimal management of
      patients and ensure recognition of this condition.

      In addition, in the context of our activity as expert witnesses, we will study the methods
      used to assess and quantify psychological trauma.

      In this respect, a medical appointment will be made by a nurse of the Forensic Medicine
      Department of Dijon CHU. During this consultation, a self-report questionnaire will be
      completed by the patient alone to evaluate the level of acute stress followed by a
      psychiatric consultation and completion of the IES-R questionnaire with the doctor to
      identify symptoms of psychological trauma.
observational model: Case-Only
time perspective: Prospective
measure: PID scale
time frame: At baseline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Psychological Trauma