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PSYCHIC: 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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Completed
CT.gov ID
NCT03264469
Collaborator
(none)
50
Enrollment
1
Location
8
Actual Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    DIAGNOSIS and FORENSIC MANAGEMENT OF PSYCHOLOGICAL TRAUMA IN PATIENTS INVOLVED IN THE TERRORIST ATTACK IN NICE ON THE 14TH JULY 2016
    Actual Study Start Date :
    Sep 1, 2016
    Actual Primary Completion Date :
    May 1, 2017
    Actual Study Completion Date :
    May 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. PID scale [At baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who have registered a complaint leading to the involvement of the Forensic Medicine Department of DIJON CHU to evaluate requests for temporary sick leave for psychological reasons following the event in NICE on the 14 July 2016.
    Exclusion Criteria:

    • Refusal of the patient to attend the consultation proposed by the Forensic Medicine Department of DIJON CHU,

    • Refusal of the patient to take part in a clinical study.

    • Verbal information about the clinical study when the appointment was made by the Forensic Medicine nurse,

    • Reiteration of the verbal information during the consultation,

    • A letter and an official information document given to each patient by the DIJON CHU research Unit stating the objectives and methods of the clinical study,

    • Contact details of the Forensic Medicine Department given to patients if they have any questions about the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Dijon Bourgogne Dijon France 21079

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire Dijon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire Dijon
    ClinicalTrials.gov Identifier:
    NCT03264469
    Other Study ID Numbers:
    • LOISEAU 2016
    First Posted:
    Aug 29, 2017
    Last Update Posted:
    Sep 19, 2017
    Last Verified:
    Sep 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Psychological Trauma

    Study Results

    No Results Posted as of Sep 19, 2017