- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03264469
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 (PSYCHIC)
DIAGNOSIS and FORENSIC MANAGEMENT OF PSYCHOLOGICAL TRAUMA IN PATIENTS INVOLVED IN THE TERRORIST ATTACK IN NICE ON THE 14TH JULY 2016
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dijon, France, 21079
- CHU Dijon Bourgogne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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PID scale
Time Frame: At baseline
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At baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
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
- LOISEAU 2016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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