Registration of a Complaint Following the Terrorist Attack of 14 July 2016PSYCHICNCT03264469
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
An observational study of Registration of a Complaint Following the Terrorist Attack of 14 July 2016, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Registration of a Complaint Following the Terrorist Attack of 14 July 2016
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to May 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Registration of a complaint following the terrorist attack of 14 July 2016
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
PID scale
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study startSep 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Registration of a Complaint Following the Terrorist Attack of 14 July 2016Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264469
- Sponsor's protocol ID
- LOISEAU 2016
- Acronym
- PSYCHIC
- Status last verified
- Sep 2017
- First submitted
- 25 Aug 2017
- Last updated
- 19 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIAGNOSIS and FORENSIC MANAGEMENT OF PSYCHOLOGICAL TRAUMA IN PATIENTS INVOLVED IN THE TERRORIST ATTACK IN NICE ON THE 14TH JULY 2016
- ClinicalTrials.gov ID
- NCT03264469
- Acronym / sponsor ID
- PSYCHIC / LOISEAU 2016
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 29 Aug 2017 (actual)
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Registration of a complaint following the terrorist attack of 14 July 2016
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
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
PID scale
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Registration of a Complaint Following the Terrorist Attack of 14 July 2016, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 6 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: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PID scale (time frame: At baseline). 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 19 Sep 2017.