- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05620381
Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018 (ELSSAS)
October 30, 2023 updated by: University Hospital, Strasbourg, France
Evaluation of the prevalence of post-traumatic stress disorder (PTSD), associated risk factors, health care consumption, and sleep disorders in a civilian population exposed to the December 11, 2018, attacks in Strasbourg.
Terrorist attacks have unfortunately become all too frequent on our territory in recent years.
A better knowledge of the psychological and psychiatric repercussions on exposed populations is essential in order to better prevent and treat disorders that can have a major functional impact on the lives of exposed individuals and to adapt care during future similar events
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amaury MENGIN, MD
- Phone Number: 33 3 88 11 57 70
- Email: amaury.mengin@chru-strasbourg.fr
Study Locations
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Strasbourg, France, 67091
- Recruiting
- Service de Psychiatrie d'Urgences, de Liaison et de Psychotraumatologie - CHU de Strasbourg - France
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Contact:
- Amaury MENGIN, MD
- Phone Number: 33 3 88 11 57 70
- Email: amaury.mengin@chru-strasbourg.fr
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Principal Investigator:
- Amaury MENGIN, MD
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Sub-Investigator:
- Pierre VIDAILHET, MD, PhD
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Sub-Investigator:
- Fabrice BERNA, MD, PhD
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Sub-Investigator:
- Claire BEAUFILS, Psychologist
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Sub-Investigator:
- Coline BUCHHEIT, MD
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Sub-Investigator:
- Cédric PALACIO, Psychologist
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Sub-Investigator:
- Frédérique RIEDLIN, Psychologist
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Sub-Investigator:
- Julie ROLLING, MD
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Sub-Investigator:
- Carmen SCHRODER, MD, PhD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Major subject (≥ 18 years old) having been exposed to the attacks of December 11, 2018 in Strasbourg directly or indirectly (presence at the scene or close relative present at the scene)
Description
Inclusion criteria:
- Major subject (≥ 18 years old),
- Having been exposed to the attacks of December 11, 2018 in Strasbourg directly or indirectly (presence at the scene or close relative present at the scene)
- Subject who has not expressed his opposition, after information, to the reuse of his data for the purpose of this research
Exclusion Criteria:
- Subject who has expressed opposition to participating in the study
- Subject under guardianship, curatorship or legal protection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retrospective evaluation of the prevalence of post-traumatic stress disorder (PTSD) in a population exposed to the attacks of December 11, 2018 in Strasbourg
Time Frame: Files analysed retrospectively from February 11, 2018 to November 30, 2019 will be examined
|
Files analysed retrospectively from February 11, 2018 to November 30, 2019 will be examined
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2020
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
November 9, 2022
First Submitted That Met QC Criteria
November 9, 2022
First Posted (Actual)
November 17, 2022
Study Record Updates
Last Update Posted (Actual)
November 2, 2023
Last Update Submitted That Met QC Criteria
October 30, 2023
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7713 (CTEP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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