Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT05488418
Eligibility Criteria:
Inclusion Criteria:
* Exposure to a traumatic event within 30 days, as defined by ESA criteria A of the DSM-5
* Signed free and informed consent
* Covered by a health insurance company
* 18 to 65 years at inclusion
* Available for a 12-month period follow-up
* Have the ability to speak, read, and understand French
* Have the ability to complete clinical evaluations and self-report measures at baseline and throughout the study
Exclusion Criteria:
* Have any condition for which, in the opinion of the investigator or designee, study participation would not be in their best interest (including but not limited to unstable general medical condition, pregnancy) or that could prevent, limit, or confound the protocol-specified assessments
* One or more criteria for ineligibility for registration on the National Registry of Volunteers for Research Involving Humans (VRB)
* History of stable or non-stable psychiatric illness such as bipolar disorder or schizophrenia or any other pathology that may interfere with the evaluations
* Diagnostic of neurological disorder affecting central nervous system function
* Moderate to severe substance use disorders (\>=4/11 as defined in DSM-5) and excluding smoking disorders
* Volunteers under court protection or guardianship
* Unable to give the volunteer informed information, or the volunteer refuses to sign the consent form
* Physiological condition deemed clinically incompatible with the study by the investigator o For subjects undergoing MRI: presence of a contraindication for MRI examination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05488418
Study Brief:
Protocol Section:
NCT05488418