NCT03615014: ISSUE

Predictive Factors of PTSD in Adults Admitted to an Emergency Service

Completed NA Last updated 19 December 2025

What this trial tests

NA trial testing Filling questionnaires in Post Traumatic Stress Disorder in 460 participants. Completed in 9 October 2019.

Timeline

11 February 2019

Primary endpoint
9 October 2019

9 October 2019

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	460
Start date	11 February 2019
Primary completion	9 October 2019
Estimated completion	9 October 2019
Sites	5 locations across France

Drugs / interventions tested

• Filling questionnaires

Conditions studied

• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →
• Psychiatric Issue — all drugs for Psychiatric Issue →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 18 to 70, any sex, with Post Traumatic Stress Disorder or Psychiatric Issue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

After trauma or stress factor like death exposition, serious injuries or sexual violence, some patients may develop stress reaction characterized by the presence of various symptoms among different categories (reviviscence, negative humor, dissociates symptoms, occasion, hypervigilance). In the month following trauma, the investigators speak of acute stress reaction (ASR) when symptoms are present during at least three days. If symptoms are present one month after trauma, then it is a post-traumatic stress disorder (PTSD).

Among patients visiting emergency after latest trauma, quite a few is in acute stress reaction. However, this reaction is often incorrectly identified by healthcare team, due to lack of oriented medical examination, patients visiting about other complaints (pain, insomnia) and not expressing clearly the trauma context. Yet, it is know that acute stress reaction occurrence and existence of dissociate symptoms after trauma confrontation is considerably predictive of the eventual post-traumatic stress disorder occurrence.

The identification of risk population of post-traumatic stress disorder is not the subject of any particular structured procedure in emergency services while early care of these patients may allow limiting post-traumatic stress disorder occurrence and associate consequences. Previous works on the subject having exclusively targeted some trauma subgroups or some predictive factors subtypes, investigators propose here biopsychosocial global approach that can weight the impact of each parameters.

In this study, investigators aim at determining predictive biopsychosocial factors of the post-traumatic stress disorder occurrence at 3 months in patients visiting emergency after latest trauma (less than one month old) and identified as "high-risk" to develop post-traumatic stress disorder (moderate or high).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Identification of biopSychoSocial factors predictive of post-traUmatic stress disorder in patients admitted to the Emergency department after a trauma (ISSUE): protocol for a multicenter prospective study.
   Wafa MH, Viprey M, Magaud L, Haesebaert J, et al · · 2019 · cited 7× · PMID 31146712 · DOI 10.1186/s12888-019-2154-z