Clinical trial NCT03615014: Predictive Factors of PTSD in Adults Admitted to an Emergency Service
Official title: Identification of Biopsychosocial Factors Predictive of the Post-traumatic Stress Disorder Occurrence in Patients Admitted to the Emergencies After Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Psychiatric Issue
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Man or woman aged between 18 and 70
* Admitted in an emergency service after a trauma less than one month old, defined by death exposition or death threat, serious injury or sexual violence, by one or several of the following;

  * Being directly exposed ;
  * Being direct witness of traumatic event that occurred to other people;
  * Hearing that traumatic event arrived to close family member or close friend. In the case of death penalty or death threat of a family member or a friend, events must have been violent or accidental.
  * Being exposed repeatedly or extremely to aversive characteristics of trauma events (for example: first line actors gathering human remains, cops exposed several times to kid sexual abuse explicit fact).
* Written informed-consent
* Affiliation to the French social security scheme or beneficiary of a similar scheme

Exclusion Criteria:

* Patient not understanding French language
* Patient under guardianship
* Clinical instability making impossible the realization of questionnaires (for example: agitation, vital risk, disorders of consciousness...)

Primary outcomes:
measure: Post Traumatic Stress Disorder (PTSD) occurrence
timeFrame: At 3 months following admission to the emergency service
Secondary outcomes:
measure: Prevalence of high risk patients to develop Post Traumatic Stress Disorder
timeFrame: 1 day (at admission to the emergency service)
measure: Prevalence of moderate risk patients to develop Post Traumatic Stress Disorder
timeFrame: 1 day (at admission to the emergency service)
measure: Post Traumatic Stress Disorder incidence
timeFrame: At 3 months following admission to the emergency service
measure: Dissociative experiences
timeFrame: At admission to the emergency service
measure: Social consequences
timeFrame: At 3 months following admission to the emergency service
measure: Social consequences
timeFrame: At 3 months following admission to the emergency service
measure: Complications associated to Post Traumatic Stress Disorder
timeFrame: At 3 months following admission to the emergency service
measure: Complications associated to Post Traumatic Stress Disorder
timeFrame: At 3 months following admission to the emergency service
measure: Complications associated to Post Traumatic Stress Disorder
timeFrame: At 3 months following admission to the emergency service
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont - Hôpital G Montpied - Urgences Psychiatriques et Médecine d'urgence
city: Lyon
country: France
facility: CH St Joseph St Luc - Urgences Psychiatriques et Médecine d'urgence
city: Lyon
country: France
facility: Hôpital Edouard Herriot - Urgences Psychiatrique et Médecine d'urgence
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud - Urgences psychiatriques
city: Saint-Priest-en-Jarez
country: France
facility: CHU St Etienne - Hôpital Nord - Urgences Psychiatriques
Study officials:
affiliation: Hospices Civils de Lyon
name: Clémence BIED, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wafa MH, Viprey M, Magaud L, Haesebaert J, Leaune E, Poulet E, Bied C, Schott AM. 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. BMC Psychiatry. 2019 May 30;19(1):163. doi: 10.1186/s12888-019-2154-z.