Predictive Factors of PTSD in Adults Admitted to an Emergency Service

NCT03615014 | Completed

• 1 other identifier: 69HCL18_0142
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 5

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).

Conditions

Post Traumatic Stress Disorder; Psychiatric Issue

Outcome Measures

Primary Outcomes (1)

• Post Traumatic Stress Disorder (PTSD) occurrence

  Presence or absence PTSD will be evaluated by the PCL-5 scale (PTSD Checklist for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders -5)). The PCL-5 scale will be completed with patients during a phone interview with a psychologist or a psychiatrist. The PCL-5 is a 20-item questionnaire that assesses the 20 DSM-5 symptoms of PTSD. Patients will be asked to rate how bothered they have been by each item in the past 3-month on a 5-point Likert scale ranging from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely). A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20). Items are summed to provide a total score. The range is 0-80. A total score of 33 or higher signifies the likely presence of PTSD.

  At 3 months following admission to the emergency service

Secondary Outcomes (9)

• Prevalence of high risk patients to develop Post Traumatic Stress Disorder

  1 day (at admission to the emergency service)

• Prevalence of moderate risk patients to develop Post Traumatic Stress Disorder

  1 day (at admission to the emergency service)

• Post Traumatic Stress Disorder incidence

  At 3 months following admission to the emergency service

• Dissociative experiences

  At admission to the emergency service

• Social consequences

  At 3 months following admission to the emergency service

Study Arms (1)

Patients having trauma

OTHER

Adults patients having trauma in the month before visiting emergency will fill questionnaires

Other: Filling questionnaires

Interventions

Filling questionnaires OTHER

Questionnaires will be submitted to patients during their visit to emergency service and 3 months later to evaluate the prevalence of Post Traumatic Stress Disorder and to identify predictive biopsychosocial factors

Patients having trauma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (5)

CHU Clermont - Hôpital G Montpied - Urgences Psychiatriques et Médecine d'urgence

Clermont-Ferrand, 63000, France

Location

CH St Joseph St Luc - Urgences Psychiatriques et Médecine d'urgence

Lyon, 69007, France

Location

Hôpital Edouard Herriot - Urgences Psychiatrique et Médecine d'urgence

Lyon, 69432, France

Location

Centre Hospitalier Lyon Sud - Urgences psychiatriques

Pierre-Bénite, 69310, France

Location

CHU St Etienne - Hôpital Nord - Urgences Psychiatriques

Saint-Priest-en-Jarez, 42270, France

Location

Related Publications (1)

• 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.

  PMID: 31146712 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Clémence BIED, Dr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: February 11, 2019
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)