Predictive Factors of PTSD in Adults Admitted to an Emergency Service

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder; Psychiatric Issue
• Interventions: Other: Filling questionnaires

• Registration Number: NCT03615014
• Lead Sponsor: Hospices Civils de Lyon

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-03
• Study Start: 2019-02-11
• Status Verified: 2019-10
• Primary Completion: 2019-10-09
• Study Completion: 2019-10-09
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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

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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...)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients having trauma	Filling questionnaires	Adults patients having trauma in the month before visiting emergency will fill questionnaires

Primary Outcome Measures

Name	Time	Method
Post Traumatic Stress Disorder (PTSD) occurrence	At 3 months following admission to the emergency service	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.

Secondary Outcome Measures

Name	Time	Method
Post Traumatic Stress Disorder incidence	At 3 months following admission to the emergency service	Presence of Post Traumatic Stress Disorder will be determined by the PCL-5 scale at 3 months following admission to the emergency service (primary outcome measure). Incidence is the rate of newly diagnosed patients of PTSD at 3 months.
Prevalence of high risk patients to develop Post Traumatic Stress Disorder	1 day (at admission to the emergency service)	The high risk of developing Post Traumatic Stress Disorder will be determined by the Impact of Event Scale-Revised (IES-R).; The IES-R is a 22-item self-report questionnaire that assesses subjective distress caused by traumatic events. The IES-R contains sub-scales for avoidance, intrusions and hyperarousal.; Patients will be asked to indicate how much they were distressed or bothered during the past seven days by each item.; Items are rated on a 5-point scale ranging from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely). The IES-R yields a total score ranging from 0 to 88.; A total IES-R score of over 34 signifies patient is at high risk to develop PTSD.
Dissociative experiences	At admission to the emergency service	Describe the patient dissociative disorders using the Questionnaire of Peritraumatic Dissociative Experiments score.; The Peritraumatic Dissociative Experiences Questionnaire (PDEQ) determines the presence and the intensity of the peritraumatic response experienced by the individual at the time of the traumatic event, and in the minutes and hours that followed.; The PDEQ in a 10-item test. Each item is scored from 1 (not at all true) to 5 (extremely true). The total score is the sum of all items. A score above 15 is indicative of significant dissociation.
Complications associated to Post Traumatic Stress Disorder	At 3 months following admission to the emergency service	The severity of depressive symptoms at 3 months will be determined by the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR16).; The QIDS-SR 16 is a self-report questionnaire that assesses the severity of depressive symptoms. The 16 items (questions) on the QIDS-SR16 cover the nine diagnostic symptom criteria used in DSM.; Each item is rated 0-3. The QIDS-SR16 is scored by summing responses for each of the 16 items to obtain a total score ranging from 0 to 27.; A total score from 0 to 5 signifies absence of depression; 6 to 10 mild depression; 11 to 15 moderate depressions, 16 to 20 severe depression and from 21 to 27 very severe depression.
Prevalence of moderate risk patients to develop Post Traumatic Stress Disorder	1 day (at admission to the emergency service)	The moderate risk of developing Post Traumatic Stress Disorder will be determined by the Impact of Event Scale-Revised (IES-R).; The IES-R is a 22-item self-report questionnaire that assesses subjective distress caused by traumatic events. The IES-R contains sub-scales for avoidance, intrusions and hyperarousal.; Patients will be asked to indicate how much they were distressed or bothered during the past seven days by each item.; Items are rated on a 5-point scale ranging from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely). The IES-R yields a total score ranging from 0 to 88.; An IES-R score between 12 and 34 included signifies patient is at moderate risk to develop PTSD.
Social consequences	At 3 months following admission to the emergency service	Describe PTSD impact on professional life by calculating the number of sick leave days over the 3 months

Trial Locations

Locations (5)

CH St Joseph St Luc - Urgences Psychiatriques et Médecine d'urgence; 🇫🇷 Lyon, France

Centre Hospitalier Lyon Sud - Urgences psychiatriques; 🇫🇷 Pierre-Bénite, France

CHU St Etienne - Hôpital Nord - Urgences Psychiatriques; 🇫🇷 Saint-Priest-en-Jarez, France

CHU Clermont - Hôpital G Montpied - Urgences Psychiatriques et Médecine d'urgence; 🇫🇷 Clermont-Ferrand, France

Hôpital Edouard Herriot - Urgences Psychiatrique et Médecine d'urgence; 🇫🇷 Lyon, France