Predictive Factors of PTSD in Adults Admitted to an Emergency Service

Post Traumatic Stress Disorder Clinical Trial

— ISSUE  

Official title:

Identification of Biopsychosocial Factors Predictive of the Post-traumatic Stress Disorder Occurrence in Patients Admitted to the Emergencies After Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615014
• Other study ID #: 69HCL18_0142
• Status: Completed
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: October 9, 2019

Study information

• Verified date: October 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: October 9, 2019
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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…)

Related Conditions & MeSH terms

• Emergencies
• Post Traumatic Stress Disorder
• Psychiatric Issue
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Filling questionnaires
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

Locations

Country	Name	City	State
France	CHU Clermont - Hôpital G Montpied - Urgences Psychiatriques et Médecine d'urgence	Clermont-Ferrand
France	CH St Joseph St Luc - Urgences Psychiatriques et Médecine d'urgence	Lyon
France	Hôpital Edouard Herriot - Urgences Psychiatrique 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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of high risk patients to develop Post Traumatic Stress Disorder	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.	1 day (at admission to the emergency service)
Secondary	Prevalence of moderate risk patients to develop Post Traumatic Stress Disorder	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.	1 day (at admission to the emergency service)
Secondary	Post Traumatic Stress Disorder incidence	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.	At 3 months following admission to the emergency service
Secondary	Dissociative experiences	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.	At admission to the emergency service
Secondary	Social consequences	Describe Post Traumatic Stress Disorder impact on social life using the Social Support Questionnaire (SSQ6).; The Social Support Questionnaire 6 (SSQ6) is a 6-item questionnaire designed to measure two dimensions of social support: availability and satisfaction.; Each item is a question that solicits a two-part answer: Part 1 asks participants to list up nine people maximum available to provide support in each of 6 areas, and Part 2 asks participants to indicate how satisfied they are, in general, with these people.; Availability is scored by counting the total number of people for each item (max = 54), and satisfaction is scored by counting the total satisfaction scores for the 6 items (max = 36).	At 3 months following admission to the emergency service
Secondary	Social consequences	Describe PTSD impact on professional life by calculating the number of sick leave days over the 3 months	At 3 months following admission to the emergency service
Secondary	Complications associated to Post Traumatic Stress Disorder	Impact of the excessive drinking and alcohol using the Alcohol Use Disorders Identification Test (AUDIT) at 3 months.; The AUDIT is a 10-item screening tool that assesses alcohol consumption, drinking behaviors, and alcohol-related problems. Each item has a score ranging from 0 to 4.; Total scores of 7 or more in men, 6 or more in women are recommended as indicators of hazardous and harmful alcohol use.	At 3 months following admission to the emergency service
Secondary	Complications associated to Post Traumatic Stress Disorder	Impact of the nicotine dependence at 3 months using the Fagerström test. The Fagerström Test is a standard instrument for assessing the intensity of physical addiction to nicotine.; In scoring the Fagerstrom Test, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10.; A patient who scores between 0 and 2 is classified as no nicotine dependence; a score of 3 or 4 would be considered to have low dependence on nicotine, moderate dependence for a score of 5 or 6, high dependence for a score of 7 or 8, and very high dependence for a score of 8 or over.	At 3 months following admission to the emergency service
Secondary	Complications associated to Post Traumatic Stress Disorder	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.	At 3 months following admission to the emergency service