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Predictive Factors of PTSD in Adults Admitted to an Emergency Service

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03615014
Acronym
ISSUE
Enrollment
460
Registered
2018-08-03
Start date
2019-02-11
Completion date
2019-10-09
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder, Psychiatric Issue

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).

Interventions

OTHERFilling 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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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…)

Design outcomes

Primary

MeasureTime frameDescription
Post Traumatic Stress Disorder (PTSD) occurrenceAt 3 months following admission to the emergency servicePresence 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

MeasureTime frameDescription
Prevalence of moderate risk patients to develop Post Traumatic Stress Disorder1 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.
Post Traumatic Stress Disorder incidenceAt 3 months following admission to the emergency servicePresence 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 Disorder1 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.
Social consequencesAt 3 months following admission to the emergency serviceDescribe 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).
Complications associated to Post Traumatic Stress DisorderAt 3 months following admission to the emergency serviceImpact 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.
Dissociative experiencesAt admission to the emergency serviceDescribe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026