Post Traumatic Stress DisorderISSUENCT03615014
Predictive Factors of PTSD in Adults Admitted to an Emergency Service
A study testing Filling questionnaires in people with Post Traumatic Stress Disorder and Psychiatric Issue, run by Hospices Civils de Lyon at 5 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Psychiatric Issue
- What is being tested?
- Filling questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 5 sitesFrance
- Study dates
- 11 Feb 2019to 9 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient not understanding French language
- Patient under guardianship
- Clinical instability making impossible the realization of questionnaires (for example: agitation, vital risk, disorders of consciousness…)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Clermont - Hôpital G Montpied - Urgences Psychiatriques et Médecine d'urgence
Clermont-Ferrand, 63000
CH St Joseph St Luc - Urgences Psychiatriques et Médecine d'urgence
Lyon, 69007
Hôpital Edouard Herriot - Urgences Psychiatrique et Médecine d'urgence
Lyon, 69432
Centre Hospitalier Lyon Sud - Urgences psychiatriques
Pierre-Bénite, 69310
CHU St Etienne - Hôpital Nord - Urgences Psychiatriques
Saint-Priest-en-Jarez, 42270
About this study
Official title: Identification of Biopsychosocial Factors Predictive of the Post-traumatic Stress Disorder Occurrence in Patients Admitted to the Emergencies After Trauma
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.
Read more
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
- Being tested
- Filling questionnaires
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling questionnairesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients having trauma | Other | Adults patients having trauma in the month before visiting emergency will fill questionnaires Receives: Other: Filling questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 months following admission to the emergency service
Secondary outcomes (9)
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.
Measured: 1 day (at admission to the emergency service)
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.
Measured: 1 day (at admission to the emergency service)
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.
Measured: At 3 months following admission to the emergency service
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.
Measured: At admission to the emergency service
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).
Measured: At 3 months following admission to the emergency service
Social consequences
Describe PTSD impact on professional life by calculating the number of sick leave days over the 3 months
Measured: At 3 months following admission to the emergency service
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.
Measured: At 3 months following admission to the emergency service
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.
Measured: At 3 months following admission to the emergency service
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.
Measured: At 3 months following admission to the emergency service
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start11 Feb 2019
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clémence BIED, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615014
- Sponsor's protocol ID
- 69HCL18_0142
- Acronym
- ISSUE
- Status last verified
- Dec 2025
- First submitted
- 30 Jul 2018
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31146712
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biopsychosocial Factors Predictive of the Post-traumatic Stress Disorder Occurrence in Patients Admitted to the Emergencies After Trauma
- ClinicalTrials.gov ID
- NCT03615014
- Acronym / sponsor ID
- ISSUE / 69HCL18_0142
- Conditions
- Post Traumatic Stress Disorder, Psychiatric Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients having trauma | Other | Other: Filling questionnairesAdults patients having trauma in the month before visiting emergency will fill questionnaires |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
- Written informed-consent
- Affiliation to the French social security scheme or beneficiary of a similar scheme
Key exclusion criteria (3 listed)
- Patient not understanding French language
- Patient under guardianship
- Clinical instability making impossible the realization of questionnaires (for example: agitation, vital risk, disorders of consciousness…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filling questionnairesQuestionnaires 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 | Other | Patients having trauma |
Primary outcome
Post Traumatic Stress Disorder (PTSD) occurrence
Time frame: 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.
9 secondary outcomes
Prevalence of high risk patients to develop Post Traumatic Stress Disorder
Time frame: 1 day (at admission to the emergency service)
Prevalence of moderate risk patients to develop Post Traumatic Stress Disorder
Time frame: 1 day (at admission to the emergency service)
Post Traumatic Stress Disorder incidence
Time frame: At 3 months following admission to the emergency service
Dissociative experiences
Time frame: At admission to the emergency service
Social consequences
Time frame: At 3 months following admission to the emergency service
Social consequences
Time frame: At 3 months following admission to the emergency service
Complications associated to Post Traumatic Stress Disorder
Time frame: At 3 months following admission to the emergency service
Complications associated to Post Traumatic Stress Disorder
Time frame: At 3 months following admission to the emergency service
Complications associated to Post Traumatic Stress Disorder
Time frame: At 3 months following admission to the emergency service
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 31146712Wafa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clémence BIED, Dr principal investigator
Hospices Civils de Lyon
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filling questionnaires in people with Post Traumatic Stress Disorder and Psychiatric Issue, run by Hospices Civils de Lyon at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Traumatic Stress Disorder (PTSD) occurrence (time frame: At 3 months following admission to the emergency service). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.