Predictive Factors of PTSD in Adults Admitted to an Emergency Service (ISSUE)
Primary Purpose
Post Traumatic Stress Disorder, Psychiatric Issue
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Filling questionnaires
Sponsored by
About this trial
This is an interventional other trial for Post Traumatic Stress Disorder
Eligibility Criteria
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…)
Sites / Locations
- CHU Clermont - Hôpital G Montpied - Urgences Psychiatriques et Médecine d'urgence
- CH St Joseph St Luc - Urgences Psychiatriques et Médecine d'urgence
- Hôpital Edouard Herriot - Urgences Psychiatrique et Médecine d'urgence
- Centre Hospitalier Lyon Sud - Urgences psychiatriques
- CHU St Etienne - Hôpital Nord - Urgences Psychiatriques
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients having trauma
Arm Description
Adults patients having trauma in the month before visiting emergency will fill questionnaires
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
Social consequences
Describe PTSD impact on professional life by calculating the number of sick leave days over the 3 months
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.
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.
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.
Full Information
NCT ID
NCT03615014
First Posted
July 30, 2018
Last Updated
October 21, 2019
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03615014
Brief Title
Predictive Factors of PTSD in Adults Admitted to an Emergency Service
Acronym
ISSUE
Official Title
Identification of Biopsychosocial Factors Predictive of the Post-traumatic Stress Disorder Occurrence in Patients Admitted to the Emergencies After Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
October 9, 2019 (Actual)
Study Completion Date
October 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Psychiatric Issue
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
460 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients having trauma
Arm Type
Other
Arm Description
Adults patients having trauma in the month before visiting emergency will fill questionnaires
Intervention Type
Other
Intervention Name(s)
Filling questionnaires
Intervention Description
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
Primary Outcome Measure Information:
Title
Post Traumatic Stress Disorder (PTSD) occurrence
Description
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.
Time Frame
At 3 months following admission to the emergency service
Secondary Outcome Measure Information:
Title
Prevalence of high risk patients to develop Post Traumatic Stress Disorder
Description
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.
Time Frame
1 day (at admission to the emergency service)
Title
Prevalence of moderate risk patients to develop Post Traumatic Stress Disorder
Description
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.
Time Frame
1 day (at admission to the emergency service)
Title
Post Traumatic Stress Disorder incidence
Description
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.
Time Frame
At 3 months following admission to the emergency service
Title
Dissociative experiences
Description
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.
Time Frame
At admission to the emergency service
Title
Social consequences
Description
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).
Time Frame
At 3 months following admission to the emergency service
Title
Social consequences
Description
Describe PTSD impact on professional life by calculating the number of sick leave days over the 3 months
Time Frame
At 3 months following admission to the emergency service
Title
Complications associated to Post Traumatic Stress Disorder
Description
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.
Time Frame
At 3 months following admission to the emergency service
Title
Complications associated to Post Traumatic Stress Disorder
Description
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.
Time Frame
At 3 months following admission to the emergency service
Title
Complications associated to Post Traumatic Stress Disorder
Description
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.
Time Frame
At 3 months following admission to the emergency service
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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…)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clémence BIED, Dr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont - Hôpital G Montpied - Urgences Psychiatriques et Médecine d'urgence
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CH St Joseph St Luc - Urgences Psychiatriques et Médecine d'urgence
City
Lyon
ZIP/Postal Code
69007
Country
France
Facility Name
Hôpital Edouard Herriot - Urgences Psychiatrique et Médecine d'urgence
City
Lyon
ZIP/Postal Code
69432
Country
France
Facility Name
Centre Hospitalier Lyon Sud - Urgences psychiatriques
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
CHU St Etienne - Hôpital Nord - Urgences Psychiatriques
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31146712
Citation
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.
Results Reference
derived
Learn more about this trial
Predictive Factors of PTSD in Adults Admitted to an Emergency Service
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