Identification of Biopsychosocial Factors Predictive of the Post-traumatic Stress Disorder Occurrence in Patients Admitted to the Emergencies After Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 10
- 主要终点
- Post Traumatic Stress Disorder (PTSD) occurrence
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient not understanding French language
- •Patient under guardianship
- •Clinical instability making impossible the realization of questionnaires (for example: agitation, vital risk, disorders of consciousness…)
研究组 & 干预措施
Patients having trauma
Adults patients having trauma in the month before visiting emergency will fill questionnaires
干预措施: Filling questionnaires (Other)
结局指标
主要结局
Post Traumatic Stress Disorder (PTSD) occurrence
时间窗: 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.
次要结局
- Post Traumatic Stress Disorder incidence(At 3 months following admission to the emergency service)
- Prevalence of high risk patients to develop Post Traumatic Stress Disorder(1 day (at admission to the emergency service))
- Dissociative experiences(At admission to the emergency service)
- Prevalence of moderate risk patients to develop Post Traumatic Stress Disorder(1 day (at admission to the emergency service))
- Social consequences(At 3 months following admission to the emergency service)
- Complications associated to Post Traumatic Stress Disorder(At 3 months following admission to the emergency service)