跳至主要内容
临床试验/NCT05358067
NCT05358067招募中不适用

Predictability of the Clinical Global Impression Scale (CGI) in Post Immediate in Psychotraumatic Impact

Centre Hospitalier Arras8 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2022年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
241
试验地点
8
主要终点
Psychometric properties of the CGI as a predictor of occurrence of post-traumatic stress disorder

研究概览

简要总结

The objective of this study is to evaluate correlation between Clinical Global Impression Scale (CGI) score immediately in patients who have experienced psychotrauma and occurrence of posttraumatic stress disorder at distance from traumatic event. This could allow, in future, implementation of a systematic telephone reminder of psychotraumatized patients when they have a high score on the CGI scale, and thus detect onset of a stress disorder as early as possible, post-traumatic and orientation of these patients on specialized care.

详细描述

A functional unit of Urgent Medical Aid Service (SAMU), Medical-psychological emergency cell (CUMP) is an emergency medical device and provides immediate and post-immediate medico-psychological care for mentally injured people in psychotraumatic situations. CUMP also ensures immediate post follow-up of these patients, as well as departmental organization of psychotrauma consultation.

During the course of the treatment, victims are oriented, with a telephone callback which can be decided, allowing a remote reassessment of any psychotraumatic sequelae of the event. This phone reminder is part of routine practice following a CUMP intervention. The objective is then early detection of sequelae allowing rapid orientation on specific care pathways, in particular on the consultation of psychotrauma.

Post-traumatic stress disorder is a syndromic entity reactive to experience of a traumatogenic event (defined by the brutal, sudden and unexpected confrontation with death, or the loss of physical or psychological integrity), bringing together intrusive symptoms of reliving, behavioral avoidance of stimuli related to the traumatic event, persistent negative alterations in cognitions and mood, and neurovegetative hyperactivity, causing clinically significant distress and impaired the usual functioning of the subject.

Experiencing a psychotraumatic event in one's life is a frequent experience. Epidemiological data show a lifetime prevalence of around 30%. During and/or in the hours following a psychotraumatic event, people experience psychological, physiological and emotional upheavals called peritraumatic distress. Although most people recover on their own, a portion (8.3%) develop post-traumatic stress disorder.

However, one of the main characteristics of post-traumatic stress disorder is the presence of avoidance symptoms. Avoidance can take different forms such as non-confrontation with all the evocative clues of the traumatic event such as places, people and situations related to the traumatic event, but also the avoidance of thoughts, memories, conversations related to the traumatic event. This avoidance of thoughts and conversations can be a barrier to entry into trauma-focused psychotherapy. Indeed, talking about the traumatic event goes against this avoidance. A proactive approach at a distance from the event to re-evaluate the symptomatology of the people involved and thus propose an orientation towards specialized care in the field of psychotrauma in order to counter avoidance would seem entirely relevant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient who has experienced a traumatic event in the last 48 hours;
  • Patient speaking French;

排除标准

  • Patient participating in another clinical trial on the treatment of his psychotraumatic experience.
  • Person deprived of liberty (prisoners, defendants);
  • Persons under legal protection (protected adults: under guardianship, curatorship, etc.);
  • Opposition of the patient to participate in the research.

结局指标

主要结局

Psychometric properties of the CGI as a predictor of occurrence of post-traumatic stress disorder

时间窗: inclusion

Clinical Global Impression Scale (CGI) severity item provided with a seven-point scale of severity of patient's clinical condition (1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.)

次要结局

  • Correlation between CGI score and Peritraumatic Distress Inventory scale score (PDI)(Inclusion)
  • Presence/absence of a consumption of substances (except alcohol) 6 months in connection with traumatic event(6 months)
  • Presence/absence of a major depressive episode at 6 months in connection with traumatic event(6 months)
  • Correlation coefficient between CGI score and PCL 5 score at 1 month.(1 month)
  • Presence/absence of a consumption of alcohol at 6 months in connection with traumatic event(6 months)
  • Presence/absence of a consumption of substances (except alcohol) at 1 month in connection with traumatic event(1 month)
  • Correlation coefficient between CGI score and PCL 5 score at 6 months.(6 months)
  • Presence/absence of a major depressive episode at 1 month in connection with traumatic event(1 month)
  • Presence/absence of a consumption of alcohol at 1 month in connection with traumatic event(1 month)

研究者

发起方
Centre Hospitalier Arras
申办方类型
Other
责任方
Sponsor

研究点 (8)

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