Feasibility and Interest of Early Eye-Movement Desensitization and Reprocessing Provided in the Emergency Department for Patients With High Risk of Post Traumatic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- EMDR protocol completion
研究概览
简要总结
Millions people, all over the world, are admitted in the Emergency Department after a trauma or simply to receive medical cares. In France, it represents 10 million patients. Probably because of stress associated with the event, 20% will suffer a combination of non-specifics symptoms which persist for many months and with daily life quality impairment. The investigators hypothesize that an early intervention, such as Eye-Movement, Desensitization and Reprocessing (EMDR) could be performed in the ED and could prevent the occurrence of these symptoms
详细描述
Emergency department are a privileged service for patients suffering from trauma and stressful medical conditions. In France every year 10 million people come or are taken to the emergency room (ER). Many studies have shown that 10-20% of these trauma patients develop a non-specific set of symptoms that can persist for several months after ED assessment. These includes, for example, headache, memory and/or concentration impairment, stress intolerance, irritability... These symptoms lead to an alteration in the quality of social, family and professional life, and therefore affect one to two millions people in France alone.
The association between these symptoms and mild traumatic brain injury (MTBI) has already been demonstrated. It was defined as post-concussion syndrome (PCS) according to the DSM-IV-TR. However, several recent studies have shown that these symptoms are not specific to MTBI but may appear for any type of trauma and event for stressful medical conditions. PCS seems to appear for events occurring in a stressful environment or in people with psychological weaknesses. These symptoms will therefore be referred here to PCS-like syndrome (PCSLS). Moreover, PCS-LS symptoms appear to be very similar to those of the numbing and hyperarousal dimension of the Post Traumatic Stress Disorder (PTSD).
A recent study, carried out by our team in the ED of Bordeaux University Hospital, showed that PCS-LS was associated with a high level of stress at ED discharge, whatever that stress level at entry.
The Eye-Movement Desensitization and Reprocessing (EMDR) is a recognized psychotherapeutic approach in the treatment of PTSD and several single-session versions of the protocol have been proposed (R-TEP EMDR).The investigators hypothesize that the introduction of an early R-TEP EMDR intervention in emergencies can reduce the level of stress and thus the occurrence of the PCSLS and PTSD symptoms among a subset of patients screened for their high risk of PCS-LS.
The study is a single-site open-label three-group randomized controlled trial designed to assess the feasibility of an early R-TEP EMDR intervention performed in the ED and to compare PCS-LS and PTSD symptoms at 3 months between the three randomization groups: (i) TEP-EMDR; (ii) 15' reassurance session; (iii) care as usual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Investigator / Outcomes Assessor
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted in department for a medical or traumatic event, and at risk of developing a PTS.
- •Score resulting from the screening tool> 3 :
- •Female gender: +1 Taking at least one anxiolytic treatment: + 1 Perceived health status prior to admission: Excellent, very good: 0 ; Good: +1 Poor: +2 ; Bad: +3
- •Affiliated to Social Security
排除标准
- •Refusal to participate in the study
- •Admission and / or exit questionnaire not completed
- •Inability to answer questionnaire: any cognitive impairement, language barrier, consciousness disorder...
- •Impossibility of recontacting the patient at a distance from the trauma (no telephone contact ...)
- •Patient already included in the study.
研究组 & 干预措施
Control
usual care
Reassurance
15 minutes psychologist visit
干预措施: Reassurance (Other)
R-TEP EMDR
Recent Traumatic Episode Protocol Eye-Movement Desensitization and Reprocessing (R-TEP EMDR) At the end of cares, before ED discharge, a trained psychologist will conduct a single R-TEP EMDR session. Each session may last about 60 minutes
干预措施: Eye-Movement Desensitization and Reprocessing (EMDR) (Other)
结局指标
主要结局
EMDR protocol completion
时间窗: 12 hours after ED admission
Eye-Movement Desensitization and Reprocessing, performed in a population with high risk of PTS at the Emergency Department thanks to questionnaires
次要结局
- Recovery rate(3 months)
- Post-concussion Syndrome(3 months after ED admission)
- Post-Traumatic Stress Disorder(3 months after ED admission)
- Chronic Pain at 3 months(3 months after ED admission)