Eye-Movement Desensitization and Reprocessing in the ED and Post-Traumatic Syndrome (EMDR-ED)
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|ClinicalTrials.gov Identifier: NCT03194386|
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorder||Other: Reassurance Other: Eye-Movement Desensitization and Reprocessing (EMDR)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Investigator / Outcomes Assessor|
|Official Title:||Feasibility and Interest of Early Eye-Movement Desensitization and Reprocessing Provided in the Emergency Department for Patients With High Risk of Post Traumatic Syndrome|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||June 2017|
No Intervention: Control
Active Comparator: Reassurance
15 minutes psychologist visit
At the end of cares, before ED discharge, a trained psychologist will conduct a session in order to reassure patients about their future after ED visit.
Experimental: 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
Other: Eye-Movement Desensitization and Reprocessing (EMDR)
At the end of cares, before ED discharge, a trained psychologist will conduct a single EMDR session. Each session may last about 60 minutes
- EMDR protocol completion [ Time Frame: 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
- Recovery rate [ Time Frame: 3 months ]3 months after ED admission
- Post-concussion Syndrome [ Time Frame: 3 months after ED admission ]Post-Concussion Syndrome (PCS) was assessed using the various definitions of PCS (ICD-10, DSM IV and Rivermaid) were selected: headache, feelings of dizziness, nausea or vomiting, noise sensitivity, sleeping disorders, fatigue, irritability, feeling depressed, anxiety, intolerance to stress, feeling frustrated or impatient, forgetfulness or poor memory, poor concentration, taking longer to think, blurred vision, double vision, light sensitivity, restlessness, personality change. In line with PCS definition in the context of mild head injury, we defined patients with PCS as those who reported at least 3 of these symptoms.
- Post-Traumatic Stress Disorder [ Time Frame: 3 months after ED admission ]Post-Traumatic Stress Disorder was defined using the PTSD Check-List Scale. The presence of the 17 symptoms of the DSM-IV-R definition for PTSD were also assessed for the 3-month phone The diagnosis of PTSD requires that one or more symptoms from each of those categories be present for at least a month and that those symptoms interfere seriously with leading a normal life.
- Chronic Pain at 3 months [ Time Frame: 3 months after ED admission ]Self reported by phone
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194386
|Emergency department, Bordeaux University Hospital|
|Bordeaux, France, 33076|
|Study Director:||Emmanuel Lagarde, PhD||University Hospital Bordeaux, France|