An interventional study of R-TEP EMDR in Post-Concussion Symptoms and Post-Traumatic Stress Disorder, sponsored by University Hospital, Bordeaux. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Prevention
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.
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 department (ED). 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 Post-concussion-like symptoms (PCLS). Moreover, PCLS appear to be very similar and sometime overlap 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 PCLS 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 : one of them is Recent Traumatic Episode Protocol EMDR (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 PCLS and PTSD symptoms among a subset of patients screened for their high risk of PCLS.
The study is a two-site open-label two-group randomized controlled trial designed to assess the efficacy of an early R-TEP EMDR intervention performed in the ED by comparing PCLS and PTSD symptoms at 3 and 12 months between the two randomization groups: (i) R-TEP EMDR; (ii) care as usual.
140 studies on the registry are indexed under Post-Concussion Syndrome; 33 are open to participants now.
This study's enrollment of 314 is above the median of 52 across 113 interventional studies indexed under Post-Concussion Syndrome.
Browse Post-Concussion Syndrome studies →University Hospital, Bordeaux is the lead sponsor of 807 studies on the registry; 198 are open to participants now.
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Exclusion Criteria:
Patients in this group continue their usual care without intervention.
Patients in R-TEP EMDR group will receive the intervention.
Behavioral: R-TEP EMDR
Recent Traumatic Episode Protocol Eye-Movement Desensitization and Reprocessing is a early and short adaption protocol of EMDR developed by Shapiro E. EMDR is a psychotherapeutic approach that can rapidly process disturbing experiences adaptively together with the aid of eye movements or other forms of bi-lateral stimulation.
Compare the impact on 3-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP
3-months PCLS as measured with the Rivermead Postconcussion Symptoms Questionnaire
Time frame: 3 months after inclusion visit
Recovery expectation at discharge following participant' recruitment
Self-reported to ER medical staff thanks to a Rivermead questionnaire
Time frame: 3 months after inclusion visit
Acute pain
Self-reported acute pain to ER medical staff using the total score of a 10 points Likert scale
Time frame: 3 months after inclusion visit
Chronic pain
chronic pain will be self-reported thanks to a Rivermead questionnaire
Time frame: 3 months after inclusion visit
Psychotropic medicines use
Psychotropic medicines use will be measured by drug delivery data as extracted from the Caisse national d'assurance maladie des travailleurs salariés (CNAM-TS) database, the French social insurance system.
Time frame: 3 months after inclusion visit
Compare the impact on 12-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP.
12-months PCLS as measured with the the Rivermead Postconcussion Symptoms Questionnaire
Time frame: 12 months after inclusion visit
Compare the impact on 3-months Post-Traumatic Stress Disorder (PTSD) of early EMDR R-TEP.
3-months PTSD as measured with PTSD Checklist-5
Time frame: 3 months after inclusion visit
Plan to share: Yes
Ran from Jan 2018 to primary completion in Oct 2018, 9 months.
Of 54 non-industry interventional studies with no phase under Post-Concussion Syndrome, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 58. This study's 9 months is below that.
Counting every sponsor, half of 56 studies reached it within 40 months; a quarter within 23 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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