Eye-Movement Desensitization and Post-Traumatic Syndroms (SOFTER3)
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|ClinicalTrials.gov Identifier: NCT03400813|
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post-Concussion Symptoms Post-Traumatic Stress Disorder||Behavioral: R-TEP 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||446 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Investigator / Outcomes Assessor|
|Official Title:||Prevention of PostConcussion-Like Symptoms for Patients Presenting at the Emergency Room: A Randomized Controlled Study of Early Single Eye Movement Desensitization and Reprocessing (EMDR) Intervention Versus Usual Care|
|Actual Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||October 31, 2018|
|Estimated Study Completion Date :||July 15, 2019|
No Intervention: Control
Patients in this group continue their usual care without intervention.
Experimental: R-TEP EMDR
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 [ Time Frame: 3 months after inclusion visit ]3-months PCLS as measured with the Rivermead Postconcussion Symptoms Questionnaire
- Recovery expectation at discharge following participant' recruitment [ Time Frame: 3 months after inclusion visit ]Self-reported to ER medical staff thanks to a Rivermead questionnaire
- Acute pain [ Time Frame: 3 months after inclusion visit ]Self-reported acute pain to ER medical staff using the total score of a 10 points Likert scale
- Chronic pain [ Time Frame: 3 months after inclusion visit ]chronic pain will be self-reported thanks to a Rivermead questionnaire
- Psychotropic medicines use [ Time Frame: 3 months after inclusion visit ]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.
- Compare the impact on 12-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP. [ Time Frame: 12 months after inclusion visit ]12-months PCLS as measured with the the Rivermead Postconcussion Symptoms Questionnaire
- Compare the impact on 3-months Post-Traumatic Stress Disorder (PTSD) of early EMDR R-TEP. [ Time Frame: 3 months after inclusion visit ]3-months PTSD as measured with PTSD Checklist-5
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): NCT03400813
|Emergency department, Bordeaux University Hospital|
|Bordeaux, France, 33076|
|University Hospital, Lyon|
|Lyon, France, 69000|
|Study Director:||Emmanuel Lagarde, PhD||University Hospital Bordeaux, France|