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Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial

Authors: Cédric Gil-Jardiné, Samantha Al Joboory, Juliane Tortes Saint Jammes, Guillaume Durand, Régis Ribéreau-Gayon, Michel Galinski, Louis-Rachid Salmi, Philippe Revel, Cyril Alexandre Régis, Guillaume Valdenaire, Emmanuel Poulet, Karim Tazarourte, Emmanuel Lagarde

Published in: Trials | Issue 1/2018

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Abstract

Background

Recent data suggest that 10–20% of injury patients will suffer for several months after the event from diverse symptoms, generally referred to as post-concussion-like symptoms (PCLS), which will lead to a decline in quality of life. A preliminary randomized control trial suggested that this condition may be induced by the stress experienced during the event or emergency room (ER) stay and can be prevented in up to 75% of patients with a single, early, short eye movement desensitization and reprocessing (EMDR) psychotherapeutic session delivered in the ER.
The protocol of the SOFTER 3 study was designed to compare the impact on 3-month PCLS of early EMDR intervention and usual care in patients presenting at the ER. Secondary outcomes included 3-month post-traumatic stress disorder, 12-month PCLS, self-reported stress at the ER, self-assessed recovery expectation at discharge and 3 months, and self-reported chronic pain at discharge and 3 months.

Methods

This is a two-group, open-label, multicenter, comparative, randomized controlled trial with 3- and 12-month phone follow-up for reports of persisting symptoms (PCLS and post-traumatic stress disorder). Those eligible for inclusion were adults (≥18 years old) presenting at the ER departments of the University Hospital of Bordeaux and University Hospital of Lyon, assessed as being at high risk of PCLS using a three-item scoring rule. The intervention groups were a (1) EMDR Recent Traumatic Episode Protocol intervention performed by a trained psychologist during ER stay or (2) usual care. The number of patients to be enrolled in each group was 223 to evidence a 15% decrease in PCLS prevalence in the EMDR group.

Discussion

In 2012, the year of the last national survey in France, 10.6 million people attended the ER, some of whom did so several times since 18 million visits were recorded in the same year. The SOFTER 3 study therefore addresses a major public health challenge.

Trial registration

Clinical Trials. NCT03400813. Registered 17 January 2018 – retrospectively registered.
Appendix
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Metadata
Title
Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial
Authors
Cédric Gil-Jardiné
Samantha Al Joboory
Juliane Tortes Saint Jammes
Guillaume Durand
Régis Ribéreau-Gayon
Michel Galinski
Louis-Rachid Salmi
Philippe Revel
Cyril Alexandre Régis
Guillaume Valdenaire
Emmanuel Poulet
Karim Tazarourte
Emmanuel Lagarde
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2902-2

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