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Trials. 2018 Oct 12;19(1):555. doi: 10.1186/s13063-018-2902-2.

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.

Author information

1
University Hospital of Bordeaux, Pole of Emergency Medicine, Bordeaux, France. cedric.gil-jardine@chu-bordeaux.fr.
2
INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France. cedric.gil-jardine@chu-bordeaux.fr.
3
Emergency Department, University Hospital of Bordeaux, Pellegrin Hospital, Place Amélie Raba-Léon, 33000, Bordeaux, France. cedric.gil-jardine@chu-bordeaux.fr.
4
Bordeaux University Hospital, Centre Hospitalier Universitaire de Bordeaux, 12 rue Dubernat, 33400, Talence, France. cedric.gil-jardine@chu-bordeaux.fr.
5
CASPERTT, Hospital Center of Cadillac, Lormont, France.
6
Department of Emergency Medicine, University Hospital Edouard Herriot, Hospices civils de Lyon, Lyon, France.
7
University Hospital, Claude Bernard University, Lyon, France.
8
INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France.
9
University Hospital of Bordeaux, Pole of Medicine, Bordeaux, France.
10
University Hospital of Bordeaux, Pole of Emergency Medicine, Bordeaux, France.
11
University Hospital of Bordeaux, Pole of Public Health, Bordeaux, France.
12
Department of Psychiatry, University Hospital Edouard Herriot, Hospices civils de Lyon, Lyon, France.
13
EA 7425 Hesper University Hospital, Claude Bernard University, Lyon, France.

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.

KEYWORDS:

Clinical trial; Emergency department; Eye movement desensitization and reprocessing; Post-concussion-like symptoms; Post-traumatic stress disorder; Stress

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