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.

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.

Emergency room intervention to prevent post concussion-like symptoms and post-traumatic stress disorder. A pilot randomized controlled study of a brief eye movement desensitization and reprocessing intervention versus reassurance or usual care.

Up to 20% of patients presenting at an emergency room (ER) after a stressful event will for several months suffer from very diverse long-lasting symptoms and a potentially significant decline in quality of life, often described as post concussion-like symptoms (PCLS). The objectives of our randomized open-label single-center study were to assess the feasibility of psychologist-led interventions in the context of the ER and to compare the effect of eye movement desensitization and reprocessing (EMDR) with reassurance and usual care. Conducted in the ER of Bordeaux University Hospital, the study included patients with a high risk of PCLS randomized in three groups: a 15-min reassurance session, a 60-min session of EMDR, and usual care. Main outcomes were the proportion of interventions that could be carried out and the prevalence of PCSL and post-traumatic stress disorder (PTSD) three months after the ER visit. One hundred and thirty patients with a high risk of PCLS were randomized. No logistic problem or patient refusal was observed. In the EMDR, reassurance and control groups, proportions of patients with PCLS at three months were 18%, 37% and 65% and those with PTSD were 3%, 16% and 19% respectively. The risk ratio for PCLS adjusted for the type of event (injury, non-injury) for the comparison between EMDR and control was 0.36 [95% CI 0.20-0.66]. This is the first randomized controlled trial that shows that a short EMDR intervention is feasible and potentially effective in the context of the ER. The study was registered at ClinicalTrials.gov (NCT03194386).