Abstract
BackgroundRecent 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.MethodsThis 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.DiscussionIn 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 registrationClinical Trials. NCT03400813. Registered 17 January 2018 – retrospectively registered.
Highlights
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
In 2012, the year of the last national survey in France, 10.6 million people attended the emergency room (ER), some of whom did so several times since 18 million visits were recorded in the same year
Potential benefit The trial is designed to test the impact of early eye movement desensitization and reprocessing (EMDR) intervention on PCLS and post-traumatic stress disorder (PTSD) in patients presenting to the ER
Summary
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. 2 million people each year in France are confronted by difficulties of varying degrees whose cause is often unidentified and unrelated to the traumatic event This link is all the more difficult to make as these symptoms appear to be non-specific, and include headaches, concentration disorders, memory problems, stress intolerance, personality change, and irritability. These symptoms have been described for more than 50 years in the context of head trauma, and were referred to as post-concussion syndrome (PCS). In a cross-sectional, observational study of 31,958 high school athletes, Iverson et al [9] found that 19% of uninjured boys and 28% of uninjured girls reported having a symptom burden resembling an ICD-10 diagnosis of PCS; thereafter, these symptoms were frequently described as post-concussion-like symptoms (PCLS)
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