Post-Traumatic Stress Disorder Clinical Trial
— SOFTER3Official 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
Verified date | July 2019 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Millions people, all over the world, are admitted in the Emergency Department after a trauma or simply to receive medical cares. In France, it represents 10 million patients. Probably because of stress associated with the event, 20% will suffer a combination of non-specifics symptoms which persist for many months and with daily life quality impairment. The investigators hypothesize that an early intervention, such as Eye-Movement, Desensitization and Reprocessing (EMDR) could be performed in the ED and could prevent the occurrence of these symptoms.
Status | Completed |
Enrollment | 314 |
Est. completion date | July 15, 2019 |
Est. primary completion date | October 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients admitted in department (i) injured whatever the cause of injury. The event causing the injury must have occurred in the past 12 hours; or (ii) experiencing a medical event associated with a medical acute condition and presenting for the first time at the ED for this motive - Score resulting from the screening tool>= 2 : Female gender: +1 Taking at least one anxiolytic treatment: + 1 Perceived health status prior to admission: Excellent, very good: 0 ; Good: +1 Poor: +2 ; Bad: +3 - Affiliated to French insurance system. Exclusion Criteria: - Refusal to participate in the study - Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. - Inability to answer questionnaire: any cognitive impairement, language barrier, consciousness disorder... - Impossibility of recontacting the patient at a distance from the trauma (no telephone contact ...) - Patient already included in the study. |
Country | Name | City | State |
---|---|---|---|
France | Emergency department, Bordeaux University Hospital | Bordeaux | |
France | University Hospital, Lyon | Lyon |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | Centre Hospitalier de Cadillac, France, Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare the impact on 3-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP | 3-months PCLS as measured with the Rivermead Postconcussion Symptoms Questionnaire | 3 months after inclusion visit | |
Secondary | Recovery expectation at discharge following participant' recruitment | Self-reported to ER medical staff thanks to a Rivermead questionnaire | 3 months after inclusion visit | |
Secondary | Acute pain | Self-reported acute pain to ER medical staff using the total score of a 10 points Likert scale | 3 months after inclusion visit | |
Secondary | Chronic pain | chronic pain will be self-reported thanks to a Rivermead questionnaire | 3 months after inclusion visit | |
Secondary | Psychotropic medicines use | Psychotropic medicines use will be measured by drug delivery data as extracted from the Caisse national d'assurance maladie des travailleurs salariƩs (CNAM-TS) database, the French social insurance system. | 3 months after inclusion visit | |
Secondary | Compare the impact on 12-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP. | 12-months PCLS as measured with the the Rivermead Postconcussion Symptoms Questionnaire | 12 months after inclusion visit | |
Secondary | Compare the impact on 3-months Post-Traumatic Stress Disorder (PTSD) of early EMDR R-TEP. | 3-months PTSD as measured with PTSD Checklist-5 | 3 months after inclusion visit |
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