Post-Traumatic Stress Disorder Clinical Trial
— SOFTERIVOfficial title:
Persistent PostConcussion-Like Symptoms and Post Traumatic Stress Disorder for Patients Presenting at the Emergency Room: A Multi-center Cluster Randomized Cross-over Implementation Study.
Verified date | April 2024 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Promising results of an early EMDR (Eye Movement Desensitization and Reprocessing) intervention on PCLS (PostConcussion-Like Syndrome) at three months have been shown, suggesting that the availability of psychological care in emergency departments will be useful. The real impact of such a care service remains to be measured. Several factors may modulate the impact of such a measure, leaving the extent of its public health benefit uncertain. In the SOFTER III trial, the results suggest that high levels of self-rated stress at admission probably play a key role in the development of CPSP and psychological intervention. The most appropriate study design for such an objective is to follow a cohort of patients in the Emergency Department and to assess the main risk factors for CPSD 4 months later. To this end, all consecutive patients should be asked to participate in a study and complete a risk factor questionnaire, regardless of their level of risk for CPSD. SOFTER IV offers the opportunity to evaluate the impact of a psychological intervention to reduce the incidence of chronic pain. By acting on the emotions experienced in the Emergency Department, a reduction in acute pain and perhaps in the longer term in chronic pain can be expected. Its psychological aspects, and more specifically the emotional dimension, are known to be related to acute pain. As for the relationship with chronic pain, it exists, but its meaning is not clear because the emotional state is assessed when the pain has already become chronic. It is proposed to integrate the assessment of emotions at inclusion in the project, and to follow up patients 12 months after inclusion to assess the incidence of chronic pain and identify the factors that modulate it. Early intervention in the emergency department, including an early short one-hour EMDR intervention R-TEP (Recent Traumatic Episode Protocol), could thus reduce the incidence of chronic pain.
Status | Completed |
Enrollment | 2897 |
Est. completion date | June 22, 2023 |
Est. primary completion date | June 22, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 and more - Conscious, able to provide informed consent, able to understand study procedures and to comply with them for the entire length of the study. Speaking French. Exclusion Criteria: - Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. - Inability or unwillingness of individual or legal guardian/representative to give written informed consent. - Inability or unwillingness to be contacted for 4-month follow-up interview. - Pregnancy or breastfeeding. - Curatorship or guardianship. - Prisoners. |
Country | Name | City | State |
---|---|---|---|
France | Hopital Pellegrin | Bordeaux | |
France | Hôpital Beaujon | Clichy | |
France | Hôpital Louis Mourier | Colombes | |
France | CH de Libourne | Libourne | |
France | Hôpital Edouard Herriot | Lyon | |
France | Hôpital Lariboisière | Paris | |
France | Hôpital Purpan | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | University of Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with PostConcussion-Like Syndrome (PCLS) at 4 months. | Proportion of patients with PCLS at 4 months, measured with the Rivermead Postconcussion Symptoms Questionnaire. Each item (16) is rated on a 5-point ordinal scale : 0 = Not experienced at all to 4 = A severe problem. The total sore is a sum of all items and ranges from 0 to 64 (best to worst). |
4 months after inclusion day | |
Secondary | Proportion of patients with PTSD at 4-months | Proportion of patients with PTSD at 4-months, measured with the PTSD Checklist-5 | 4 months after inclusion day | |
Secondary | Establishment of a PCLS Predictive factors list | List of PCLS predictive factors at 4 months in an attempt to improve the current PCLS risk scoring system. | 4 months after inclusion day | |
Secondary | Assessment of health care consumption | All health care consumption such as medicinal drugs, medical consultations or hospitalizations in the 12 months following inclusion will be collected thanks to the french national insurance system database (SNIIR-AM). | 12 months after inclusion day | |
Secondary | Proportion of patients with chronic pain | Proportion of patients with chronic pain at 12-months measured by self-assessed chronic pain. | 12 months after inclusion day | |
Secondary | Establishment of chronic pain predictive factors | List of chronic pain predictive factors at 12 months, in an attempt to help to diagnose high-risk patients at an early stage, and provide them with appropriate care | 12 months after inclusion day | |
Secondary | Medication Prescription Opioid Misuse Index scale (POMI-5F) questionnaire | The POMI-5F threshold score for indicating misuse is 2/5 (sensitivity = 0.95 and specificity = 0.54). Each YES answer scores 1 point. POMI-5F does not count answers to questions 4, 7 and 8. A score = 2/5 is a probable sign of misuse. | 12 months after inclusion day | |
Secondary | Quality of life Medical Outcomes Study Short-Form General Health Survey (SF12) questionnaire | The SF-12 test is a shortened version of the Medical Outcomes Study Short-Form General Health Survey (SF-36) containing only 12 of the 36 questions. The SF-12 questionnaire is a general questionnaire for assessing health status: it combines synthetic information that combines a score on the physical dimension and a score on the mental dimension. It contains 12 items, divided into the same 8 dimensions as the SF-36. The score ranges from 0 to 100, with a higher score indicating better physical and mental functioning. |
12 months after inclusion day |
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