Persistent PostConcussion-Like Symptoms and Post Traumatic Stress Disorder in Patients Presenting at the Emergency Room.

NCT04916678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2897

Last updated 2024-04-26

No results posted yet for this study

Summary

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.

Conditions

  • Persistent PostConcussion-Like Symptoms
  • Post-Traumatic Stress Disorder

Interventions

OTHER

R-TEP EMDR intervention

During the intervention period, trained psychologists are available in the ER and will provide preferentially a short early 1-hour R-TEP EMDR intervention for patients selected with high risk of PCLS. Patient's selection will be conducted using a score developed in previous studies. If therapist considers R-TEP EMDR unsuitable, he could provide another type of intervention (such as reassurance) that will be recorded. When no high-risk patient is identified, the therapist could assess other patients and treat them if judged necessary. In this context, they could provide either a R-TEP EMDR or short intervention such as reassurance according to therapist assessment.

Sponsors & Collaborators

  • University of Bordeaux

    collaborator OTHER
  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Emmanuel LAGARDE, Pr · Bordeaux Population Health Research Center (Inserm U1219)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-18
Primary Completion
2022-06-22
Completion
2023-06-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04916678 on ClinicalTrials.gov