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
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
More Related Trials
-
GAIN Symptoms: Post-traumatic Headache
NCT05857761 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury
NCT01596569 ·Status: COMPLETED ·Phase: NA
-
Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation
NCT02584894 ·Status: COMPLETED ·Phase: NA
-
Accelerated Transcranial Magnetic Stimulation Intervention for Post-Concussion Syndrome
NCT07211919 ·Status: COMPLETED
-
Effects of tDCS for Enhancing Cognitive Function in Individuals With Persistent Post-Concussion Syndrome
NCT06376500 ·Status: RECRUITING ·Phase: NA
-
rTMS for PTSD Comorbid With Major Depressive Disorder
NCT02273063 ·Status: COMPLETED ·Phase: NA
-
rTMS and EEG in DOC Patients
NCT04401319 ·Status: UNKNOWN ·Phase: NA
-
The Efficacy of EMDR in Patients With PTSD in Multiple Sclerosis
NCT01743664 ·Status: UNKNOWN ·Phase: PHASE3
-
EMDR vs Supportive Therapy in Relapse Prevention in Traumatized Bipolar Patients
NCT02634372 ·Status: COMPLETED ·Phase: NA
-
Pilot TMS in Mild TBI
NCT06999304 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) in Bulimia
NCT01530906 ·Status: UNKNOWN ·Phase: NA
-
TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory
NCT04294888 ·Status: TERMINATED ·Phase: NA
-
Remotely Supervised tDCS for Persistent Post-traumatic Headache
NCT04012853 ·Status: COMPLETED ·Phase: NA
-
Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches
NCT05176392 ·Status: RECRUITING ·Phase: NA
-
Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy
NCT02715986 ·Status: COMPLETED ·Phase: NA
-
Effect of tDCS Timing on Safety Memory in PTSD
NCT04152772 ·Status: COMPLETED ·Phase: NA
-
Treatment and Recovery Monitoring of Post TBI Symptoms
NCT02426749 ·Status: COMPLETED ·Phase: NA
-
Reduction of Trauma-induced Intrusions and Amygdala Hyperreactivity Via Non-invasive Brain Stimulation
NCT04325087 ·Status: UNKNOWN ·Phase: NA
-
rTMS Treatment of Persistent Headache and Post Concussion Symptoms Attributed to Mild Traumatic Injury to the Head
NCT03691272 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Eye Movement Desensitization and Reprocessing (EMDR) to Treat Chronic Pruritus
NCT06771375 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients
NCT02213016 ·Status: UNKNOWN ·Phase: PHASE4
-
Enhancing Working Memory in Patients With Early Alzheimer's Disease Through the Use of rTMS
NCT02537496 ·Status: COMPLETED ·Phase: NA
-
Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness
NCT01673126 ·Status: COMPLETED ·Phase: PHASE2
-
Using Repetitive Transcranial Magnetic Stimulation (rTMS) in the Rehabilitation of Chronic Spatial Neglect After Stroke
NCT01000103 ·Status: COMPLETED ·Phase: PHASE3
-
Investigating the Neural Correlates in Memory Retrieval After HD-tDCS
NCT03319134 ·Status: COMPLETED ·Phase: NA