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

NCT04916678 | Completed

• 1 other identifier: CHUBX 2018/63
• Study Type: interventional
• Target: 2,897
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Persistent PostConcussion-Like Symptoms; Post-Traumatic Stress Disorder; Emergency Room; EMDR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of patients with PTSD at 4-months

  4 months after inclusion day

• Establishment of a PCLS Predictive factors list

  4 months after inclusion day

• Assessment of health care consumption

  12 months after inclusion day

• Proportion of patients with chronic pain

  12 months after inclusion day

• Establishment of chronic pain predictive factors

  12 months after inclusion day

Study Arms (2)

Control

NO INTERVENTION

The control period is a 5-day period during which no psychologist is available. ER cares will be provided as usual.

Intervention

EXPERIMENTAL

The intervention period is a 5-day period during which trained psychologists are available in the ER and will provide a R-TEP EMDR intervention for patients selected with high risk of PCLS and who may provide psychotherapeutic care or reassurance to other patients should they be identified in need of help.

Other: R-TEP EMDR intervention

Interventions

R-TEP EMDR intervention OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• University of Bordeaux: collaborator

Study Sites (7)

Hopital Pellegrin

Bordeaux, 33000, France

Location

Hôpital Beaujon

Clichy, 92110, France

Location

Hôpital Louis Mourier

Colombes, 92000, France

Location

CH de Libourne

Libourne, 33505, France

Location

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Purpan

Toulouse, 31059, France

Location

Related Publications (1)

• Tandzi Tonleu F, Pilet C, Lagarde E, Gil-Jardine C, Galinski M, Lafont S. Subjective risk factors of severe pain at discharge from the emergency department. Intern Emerg Med. 2025 Apr;20(3):899-907. doi: 10.1007/s11739-024-03730-4. Epub 2024 Aug 6.

  PMID: 39107668 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Emergencies

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel LAGARDE, Pr

  Bordeaux Population Health Research Center (Inserm U1219)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a multi-site cluster randomized cross-over trial with two comparative groups. In each site, the control period and intervention period span over a period of 10 days (5 days for control and 5 days for intervention). The sequence of the control and intervention periods will be set at random.

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: June 7, 2021
• Study Start: October 18, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)