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

NCT ID: NCT04916678

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2897 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2023-06-22

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.

Detailed Description

The study is a multi-site cluster randomized cross-over trial with two comparative groups. In each site, the recruitment period span over a period of 10 days (5 days for control and 5 days for intervention), The control period is a period during which no psychologist is available. ER cares will be provided as usual. The intervention period is a period during which trained psychologists are available in the ER and will provide 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. When no high-risk patient is identified, psychologist 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. Otherwise, ER cares will be provided as usual.

In either intervention or control period, all consecutive patients will be proposed to participate in the study that consists in:

(i) completing an inclusion questionnaire to describe reasons for ER attendance, current stress level and preexisting health and symptoms and, in the intervention group, to assess PCLS risk level; (ii) being contacted 4 months later to assess PTSD (using the PCL-5 checklist) and PCLS (using Rivermead criteria).

The national health insurance ID will be collected in the inclusion questionnaire and conserve until it can be used, namely after a specific authorization from Commission Nationale Informatique et Liberté (CNIL). This will allow to compare health care consumption levels in the two groups, as recorded in the national insurance system database (SNIIR-AM).

Conditions

Persistent PostConcussion-Like Symptoms; Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type: EXPERIMENTAL

R-TEP EMDR intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bordeaux

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel LAGARDE, Pr

Role: STUDY_CHAIR

Bordeaux Population Health Research Center (Inserm U1219)

Locations

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, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 39107668 (View on PubMed)

Other Identifiers

CHUBX 2018/63

Identifier Type: -

Identifier Source: org_study_id