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

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.

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.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder; Persistent PostConcussion-Like Symptoms
• Intervention / Treatment: Other: R-TEP EMDR intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 2897
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Hopital Pellegrin
  • Clichy, France, 92110
    • Hôpital Beaujon
  • Colombes, France, 92000
    • Hôpital Louis Mourier
  • Libourne, France, 33505
    • CH de Libourne
  • Lyon, France, 69003
    • Hôpital Edouard Herriot
  • Paris, France, 75010
    • Hopital Lariboisiere
  • Toulouse, France, 31059
    • Hopital Purpan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control period is a 5-day period during which no psychologist is available. ER cares will be provided as usual.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: University of Bordeaux
• Investigators: Study Chair: Emmanuel LAGARDE, Pr, Bordeaux Population Health Research Center (Inserm U1219)

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): June 22, 2022
• Study Completion (Actual): June 22, 2023

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Emergency Room; Post-Traumatic Stress Disorder; EMDR; Persistent PostConcussion-Like Symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Trauma and Stressor Related Disorders; Emergencies; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: CHUBX 2018/63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No