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

Primary Purpose

Persistent PostConcussion-Like Symptoms, Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
R-TEP EMDR intervention
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Persistent PostConcussion-Like Symptoms focused on measuring Persistent PostConcussion-Like Symptoms, Post-Traumatic Stress Disorder, Emergency Room, EMDR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hopital Pellegrin
  • Hôpital Beaujon
  • Hôpital Louis Mourier
  • CH de Libourne
  • Hôpital Edouard Herriot
  • Hôpital Lariboisière
  • Hôpital Purpan

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Proportion of patients with PTSD at 4-months
Proportion of patients with PTSD at 4-months, measured with the PTSD Checklist-5
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.
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).
Proportion of patients with chronic pain
Proportion of patients with chronic pain at 12-months measured by self-assessed chronic pain.
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
Medication POMI-5F questionnaire
scale medication
Quality of life SF12 questionnaire
Scale quality of life

Full Information

First Posted
April 15, 2021
Last Updated
October 12, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
UH Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04916678
Brief Title
Persistent PostConcussion-Like Symptoms and Post Traumatic Stress Disorder in Patients Presenting at the Emergency Room.
Acronym
SOFTERIV
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
June 22, 2022 (Actual)
Study Completion Date
June 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
UH Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent PostConcussion-Like Symptoms, Post-Traumatic Stress Disorder
Keywords
Persistent PostConcussion-Like Symptoms, Post-Traumatic Stress Disorder, Emergency Room, EMDR

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2897 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
The control period is a 5-day period during which no psychologist is available. ER cares will be provided as usual.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
R-TEP EMDR intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients with PostConcussion-Like Syndrome (PCLS) at 4 months.
Description
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).
Time Frame
4 months after inclusion day
Secondary Outcome Measure Information:
Title
Proportion of patients with PTSD at 4-months
Description
Proportion of patients with PTSD at 4-months, measured with the PTSD Checklist-5
Time Frame
4 months after inclusion day
Title
Establishment of a PCLS Predictive factors list
Description
List of PCLS predictive factors at 4 months in an attempt to improve the current PCLS risk scoring system.
Time Frame
4 months after inclusion day
Title
Assessment of health care consumption
Description
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).
Time Frame
12 months after inclusion day
Title
Proportion of patients with chronic pain
Description
Proportion of patients with chronic pain at 12-months measured by self-assessed chronic pain.
Time Frame
12 months after inclusion day
Title
Establishment of chronic pain predictive factors
Description
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
Time Frame
12 months after inclusion day
Title
Medication POMI-5F questionnaire
Description
scale medication
Time Frame
12 months
Title
Quality of life SF12 questionnaire
Description
Scale quality of life
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel LAGARDE, Pr
Organizational Affiliation
Bordeaux Population Health Research Center (Inserm U1219)
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92000
Country
France
Facility Name
CH de Libourne
City
Libourne
ZIP/Postal Code
33505
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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