Persistent PostConcussion-Like SymptomsSOFTERIVNCT04916678
Persistent PostConcussion-Like Symptoms and Post Traumatic Stress Disorder in Patients Presenting at the Emergency Room.
A study testing R-TEP EMDR intervention in people with Persistent PostConcussion-Like Symptoms and Post-Traumatic Stress Disorder, run by University Hospital, Bordeaux at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent PostConcussion-Like Symptoms, Post-Traumatic Stress Disorder
- What is being tested?
- R-TEP EMDR intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,897 participants
- Where
- 7 sitesFrance
- Study dates
- 18 Oct 2021to 22 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Hopital Pellegrin
Bordeaux, 33000
Hôpital Beaujon
Clichy, 92110
Hôpital Louis Mourier
Colombes, 92000
CH de Libourne
Libourne, 33505
Hôpital Edouard Herriot
Lyon, 69003
Hôpital Lariboisière
Paris, 75010
Hôpital Purpan
Toulouse, 31059
About this study
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.
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.
Read more
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.
Read the 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).
- Being tested
- R-TEP EMDR intervention
- Keywords
- Persistent PostConcussion-Like Symptoms, Post-Traumatic Stress Disorder, Emergency Room, EMDR
- Medical subject headings
- Stress Disorders, Post-Traumatic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-TEP EMDR interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: R-TEP EMDR intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months after inclusion day
Secondary outcomes (7)
Proportion of patients with PTSD at 4-months
Proportion of patients with PTSD at 4-months, measured with the PTSD Checklist-5
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 12 months after inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start18 Oct 2021
- Primary completion22 Jun 2022
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent PostConcussion-Like SymptomsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 2,897 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bordeaux
- Responsible party
- Sponsor
- Investigators
- Emmanuel LAGARDE, Pr, Study chair, Bordeaux Population Health Research Center (Inserm U1219)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916678
- Sponsor's protocol ID
- CHUBX 2018/63
- Acronym
- SOFTERIV
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2021
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39107668
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04916678
- Acronym / sponsor ID
- SOFTERIV / CHUBX 2018/63
- Keywords
- Persistent PostConcussion-Like Symptoms, Post-Traumatic Stress Disorder, Emergency Room, EMDR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,897 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- University of Bordeaux
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: R-TEP EMDR interventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-TEP EMDR interventionDuring 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. | Other | Intervention |
Primary outcome
Proportion of patients with PostConcussion-Like Syndrome (PCLS) at 4 months.
Time frame: 4 months after inclusion day
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).
7 secondary outcomes
Proportion of patients with PTSD at 4-months
Time frame: 4 months after inclusion day
Establishment of a PCLS Predictive factors list
Time frame: 4 months after inclusion day
Assessment of health care consumption
Time frame: 12 months after inclusion day
Proportion of patients with chronic pain
Time frame: 12 months after inclusion day
Establishment of chronic pain predictive factors
Time frame: 12 months after inclusion day
Medication Prescription Opioid Misuse Index scale (POMI-5F) questionnaire
Time frame: 12 months after inclusion day
Quality of life Medical Outcomes Study Short-Form General Health Survey (SF12) questionnaire
Time frame: 12 months after inclusion day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Derived from this study: PubMed 39107668Tandzi 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel LAGARDE, Pr study chair
Bordeaux Population Health Research Center (Inserm U1219)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing R-TEP EMDR intervention in people with Persistent PostConcussion-Like Symptoms and Post-Traumatic Stress Disorder, run by University Hospital, Bordeaux at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with PostConcussion-Like Syndrome (PCLS) at 4 months. (time frame: 4 months after inclusion day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04916678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.