Post-Concussion SymptomsSOFTER3NCT03400813
Eye-Movement Desensitization and Post-Traumatic Syndroms
A study testing R-TEP EMDR in people with Post-Concussion Symptoms and Post-Traumatic Stress Disorder, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
Millions people, all over the world, are admitted in the Emergency Department after a trauma or simply to receive medical cares. In France, it represents 10 million patients. Probably because of stress associated with the event, 20% will suffer a combination of non-specifics symptoms which persist for many months and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Concussion Symptoms, Post-Traumatic Stress Disorder
- What is being tested?
- R-TEP EMDR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jan 2018to 15 Jul 2019
- 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
- Patients admitted in department (i) injured whatever the cause of injury. The event causing the injury must have occurred in the past 12 hours; or (ii) experiencing a medical event associated with a medical acute condition and presenting for the first time at the ED for this motive
- Score resulting from the screening tool>= 2 : Female gender: +1 Taking at least one anxiolytic treatment: + 1 Perceived health status prior to admission: Excellent, very good: 0 ; Good: +1 Poor: +2 ; Bad: +3
- Affiliated to French insurance system.
Who cannot join
- Refusal to participate in the study
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability to answer questionnaire: any cognitive impairement, language barrier, consciousness disorder...
- Impossibility of recontacting the patient at a distance from the trauma (no telephone contact ...)
- Patient already included in the study.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Emergency department, Bordeaux University Hospital
Bordeaux, 33076
University Hospital, Lyon
Lyon, 69000
About this study
Official title: Prevention of PostConcussion-Like Symptoms for Patients Presenting at the Emergency Room: A Randomized Controlled Study of Early Single Eye Movement Desensitization and Reprocessing (EMDR) Intervention Versus Usual Care
Millions people, all over the world, are admitted in the Emergency Department after a trauma or simply to receive medical cares. In France, it represents 10 million patients. Probably because of stress associated with the event, 20% will suffer a combination of non-specifics symptoms which persist for many months and with daily life quality impairment. The investigators hypothesize that an early intervention, such as Eye-Movement, Desensitization and Reprocessing (EMDR) could be performed in the ED and could prevent the occurrence of these symptoms.
Read the detailed description
Emergency department are a privileged service for patients suffering from trauma and stressful medical conditions. In France, every year 10 million people come or are taken to the emergency department (ED). Many studies have shown that 10-20% of these trauma patients develop a non-specific set of symptoms that can persist for several months after ED assessment. These includes, for example, headache, memory and/or concentration impairment, stress intolerance, irritability... These symptoms lead to an alteration in the quality of social, family and professional life, and therefore affect one to two millions people in France alone.
The association between these symptoms and mild traumatic brain injury (MTBI) has already been demonstrated. It was defined as post-concussion syndrome (PCS) according to the DSM-IV-TR. However, several recent studies have shown that these symptoms are not specific to MTBI but may appear for any type of trauma and event for stressful medical conditions. PCS seems to appear for events occurring in a stressful environment or in people with psychological weaknesses. These symptoms will therefore be referred here to Post-concussion-like symptoms (PCLS). Moreover, PCLS appear to be very similar and sometime overlap those of the numbing and hyperarousal dimension of the Post Traumatic Stress Disorder (PTSD).
A recent study, carried out by our team in the ED of Bordeaux University Hospital, showed that PCLS was associated with a high level of stress at ED discharge, whatever that stress level at entry.
The Eye-Movement Desensitization and Reprocessing (EMDR) is a recognized psychotherapeutic approach in the treatment of PTSD and several single-session versions of the protocol have been proposed : one of them is Recent Traumatic Episode Protocol EMDR (R-TEP EMDR).The investigators hypothesize that the introduction of an early R-TEP EMDR intervention in emergencies can reduce the level of stress and thus the occurrence of the PCLS and PTSD symptoms among a subset of patients screened for their high risk of PCLS.
The study is a two-site open-label two-group randomized controlled trial designed to assess the efficacy of an early R-TEP EMDR intervention performed in the ED by comparing PCLS and PTSD symptoms at 3 and 12 months between the two randomization groups: (i) R-TEP EMDR; (ii) care as usual.
- Being tested
- R-TEP EMDR
- Keywords
- Eye-Movement Desensitization, Reprocessing
- Medical subject headings
- Post-Concussion Syndrome, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-TEP EMDRBehavioural
Recent Traumatic Episode Protocol Eye-Movement Desensitization and Reprocessing is a early and short adaption protocol of EMDR developed by Shapiro E. EMDR is a psychotherapeutic approach that can rapidly process disturbing experiences adaptively together with the aid of eye movements or other forms of bi-lateral stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in this group continue their usual care without intervention. |
| R-TEP EMDR | Experimental | Patients in R-TEP EMDR group will receive the intervention. Receives: Behavioral: R-TEP EMDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the impact on 3-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP
3-months PCLS as measured with the Rivermead Postconcussion Symptoms Questionnaire
Measured: 3 months after inclusion visit
Secondary outcomes (6)
Recovery expectation at discharge following participant' recruitment
Self-reported to ER medical staff thanks to a Rivermead questionnaire
Measured: 3 months after inclusion visit
Acute pain
Self-reported acute pain to ER medical staff using the total score of a 10 points Likert scale
Measured: 3 months after inclusion visit
Chronic pain
chronic pain will be self-reported thanks to a Rivermead questionnaire
Measured: 3 months after inclusion visit
Psychotropic medicines use
Psychotropic medicines use will be measured by drug delivery data as extracted from the Caisse national d'assurance maladie des travailleurs salariés (CNAM-TS) database, the French social insurance system.
Measured: 3 months after inclusion visit
Compare the impact on 12-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP.
12-months PCLS as measured with the the Rivermead Postconcussion Symptoms Questionnaire
Measured: 12 months after inclusion visit
Compare the impact on 3-months Post-Traumatic Stress Disorder (PTSD) of early EMDR R-TEP.
3-months PTSD as measured with PTSD Checklist-5
Measured: 3 months after inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start15 Jan 2018
- Primary completion31 Oct 2018
- Study completion15 Jul 2019
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 Post-Concussion SymptomsStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Cadillac, Hospices Civils de Lyon
- Responsible party
- Sponsor
- Investigators
- Emmanuel Lagarde, PhD, Study director, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400813
- Sponsor's protocol ID
- CHUBX 2017/13
- Acronym
- SOFTER3
- Status last verified
- Jul 2019
- First submitted
- 20 Nov 2017
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gil-Jardine C, Al Joboory S, Jammes JTS, Durand G, Ribereau-Gayon R, Galinski M, Salmi LR, Revel P, Regis CA, Valdenaire G, Poulet E, Tazarourte K, Lagarde E. Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial. Trials. 2018 Oct 12;19(1):555. doi: 10.1186/s13063-018-2902-2.
PubMed 30314512
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of PostConcussion-Like Symptoms for Patients Presenting at the Emergency Room: A Randomized Controlled Study of Early Single Eye Movement Desensitization and Reprocessing (EMDR) Intervention Versus Usual Care
- ClinicalTrials.gov ID
- NCT03400813
- Acronym / sponsor ID
- SOFTER3 / CHUBX 2017/13
- Keywords
- Eye-Movement Desensitization, Reprocessing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Cadillac, Hospices Civils de Lyon
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 17 Jan 2018 (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.
Millions people, all over the world, are admitted in the Emergency Department after a trauma or simply to receive medical cares. In France, it represents 10 million patients. Probably because of stress associated with the event, 20% will suffer a combination of non-specifics symptoms which persist for many months and with daily life quality impairment. The investigators hypothesize that an early intervention, such as Eye-Movement, Desensitization and Reprocessing (EMDR) could be performed in the ED and could prevent the occurrence of these symptoms.
Detailed description
Emergency department are a privileged service for patients suffering from trauma and stressful medical conditions. In France, every year 10 million people come or are taken to the emergency department (ED). Many studies have shown that 10-20% of these trauma patients develop a non-specific set of symptoms that can persist for several months after ED assessment. These includes, for example, headache, memory and/or concentration impairment, stress intolerance, irritability... These symptoms lead to an alteration in the quality of social, family and professional life, and therefore affect one to two millions people in France alone.
The association between these symptoms and mild traumatic brain injury (MTBI) has already been demonstrated. It was defined as post-concussion syndrome (PCS) according to the DSM-IV-TR. However, several recent studies have shown that these symptoms are not specific to MTBI but may appear for any type of trauma and event for stressful medical conditions. PCS seems to appear for events occurring in a stressful environment or in people with psychological weaknesses. These symptoms will therefore be referred here to Post-concussion-like symptoms (PCLS). Moreover, PCLS appear to be very similar and sometime overlap those of the numbing and hyperarousal dimension of the Post Traumatic Stress Disorder (PTSD).
A recent study, carried out by our team in the ED of Bordeaux University Hospital, showed that PCLS was associated with a high level of stress at ED discharge, whatever that stress level at entry.
The Eye-Movement Desensitization and Reprocessing (EMDR) is a recognized psychotherapeutic approach in the treatment of PTSD and several single-session versions of the protocol have been proposed : one of them is Recent Traumatic Episode Protocol EMDR (R-TEP EMDR).The investigators hypothesize that the introduction of an early R-TEP EMDR intervention in emergencies can reduce the level of stress and thus the occurrence of the PCLS and PTSD symptoms among a subset of patients screened for their high risk of PCLS.
The study is a two-site open-label two-group randomized controlled trial designed to assess the efficacy of an early R-TEP EMDR intervention performed in the ED by comparing PCLS and PTSD symptoms at 3 and 12 months between the two randomization groups: (i) R-TEP EMDR; (ii) care as usual.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in this group continue their usual care without intervention. |
| R-TEP EMDR | Experimental | Behavioral: R-TEP EMDRPatients in R-TEP EMDR group will receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted in department (i) injured whatever the cause of injury. The event causing the injury must have occurred in the past 12 hours; or (ii) experiencing a medical event associated with a medical acute condition and presenting for the first time at the ED for this motive
- Score resulting from the screening tool>= 2 : Female gender: +1 Taking at least one anxiolytic treatment: + 1 Perceived health status prior to admission: Excellent, very good: 0 ; Good: +1 Poor: +2 ; Bad: +3
- Affiliated to French insurance system.
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability to answer questionnaire: any cognitive impairement, language barrier, consciousness disorder...
- Impossibility of recontacting the patient at a distance from the trauma (no telephone contact ...)
- Patient already included in the study.
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 EMDRRecent Traumatic Episode Protocol Eye-Movement Desensitization and Reprocessing is a early and short adaption protocol of EMDR developed by Shapiro E. EMDR is a psychotherapeutic approach that can rapidly process disturbing experiences adaptively together with the aid of eye movements or other forms of bi-lateral stimulation. | Behavioural | R-TEP EMDR |
Primary outcome
Compare the impact on 3-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP
Time frame: 3 months after inclusion visit
3-months PCLS as measured with the Rivermead Postconcussion Symptoms Questionnaire
6 secondary outcomes
Recovery expectation at discharge following participant' recruitment
Time frame: 3 months after inclusion visit
Acute pain
Time frame: 3 months after inclusion visit
Chronic pain
Time frame: 3 months after inclusion visit
Psychotropic medicines use
Time frame: 3 months after inclusion visit
Compare the impact on 12-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP.
Time frame: 12 months after inclusion visit
Compare the impact on 3-months Post-Traumatic Stress Disorder (PTSD) of early EMDR R-TEP.
Time frame: 3 months after inclusion visit
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 31 Jul 2019.
- Derived from this study: PubMed 30314512Gil-Jardine C, Al Joboory S, Jammes JTS, Durand G, Ribereau-Gayon R, Galinski M, Salmi LR, Revel P, Regis CA, Valdenaire G, Poulet E, Tazarourte K, Lagarde E. Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial. Trials. 2018 Oct 12;19(1):555. doi: 10.1186/s13063-018-2902-2.
- Individual participant dataSharing planned: Yes
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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, PhD study director
University Hospital Bordeaux, France
2 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 in people with Post-Concussion Symptoms and Post-Traumatic Stress Disorder, run by University Hospital, Bordeaux at 2 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 3 inclusion and 5 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Compare the impact on 3-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP (time frame: 3 months after inclusion visit). 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 NCT03400813, 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 31 Jul 2019.