Post-Traumatic Stress DisorderEMDR-EDNCT03194386
Eye-Movement Desensitization and Reprocessing in the ED and Post-Traumatic Syndrome
A study testing Reassurance and Eye-Movement Desensitization and Reprocessing (EMDR) in people with Post-Traumatic Stress Disorder, run by University Hospital, Bordeaux at 1 site 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-Traumatic Stress Disorder
- What is being tested?
- Reassurance and Eye-Movement Desensitization and Reprocessing (EMDR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Jun 2017
- 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 for a medical or traumatic event, and at risk of developing a PTS.
- Score resulting from the screening tool> 3 :
- 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 Social Security
Who cannot join
- Refusal to participate in the study
- Admission and / or exit questionnaire not completed
- 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
1 site in 1 country.
France1 site
Emergency department, Bordeaux University Hospital
Bordeaux, 33076
About this study
Official title: Feasibility and Interest of Early Eye-Movement Desensitization and Reprocessing Provided in the Emergency Department for Patients With High Risk of Post Traumatic Syndrome
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 room (ER). 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 PCS-like syndrome (PCSLS). Moreover, PCS-LS symptoms appear to be very similar to 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 PCS-LS 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 (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 PCSLS and PTSD symptoms among a subset of patients screened for their high risk of PCS-LS.
The study is a single-site open-label three-group randomized controlled trial designed to assess the feasibility of an early R-TEP EMDR intervention performed in the ED and to compare PCS-LS and PTSD symptoms at 3 months between the three randomization groups: (i) TEP-EMDR; (ii) 15' reassurance session; (iii) care as usual.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Reassurance, Eye-Movement Desensitization and Reprocessing (EMDR)
- Keywords
- Post-Traumatic Syndrome, Eye-Movement Desensitization and Reprocessing
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReassuranceOther
At the end of cares, before ED discharge, a trained psychologist will conduct a session in order to reassure patients about their future after ED visit.
Eye-Movement Desensitization and Reprocessing (EMDR)Other
At the end of cares, before ED discharge, a trained psychologist will conduct a single EMDR session. Each session may last about 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | usual care |
| Reassurance | Active comparator | 15 minutes psychologist visit Receives: Other: Reassurance |
| R-TEP EMDR | Experimental | Recent Traumatic Episode Protocol Eye-Movement Desensitization and Reprocessing (R-TEP EMDR) At the end of cares, before ED discharge, a trained psychologist will conduct a single R-TEP EMDR session. Each session may last about 60 minutes Receives: Other: Eye-Movement Desensitization and Reprocessing (EMDR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMDR protocol completion
Eye-Movement Desensitization and Reprocessing, performed in a population with high risk of PTS at the Emergency Department thanks to questionnaires
Measured: 12 hours after ED admission
Secondary outcomes (4)
Recovery rate
3 months after ED admission
Measured: 3 months
Post-concussion Syndrome
Post-Concussion Syndrome (PCS) was assessed using the various definitions of PCS (ICD-10, DSM IV and Rivermaid) were selected: headache, feelings of dizziness, nausea or vomiting, noise sensitivity, sleeping disorders, fatigue, irritability, feeling depressed, anxiety, intolerance to stress, feeling frustrated or impatient, forgetfulness or poor memory, poor concentration, taking longer to think, blurred vision, double vision, light sensitivity, restlessness, personality change. In line with PCS definition in the context of mild head injury, we defined patients with PCS as those who reported at least 3 of these symptoms.
Measured: 3 months after ED admission
Post-Traumatic Stress Disorder
Post-Traumatic Stress Disorder was defined using the PTSD Check-List Scale. The presence of the 17 symptoms of the DSM-IV-R definition for PTSD were also assessed for the 3-month phone The diagnosis of PTSD requires that one or more symptoms from each of those categories be present for at least a month and that those symptoms interfere seriously with leading a normal life.
Measured: 3 months after ED admission
Chronic Pain at 3 months
Self reported by phone
Measured: 3 months after ED admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study startOct 2016
- Primary completionApr 2017
- Study completionJun 2017
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-Traumatic Stress DisorderStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Lagarde, PhD, Study director, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194386
- Sponsor's protocol ID
- 2017/01
- Acronym
- EMDR-ED
- Status last verified
- Jun 2017
- First submitted
- 24 Mar 2017
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gil-Jardine C, Evrard G, Al Joboory S, Tortes Saint Jammes J, Masson F, Ribereau-Gayon R, Galinski M, Salmi LR, Revel P, Regis CA, Valdenaire G, Lagarde E. Emergency room intervention to prevent post concussion-like symptoms and post-traumatic stress disorder. A pilot randomized controlled study of a brief eye movement desensitization and reprocessing intervention versus reassurance or usual care. J Psychiatr Res. 2018 Aug;103:229-236. doi: 10.1016/j.jpsychires.2018.05.024. Epub 2018 May 26.
PubMed 29894921
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Interest of Early Eye-Movement Desensitization and Reprocessing Provided in the Emergency Department for Patients With High Risk of Post Traumatic Syndrome
- ClinicalTrials.gov ID
- NCT03194386
- Acronym / sponsor ID
- EMDR-ED / 2017/01
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Post-Traumatic Syndrome, Eye-Movement Desensitization and Reprocessing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Jun 2017 (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 room (ER). 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 PCS-like syndrome (PCSLS). Moreover, PCS-LS symptoms appear to be very similar to 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 PCS-LS 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 (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 PCSLS and PTSD symptoms among a subset of patients screened for their high risk of PCS-LS.
The study is a single-site open-label three-group randomized controlled trial designed to assess the feasibility of an early R-TEP EMDR intervention performed in the ED and to compare PCS-LS and PTSD symptoms at 3 months between the three randomization groups: (i) TEP-EMDR; (ii) 15' reassurance session; (iii) care as usual.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –usual care |
| Reassurance | Active comparator | Other: Reassurance15 minutes psychologist visit |
| R-TEP EMDR | Experimental | Other: Eye-Movement Desensitization and Reprocessing (EMDR)Recent Traumatic Episode Protocol Eye-Movement Desensitization and Reprocessing (R-TEP EMDR) At the end of cares, before ED discharge, a trained psychologist will conduct a single R-TEP EMDR session. Each session may last about 60 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted in department for a medical or traumatic event, and at risk of developing a PTS.
- Score resulting from the screening tool> 3 :
- 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 Social Security
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- Admission and / or exit questionnaire not completed
- 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 |
|---|---|---|
| ReassuranceAt the end of cares, before ED discharge, a trained psychologist will conduct a session in order to reassure patients about their future after ED visit. | Other | Reassurance |
| Eye-Movement Desensitization and Reprocessing (EMDR)At the end of cares, before ED discharge, a trained psychologist will conduct a single EMDR session. Each session may last about 60 minutes | Other | R-TEP EMDR |
Primary outcome
EMDR protocol completion
Time frame: 12 hours after ED admission
Eye-Movement Desensitization and Reprocessing, performed in a population with high risk of PTS at the Emergency Department thanks to questionnaires
4 secondary outcomes
Recovery rate
Time frame: 3 months
Post-concussion Syndrome
Time frame: 3 months after ED admission
Post-Traumatic Stress Disorder
Time frame: 3 months after ED admission
Chronic Pain at 3 months
Time frame: 3 months after ED admission
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 11 Jun 2026.
- Results publication: PubMed 29894921Gil-Jardine C, Evrard G, Al Joboory S, Tortes Saint Jammes J, Masson F, Ribereau-Gayon R, Galinski M, Salmi LR, Revel P, Regis CA, Valdenaire G, Lagarde E. Emergency room intervention to prevent post concussion-like symptoms and post-traumatic stress disorder. A pilot randomized controlled study of a brief eye movement desensitization and reprocessing intervention versus reassurance or usual care. J Psychiatr Res. 2018 Aug;103:229-236. doi: 10.1016/j.jpsychires.2018.05.024. Epub 2018 May 26.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reassurance and Eye-Movement Desensitization and Reprocessing (EMDR) in people with Post-Traumatic Stress Disorder, run by University Hospital, Bordeaux at 1 site 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 4 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
EMDR protocol completion (time frame: 12 hours after ED admission). 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 NCT03194386, 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 11 Jun 2026.