Eye-Movement Desensitization and Reprocessing in the ED and Post-Traumatic Syndrome (EMDR-ED)
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Reassurance
Eye-Movement Desensitization and Reprocessing (EMDR)
Sponsored by
About this trial
This is an interventional prevention trial for Post-Traumatic Stress Disorder focused on measuring Post-Traumatic Syndrome, Eye-Movement Desensitization and Reprocessing
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Emergency department, Bordeaux University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
Control
Reassurance
R-TEP EMDR
Arm Description
usual care
15 minutes psychologist visit
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
Outcomes
Primary Outcome Measures
EMDR protocol completion
Eye-Movement Desensitization and Reprocessing, performed in a population with high risk of PTS at the Emergency Department thanks to questionnaires
Secondary Outcome Measures
Recovery rate
3 months after ED admission
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.
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.
Chronic Pain at 3 months
Self reported by phone
Full Information
NCT ID
NCT03194386
First Posted
March 24, 2017
Last Updated
January 9, 2018
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT03194386
Brief Title
Eye-Movement Desensitization and Reprocessing in the ED and Post-Traumatic Syndrome
Acronym
EMDR-ED
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Post-Traumatic Syndrome, Eye-Movement Desensitization and Reprocessing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Investigator / Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
usual care
Arm Title
Reassurance
Arm Type
Active Comparator
Arm Description
15 minutes psychologist visit
Arm Title
R-TEP EMDR
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Reassurance
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Eye-Movement Desensitization and Reprocessing (EMDR)
Intervention Description
At the end of cares, before ED discharge, a trained psychologist will conduct a single EMDR session. Each session may last about 60 minutes
Primary Outcome Measure Information:
Title
EMDR protocol completion
Description
Eye-Movement Desensitization and Reprocessing, performed in a population with high risk of PTS at the Emergency Department thanks to questionnaires
Time Frame
12 hours after ED admission
Secondary Outcome Measure Information:
Title
Recovery rate
Description
3 months after ED admission
Time Frame
3 months
Title
Post-concussion Syndrome
Description
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.
Time Frame
3 months after ED admission
Title
Post-Traumatic Stress Disorder
Description
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.
Time Frame
3 months after ED admission
Title
Chronic Pain at 3 months
Description
Self reported by phone
Time Frame
3 months after ED admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Lagarde, PhD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Study Director
Facility Information:
Facility Name
Emergency department, Bordeaux University Hospital
City
Bordeaux
ZIP/Postal Code
33076
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
29894921
Citation
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.
Results Reference
derived
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Eye-Movement Desensitization and Reprocessing in the ED and Post-Traumatic Syndrome
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