Eye-Movement Desensitization and Post-Traumatic Syndroms (SOFTER3)
Primary Purpose
Post-Concussion Symptoms, Post-Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
R-TEP EMDR
Sponsored by
About this trial
This is an interventional prevention trial for Post-Concussion Symptoms focused on measuring Eye-Movement Desensitization, Reprocessing
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Emergency department, Bordeaux University Hospital
- University Hospital, Lyon
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
R-TEP EMDR
Arm Description
Patients in this group continue their usual care without intervention.
Patients in R-TEP EMDR group will receive the intervention.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Recovery expectation at discharge following participant' recruitment
Self-reported to ER medical staff thanks to a Rivermead questionnaire
Acute pain
Self-reported acute pain to ER medical staff using the total score of a 10 points Likert scale
Chronic pain
chronic pain will be self-reported thanks to a Rivermead questionnaire
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.
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
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
Full Information
NCT ID
NCT03400813
First Posted
November 20, 2017
Last Updated
July 30, 2019
Sponsor
University Hospital, Bordeaux
Collaborators
Centre Hospitalier de Cadillac, France, Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03400813
Brief Title
Eye-Movement Desensitization and Post-Traumatic Syndroms
Acronym
SOFTER3
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
July 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Centre Hospitalier de Cadillac, France, Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Symptoms, Post-Traumatic Stress Disorder
Keywords
Eye-Movement Desensitization, Reprocessing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator / Outcomes Assessor
Allocation
Randomized
Enrollment
314 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in this group continue their usual care without intervention.
Arm Title
R-TEP EMDR
Arm Type
Experimental
Arm Description
Patients in R-TEP EMDR group will receive the intervention.
Intervention Type
Behavioral
Intervention Name(s)
R-TEP EMDR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compare the impact on 3-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP
Description
3-months PCLS as measured with the Rivermead Postconcussion Symptoms Questionnaire
Time Frame
3 months after inclusion visit
Secondary Outcome Measure Information:
Title
Recovery expectation at discharge following participant' recruitment
Description
Self-reported to ER medical staff thanks to a Rivermead questionnaire
Time Frame
3 months after inclusion visit
Title
Acute pain
Description
Self-reported acute pain to ER medical staff using the total score of a 10 points Likert scale
Time Frame
3 months after inclusion visit
Title
Chronic pain
Description
chronic pain will be self-reported thanks to a Rivermead questionnaire
Time Frame
3 months after inclusion visit
Title
Psychotropic medicines use
Description
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.
Time Frame
3 months after inclusion visit
Title
Compare the impact on 12-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP.
Description
12-months PCLS as measured with the the Rivermead Postconcussion Symptoms Questionnaire
Time Frame
12 months after inclusion visit
Title
Compare the impact on 3-months Post-Traumatic Stress Disorder (PTSD) of early EMDR R-TEP.
Description
3-months PTSD as measured with PTSD Checklist-5
Time Frame
3 months after inclusion visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Facility Name
University Hospital, Lyon
City
Lyon
ZIP/Postal Code
69000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
30314512
Citation
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.
Results Reference
derived
Learn more about this trial
Eye-Movement Desensitization and Post-Traumatic Syndroms
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