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Eye-Movement Desensitization and Post-Traumatic Syndroms (SOFTER3)

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ClinicalTrials.gov Identifier: NCT03400813
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
Centre Hospitalier de Cadillac, France
Hospices Civils de Lyon
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Post-Concussion Symptoms Post-Traumatic Stress Disorder Behavioral: R-TEP EMDR Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigator / Outcomes Assessor
Primary Purpose: Prevention
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
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : July 15, 2019

Arm Intervention/treatment
No Intervention: Control
Patients in this group continue their usual care without intervention.
Experimental: R-TEP EMDR
Patients in R-TEP EMDR group will receive the intervention.
Behavioral: R-TEP EMDR
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 Measures :
  1. 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


Secondary Outcome Measures :
  1. Recovery expectation at discharge following participant' recruitment [ Time Frame: 3 months after inclusion visit ]
    Self-reported to ER medical staff thanks to a Rivermead questionnaire

  2. Acute pain [ Time Frame: 3 months after inclusion visit ]
    Self-reported acute pain to ER medical staff using the total score of a 10 points Likert scale

  3. Chronic pain [ Time Frame: 3 months after inclusion visit ]
    chronic pain will be self-reported thanks to a Rivermead questionnaire

  4. Psychotropic medicines use [ Time Frame: 3 months after inclusion visit ]
    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.

  5. Compare the impact on 12-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP. [ Time Frame: 12 months after inclusion visit ]
    12-months PCLS as measured with the the Rivermead Postconcussion Symptoms Questionnaire

  6. Compare the impact on 3-months Post-Traumatic Stress Disorder (PTSD) of early EMDR R-TEP. [ Time Frame: 3 months after inclusion visit ]
    3-months PTSD as measured with PTSD Checklist-5



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400813


Locations
France
Emergency department, Bordeaux University Hospital
Bordeaux, France, 33076
University Hospital, Lyon
Lyon, France, 69000
Sponsors and Collaborators
University Hospital, Bordeaux
Centre Hospitalier de Cadillac, France
Hospices Civils de Lyon
Investigators
Study Director: Emmanuel Lagarde, PhD University Hospital Bordeaux, France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03400813     History of Changes
Other Study ID Numbers: CHUBX 2017/13
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Eye-Movement Desensitization
Reprocessing

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Post-Concussion Syndrome
Trauma and Stressor Related Disorders
Mental Disorders
Brain Concussion
Head Injuries, Closed
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Wounds, Nonpenetrating