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Eye-Movement Desensitization and Reprocessing in the ED and Post-Traumatic Syndrome (EMDR-ED)

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ClinicalTrials.gov Identifier: NCT03194386
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE March 24, 2017
First Posted Date  ICMJE June 21, 2017
Last Update Posted Date January 11, 2018
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
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
Change History Complete list of historical versions of study NCT03194386 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
  • Recovery rate [ Time Frame: 3 months ]
    3 months after ED admission
  • Post-concussion Syndrome [ Time Frame: 3 months after ED admission ]
    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 [ Time Frame: 3 months after ED admission ]
    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 [ Time Frame: 3 months after ED admission ]
    Self reported by phone
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eye-Movement Desensitization and Reprocessing in the ED and Post-Traumatic Syndrome
Official Title  ICMJE Feasibility and Interest of Early Eye-Movement Desensitization and Reprocessing Provided in the Emergency Department for Patients With High Risk of Post Traumatic Syndrome
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description:
Investigator / Outcomes Assessor
Primary Purpose: Prevention
Condition  ICMJE Post-Traumatic Stress Disorder
Intervention  ICMJE
  • Other: Reassurance
    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.
  • Other: 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
Study Arms  ICMJE
  • No Intervention: Control
    usual care
  • Active Comparator: Reassurance
    15 minutes psychologist visit
    Intervention: Other: Reassurance
  • Experimental: R-TEP 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
    Intervention: Other: Eye-Movement Desensitization and Reprocessing (EMDR)
Publications * Gil-Jardiné C, Evrard G, Al Joboory S, Tortes Saint Jammes J, Masson F, Ribéreau-Gayon R, Galinski M, Salmi LR, Revel P, Régis 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2017)
110
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03194386
Other Study ID Numbers  ICMJE 2017/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Emmanuel Lagarde, PhD University Hospital Bordeaux, France
PRS Account University Hospital, Bordeaux
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP