Eye-Movement Desensitization and Post-Traumatic Syndroms

NCT03400813 | Completed DMC

• 1 other identifier: CHUBX 2017/13
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-Concussion Symptoms; Post-Traumatic Stress Disorder

Keywords

Eye-Movement Desensitization; Reprocessing

Outcome Measures

Primary Outcomes (1)

• 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

  3 months after inclusion visit

Secondary Outcomes (6)

• Recovery expectation at discharge following participant' recruitment

  3 months after inclusion visit

• Acute pain

  3 months after inclusion visit

• Chronic pain

  3 months after inclusion visit

• Psychotropic medicines use

  3 months after inclusion visit

• Compare the impact on 12-months PostConcussion-Like Syndrome (PCLS) of early Early EMDR R-TEP.

  12 months after inclusion visit

Study Arms (2)

Control

NO INTERVENTION

Patients in this group continue their usual care without intervention.

R-TEP EMDR

EXPERIMENTAL

Patients in R-TEP EMDR group will receive the intervention.

Behavioral: R-TEP EMDR

Interventions

R-TEP EMDR BEHAVIORAL

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.

R-TEP EMDR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Centre Hospitalier de Cadillac: collaborator
• Hospices Civils de Lyon: collaborator

Study Sites (2)

Emergency department, Bordeaux University Hospital

Bordeaux, 33076, France

Location

University Hospital, Lyon

Lyon, 69000, France

Location

Related Publications (1)

• 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.

  PMID: 30314512 DERIVED

MeSH Terms

Conditions

Post-Concussion Syndrome; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Emmanuel Lagarde, PhD

  University Hospital Bordeaux, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator / Outcomes Assessor
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: January 17, 2018
• Study Start: January 15, 2018
• Primary Completion: October 31, 2018
• Study Completion: July 15, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (2)