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

NCT03194386 | Completed

• 1 other identifier: 2017/01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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-Traumatic Stress Disorder

Keywords

Post-Traumatic Syndrome; Eye-Movement Desensitization and Reprocessing

Outcome Measures

Primary Outcomes (1)

• EMDR protocol completion

  Eye-Movement Desensitization and Reprocessing, performed in a population with high risk of PTS at the Emergency Department thanks to questionnaires

  12 hours after ED admission

Secondary Outcomes (4)

• Recovery rate

  3 months

• Post-concussion Syndrome

  3 months after ED admission

• Post-Traumatic Stress Disorder

  3 months after ED admission

• Chronic Pain at 3 months

  3 months after ED admission

Study Arms (3)

Control

NO INTERVENTION

usual care

Reassurance

ACTIVE COMPARATOR

15 minutes psychologist visit

Other: Reassurance

R-TEP EMDR

EXPERIMENTAL

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

Other: Eye-Movement Desensitization and Reprocessing (EMDR)

Interventions

Reassurance OTHER

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.

Reassurance

Eye-Movement Desensitization and Reprocessing (EMDR) OTHER

At the end of cares, before ED discharge, a trained psychologist will conduct a single EMDR session. Each session may last about 60 minutes

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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Emergency department, Bordeaux University Hospital

Bordeaux, 33076, France

Location

Related Publications (1)

• 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.

  PMID: 29894921 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Emmanuel Lagarde, PhD

  University Hospital Bordeaux, France

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: June 21, 2017
• Study Start: October 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 11, 2018

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)