Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism

Randomized Controlled Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism

EMDR (Eye Movement Desensitization and Reprocessing) is an exposure-based procedure for the treatment of patients with post-traumatic stress disorder (PTSD). Although the efficiency of EMDR-treatment is empirically proven, it remains unclear whether the bilateral stimulation triggered via eye movements has specific effects on treatment outcome. Hypothesis explaining the efficacy of the EMDR treatment are: focussing on the moving hand triggers an orientation reaction, and the duality of alertness focus during trauma exposition causes a distraction of the traumatic topic.

Within a randomized controlled study 120 patients will be treated during 8 therapeutical sessions with EMDR with bilateral stimulation or one of two control conditions: EMDR without bilateral stimulation (eyes on a fixed, unmoving hand) and exposition without any visual stimuli to focus attention on. Primary outcome are scores on an interview measure for PTSD symptoms (Clinician Administered PTSD Scale (CAPS))as assessed pre-treatment and after treatment (max 8 sessions of psychotherapy).

The following hypothesis are investigated in the study:

1. EMDR treatment with bilateral stimulation through eye movements will be followed significant larger reduction in CAPS compared with EMDR treatment without bilateral stimulation (specific treatment effect of eye movements)
2. EMDR with eyes fixed will be followed by a significant larger reduction in CAPS compared with EMDR without external focus (specific treatment effect of distraction)

Study Overview

• Status: Unknown
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: standard; Procedure: EMDR; Behavioral: fixed; Behavioral: no focus

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Sack, MD; Phone Number: +498941404312; Email: m.sack@tum.de
• Study Contact Backup: Name: Julia Körner, PHD; Phone Number: +498941406435; Email: j.koerner@tum.de

Study Locations

• Germany
  • Munich, Germany, 81675
    • Recruiting
    • Technische Universität München
    • Contact: Martin Sack, MD; Phone Number: +498941404312; Email: m.sack@tum.de
    • Contact: Julia Körner, PHD; Phone Number: +498941406435; Email: j.koerner@tum.de
    • Principal Investigator: Martin Sack, MD
    • Sub-Investigator: Julia Körner, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• the participant is able to reduce stress symptoms
• no actual contact to offender

Exclusion Criteria:

• drug or alcohol addiction
• inability to tell about the traumatic events
• cardiac problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard; EMDR treatment with bilateral stimulation via eye movement	Behavioral: standard; EMDR treatment with bilateral stimulation via eye movement; Procedure: EMDR; Eye Movement Desensitization and Reprocessing (EMDR)
Experimental: fixed; EMDR treatment with eyes fixed	Procedure: EMDR; Eye Movement Desensitization and Reprocessing (EMDR); Behavioral: fixed; EMDR treatment with fixed eyes
Experimental: no focus; trauma exposition without external stimulus	Procedure: EMDR; Eye Movement Desensitization and Reprocessing (EMDR); Behavioral: no focus; trauma exposure without external focus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CAPS-2: Clinical Administered PTSD Scale	30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
IES - Impact of Events Scale	10 minutes

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: German Research Foundation; University of Giessen
• Investigators: Study Director: Martin Sack, PHD, Technical University of Munich

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: June 17, 2010
• First Submitted That Met QC Criteria: September 24, 2010
• First Posted (Estimate): September 27, 2010

Study Record Updates

• Last Update Posted (Estimate): September 27, 2010
• Last Update Submitted That Met QC Criteria: September 24, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: fixed; standard; no focus; EMDR treatment with bilateral stimulation via eye movement; EMDR treatment with fixed eyes; Trauma exposition without external stimulus
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: SA1475/2-1