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

Not Applicable

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Behavioral: fixed; Behavioral: no focus; Behavioral: standard; Procedure: EMDR

• Registration Number: NCT01209377
• Lead Sponsor: Technical University of Munich

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-17
• Status Verified: 2010-09
• Study First Submitted QC: 2010-09-24
• Last Update Submitted: 2010-09-24
• Study First Posted: 2010-09-27
• Last Update Posted: 2010-09-27
• Primary Completion: 2012-01
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
standard	EMDR	EMDR treatment with bilateral stimulation via eye movement
fixed	fixed	EMDR treatment with eyes fixed
no focus	no focus	trauma exposition without external stimulus
no focus	EMDR	trauma exposition without external stimulus
standard	standard	EMDR treatment with bilateral stimulation via eye movement
fixed	EMDR	EMDR treatment with eyes fixed

Primary Outcome Measures

Name	Time	Method
CAPS-2: Clinical Administered PTSD Scale	30 minutes

Secondary Outcome Measures

Name	Time	Method
IES - Impact of Events Scale	10 minutes

Trial Locations

Locations (1)

Technische Universität München; 🇩🇪 Munich, Germany