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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01209377
• Other study ID #: SA1475/2-1
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2010
• Last updated: September 24, 2010
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: September 2010
• Source: Technische Universität München
• Contact: Martin Sack, MD
• Phone: +498941404312
• Email: m.sack[@]tum.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• standard
EMDR treatment with bilateral stimulation via eye movement
• fixed
EMDR treatment with fixed eyes
• no focus
trauma exposure without external focus

Procedure:
• EMDR
Eye Movement Desensitization and Reprocessing (EMDR)

Locations

Country	Name	City	State
Germany	Technische Universität München	Munich

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität München	German Research Foundation, University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAPS-2: Clinical Administered PTSD Scale		30 minutes	No
Secondary	IES - Impact of Events Scale		10 minutes	No