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

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ClinicalTrials.gov Identifier: NCT01209377
Recruitment Status : Unknown
Verified September 2010 by Technical University of Munich.
Recruitment status was:  Recruiting
First Posted : September 27, 2010
Last Update Posted : September 27, 2010
Sponsor:
Collaborators:
German Research Foundation
University of Giessen
Information provided by:
Technical University of Munich

Study Description
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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)

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Behavioral: standard Behavioral: fixed Behavioral: no focus Procedure: EMDR Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism
Study Start Date : April 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : April 2012
Arms and Interventions
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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
 Behavioral: fixed
EMDR treatment with fixed eyes

Procedure: EMDR
Eye Movement Desensitization and Reprocessing (EMDR)
Experimental: no focus
trauma exposition without external stimulus
 Behavioral: no focus
trauma exposure without external focus

Procedure: EMDR
Eye Movement Desensitization and Reprocessing (EMDR)


Outcome Measures
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Primary Outcome Measures :
  1. CAPS-2: Clinical Administered PTSD Scale [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. IES - Impact of Events Scale [ Time Frame: 10 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209377


Contacts
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Contact: Martin Sack, MD +498941404312 m.sack@tum.de
Contact: Julia Körner, PHD +498941406435 j.koerner@tum.de

Locations
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Germany
Technische Universität München Recruiting
Munich, Germany, 81675
Contact: Martin Sack, MD    +498941404312    m.sack@tum.de   
Contact: Julia Körner, PHD    +498941406435    j.koerner@tum.de   
Principal Investigator: Martin Sack, MD         
Sub-Investigator: Julia Körner, PHD         
Sponsors and Collaborators
Technical University of Munich
German Research Foundation
University of Giessen
Investigators
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Study Director: Martin Sack, PHD Technical University of Munich
More Information
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Responsible Party: Martin Sack, MD, Technical University of Munich
ClinicalTrials.gov Identifier: NCT01209377    
Other Study ID Numbers: SA1475/2-1
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: September 27, 2010
Last Verified: September 2010
Keywords provided by Technical University of Munich:
standard
fixed
no focus
 EMDR treatment with bilateral stimulation via eye movement
EMDR treatment with fixed eyes
Trauma exposition without external stimulus
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders