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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Technische Universität München.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
German Research Foundation
University of Giessen
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01209377
First received: June 17, 2010
Last updated: September 24, 2010
Last verified: September 2010
  Purpose

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 Intervention
Post-Traumatic Stress Disorder
Behavioral: standard
Behavioral: fixed
Behavioral: no focus
Procedure: EMDR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • CAPS-2: Clinical Administered PTSD Scale [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IES - Impact of Events Scale [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: April 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: standard
EMDR treatment with bilateral stimulation via eye movement
Behavioral: standard
EMDR treatment with bilateral stimulation via eye movement
Other Name: standard
Procedure: EMDR
Eye Movement Desensitization and Reprocessing (EMDR)
Experimental: fixed
EMDR treatment with eyes fixed
Behavioral: fixed
EMDR treatment with fixed eyes
Other Name: fixed
Procedure: EMDR
Eye Movement Desensitization and Reprocessing (EMDR)
Experimental: no focus
trauma exposition without external stimulus
Behavioral: no focus
trauma exposure without external focus
Other Name: no focus
Procedure: EMDR
Eye Movement Desensitization and Reprocessing (EMDR)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209377

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

Locations
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
Technische Universität München
German Research Foundation
University of Giessen
Investigators
Study Director: Martin Sack, PHD Technische Universität München
  More Information

No publications provided

Responsible Party: Martin Sack, MD, Technical University of Munich
ClinicalTrials.gov Identifier: NCT01209377     History of Changes
Other Study ID Numbers: SA1475/2-1
Study First Received: June 17, 2010
Last Updated: September 24, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
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:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 21, 2014