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

T

Technical University of Munich

Status

Unknown

Conditions

Post-Traumatic Stress Disorder

Treatments

Procedure: EMDR
Behavioral: fixed
Behavioral: standard
Behavioral: no focus

Study type

Interventional

Funder types

Other

Identifiers

NCT01209377
SA1475/2-1

Details and patient eligibility

About

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)

Enrollment

192 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

192 participants in 3 patient groups

standard
Experimental group
Description:
EMDR treatment with bilateral stimulation via eye movement
Treatment:
Procedure: EMDR
Behavioral: standard
fixed
Experimental group
Description:
EMDR treatment with eyes fixed
Treatment:
Procedure: EMDR
Behavioral: fixed
no focus
Experimental group
Description:
trauma exposition without external stimulus
Treatment:
Procedure: EMDR
Behavioral: no focus

Trial contacts and locations

1

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Central trial contact

Martin Sack, MD; Julia Körner, PHD

Data sourced from clinicaltrials.gov

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