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

NCT01209377 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2010-09-27

No results posted yet for this study

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)

Conditions

  • Post-Traumatic Stress Disorder

Interventions

BEHAVIORAL

standard

EMDR treatment with bilateral stimulation via eye movement

BEHAVIORAL

fixed

EMDR treatment with fixed eyes

BEHAVIORAL

no focus

trauma exposure without external focus

PROCEDURE

EMDR

Eye Movement Desensitization and Reprocessing (EMDR)

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER
  • University of Giessen

    collaborator OTHER
  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Martin Sack, PHD · Technical University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-01-31
Completion
2012-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01209377 on ClinicalTrials.gov