Post-Traumatic Stress Disorder Clinical Trial
Official title:
Randomized Controlled Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism
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)
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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