Randomized Controlled Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 192
- Locations
- 2
- Primary Endpoint
- CAPS-2: Clinical Administered PTSD Scale
Study Overview
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:
- 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)
- 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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
CAPS-2: Clinical Administered PTSD Scale
Time Frame: 30 minutes
Secondary Outcomes
- IES - Impact of Events Scale(10 minutes)
