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

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)

Official Title
-----------------
Randomized Controlled Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism

Conditions
-----------------
Post-Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: standard
* Behavioral: fixed
* Behavioral: no focus
* Procedure: EMDR


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard<br>EMDR treatment with bilateral stimulation via eye movement | Behavioral: standard<br>* EMDR treatment with bilateral stimulation via eye movement<br>Procedure: EMDR<br>* Eye Movement Desensitization and Reprocessing (EMDR)<br>|
| Experimental: fixed<br>EMDR treatment with eyes fixed | Behavioral: fixed<br>* EMDR treatment with fixed eyes<br>Procedure: EMDR<br>* Eye Movement Desensitization and Reprocessing (EMDR)<br>|
| Experimental: no focus<br>trauma exposition without external stimulus | Behavioral: no focus<br>* trauma exposure without external focus<br>Procedure: EMDR<br>* Eye Movement Desensitization and Reprocessing (EMDR)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAPS-2: Clinical Administered PTSD Scale |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IES - Impact of Events Scale |  | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
standard, fixed, no focus, EMDR treatment with bilateral stimulation via eye movement, EMDR treatment with fixed eyes, Trauma exposition without external stimulus