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Clinical Trials/NCT01209377
NCT01209377UnknownNot Applicable

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

Technical University of Munich2 sites in 1 country192 target enrollmentStarted: April 1, 2010Last updated:
Conditions

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:

  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)

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)

Investigators

Sponsor
Technical University of Munich
Sponsor Class
Other

Study Sites (2)

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