NCT01209377

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. 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. 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

September 27, 2010

Status Verified

September 1, 2010

Enrollment Period

1.8 years

First QC Date

June 17, 2010

Last Update Submit

September 24, 2010

Conditions

Post-Traumatic Stress Disorder

Keywords

standardfixedno focusEMDR treatment with bilateral stimulation via eye movementEMDR treatment with fixed eyesTrauma exposition without external stimulus

Outcome Measures

Primary Outcomes (1)

  • CAPS-2: Clinical Administered PTSD Scale

    30 minutes

Secondary Outcomes (1)

  • IES - Impact of Events Scale

    10 minutes

Study Arms (3)

standard

EXPERIMENTAL

EMDR treatment with bilateral stimulation via eye movement

Behavioral: standardProcedure: EMDR

fixed

EXPERIMENTAL

EMDR treatment with eyes fixed

Behavioral: fixedProcedure: EMDR

no focus

EXPERIMENTAL

trauma exposition without external stimulus

Behavioral: no focusProcedure: EMDR

Interventions

standardBEHAVIORAL

EMDR treatment with bilateral stimulation via eye movement

standard
fixedBEHAVIORAL

EMDR treatment with fixed eyes

fixed
no focusBEHAVIORAL

trauma exposure without external focus

no focus
EMDRPROCEDURE

Eye Movement Desensitization and Reprocessing (EMDR)

fixedno focusstandard

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the participant is able to reduce stress symptoms
  • no actual contact to offender

You may not qualify if:

  • drug or alcohol addiction
  • inability to tell about the traumatic events
  • cardiac problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technische Universität München

Munich, Germany, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Martin Sack, PHD

    Technical University of Munich

    STUDY DIRECTOR

Central Study Contacts

Martin Sack, MD

CONTACT

+498941404312m.sack@tum.de

Julia Körner, PHD

CONTACT

+498941406435j.koerner@tum.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2010

First Posted

September 27, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2012

Study Completion

April 1, 2012

Last Updated

September 27, 2010

Record last verified: 2010-09

Locations

DE(1)