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

NCT ID: NCT01209377

Last Updated: 2010-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-04-30

Brief Summary

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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)

Detailed Description

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Conditions

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Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard

EMDR treatment with bilateral stimulation via eye movement

Group Type EXPERIMENTAL

standard

Intervention Type BEHAVIORAL

EMDR treatment with bilateral stimulation via eye movement

EMDR

Intervention Type PROCEDURE

Eye Movement Desensitization and Reprocessing (EMDR)

fixed

EMDR treatment with eyes fixed

Group Type EXPERIMENTAL

fixed

Intervention Type BEHAVIORAL

EMDR treatment with fixed eyes

EMDR

Intervention Type PROCEDURE

Eye Movement Desensitization and Reprocessing (EMDR)

no focus

trauma exposition without external stimulus

Group Type EXPERIMENTAL

no focus

Intervention Type BEHAVIORAL

trauma exposure without external focus

EMDR

Intervention Type PROCEDURE

Eye Movement Desensitization and Reprocessing (EMDR)

Interventions

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standard

EMDR treatment with bilateral stimulation via eye movement

Intervention Type BEHAVIORAL

fixed

EMDR treatment with fixed eyes

Intervention Type BEHAVIORAL

no focus

trauma exposure without external focus

Intervention Type BEHAVIORAL

EMDR

Eye Movement Desensitization and Reprocessing (EMDR)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

University of Giessen

OTHER

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Technical University of Munich

Principal Investigators

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Martin Sack, PHD

Role: STUDY_DIRECTOR

Technical University of Munich

Locations

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Technische Universität München

Munich, Germany, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Martin Sack, MD

Role: CONTACT

+498941404312

Julia Körner, PHD

Role: CONTACT

+498941406435

Facility Contacts

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Martin Sack, MD

Role: primary

+498941404312

Julia Körner, PHD

Role: backup

+498941406435

Other Identifiers

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SA1475/2-1

Identifier Type: -

Identifier Source: org_study_id