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

Primary Purpose

Post-Traumatic Stress Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

standard

fixed

no focus

EMDR

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring standard, fixed, no focus, EMDR treatment with bilateral stimulation via eye movement, EMDR treatment with fixed eyes, Trauma exposition without external stimulus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Technische Universität MünchenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

standard

fixed

no focus

Arm Description

EMDR treatment with bilateral stimulation via eye movement

EMDR treatment with eyes fixed

trauma exposition without external stimulus

Outcomes

Primary Outcome Measures

CAPS-2: Clinical Administered PTSD Scale

Secondary Outcome Measures

IES - Impact of Events Scale

Full Information

NCT ID

NCT01209377

First Posted

June 17, 2010

Last Updated

September 24, 2010

Sponsor

Technical University of Munich

Collaborators

German Research Foundation, University of Giessen

1. Study Identification

Unique Protocol Identification Number

NCT01209377

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Unknown status

Study Start Date

April 2010 (undefined)

Primary Completion Date

January 2012 (Anticipated)

Study Completion Date

April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Technical University of Munich

Collaborators

German Research Foundation, University of Giessen

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Traumatic Stress Disorder

Keywords

standard, fixed, no focus, EMDR treatment with bilateral stimulation via eye movement, EMDR treatment with fixed eyes, Trauma exposition without external stimulus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

standard

Arm Type

Experimental

Arm Description

EMDR treatment with bilateral stimulation via eye movement

Arm Title

fixed

Arm Type

Experimental

Arm Description

EMDR treatment with eyes fixed

Arm Title

no focus

Arm Type

Experimental

Arm Description

trauma exposition without external stimulus

Intervention Type

Behavioral

Intervention Name(s)

standard

Intervention Description

EMDR treatment with bilateral stimulation via eye movement

Intervention Type

Behavioral

Intervention Name(s)

fixed

Intervention Description

EMDR treatment with fixed eyes

Intervention Type

Behavioral

Intervention Name(s)

no focus

Intervention Description

trauma exposure without external focus

Intervention Type

Procedure

Intervention Name(s)

EMDR

Intervention Description

Eye Movement Desensitization and Reprocessing (EMDR)

Primary Outcome Measure Information:

Title

CAPS-2: Clinical Administered PTSD Scale

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

IES - Impact of Events Scale

Time Frame

10 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martin Sack, MD

Phone

+498941404312

m.sack@tum.de

First Name & Middle Initial & Last Name or Official Title & Degree

Julia Körner, PHD

Phone

+498941406435

j.koerner@tum.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Sack, PHD

Organizational Affiliation

Technical University of Munich

Official's Role

Study Director

Facility Information:

Facility Name

Technische Universität München

City

Munich

ZIP/Postal Code

81675

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin Sack, MD

Phone

+498941404312

m.sack@tum.de

First Name & Middle Initial & Last Name & Degree

Julia Körner, PHD

Phone

+498941406435

j.koerner@tum.de

First Name & Middle Initial & Last Name & Degree

Martin Sack, MD

First Name & Middle Initial & Last Name & Degree

Julia Körner, PHD

12. IPD Sharing Statement

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

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