Trauma-focused CBT Versus EMDR in the Treatment of Posttraumatic Stress Disorder

This study is currently recruiting participants.

Verified September 2011 by VU University of Amsterdam

Sponsor:

Information provided by (Responsible Party):

Paul M.G.Emmelkamp, VU University of Amsterdam

ClinicalTrials.gov Identifier:

NCT00716638

First received: July 14, 2008

Last updated: September 27, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 14, 2008

Last Updated Date

September 27, 2011

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PTSD symptom severity: (a) interviewer rating (PSS-I); (b) self-report (PDS) [ Time Frame: Assessed at post-treatment, 3 months and 12 months follow-up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00716638 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Depressive symptom severity (Beck Depression Inventory, BDI) [ Time Frame: assessed at post-treatment, 3 months and 12 months follow-up ] [ Designated as safety issue: No ]
Severity of anxiety symptoms (Beck Anxiety Inventory, BAI) [ Time Frame: assessed at posttreatment, 3 months and 12 months follow-up ] [ Designated as safety issue: No ]
Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI) [ Time Frame: post-treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trauma-focused CBT Versus EMDR in the Treatment of Posttraumatic Stress Disorder

Official Title ^ICMJE

Trauma-focused CBT vs. EMDR in the Treatment of Posttraumatic Stress Disorder

Brief Summary

This study will evaluate the effectiveness of trauma-focused cognitive behaviour therapy (TF-CBT) versus eye movement desensitization and reprocessing (EMDR) in the treatment of trauma survivors with post-traumatic stress disorder (PTSD). Patients will be randomly assigned to TF-CBT or EMDR. Follow-up assessments will be conducted at 3 and 12 months post-treatment. In addition to comparing the efficacy of the two protocols, an additional focus will lie on identifying predictors for treatment outcome.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Stress Disorders, Post-Traumatic

Intervention ^ICMJE

Behavioral: Trauma-focused Cognitive Behavior Therapy
This intervention comprises 10 sessions of trauma-focused cognitive behavior therapy for PTSD with the components (a) prolonged imaginal exposure, (b) in vivo exposure, and (c) cognitive restructuring.
Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)
This intervention comprises 10 sessions of EMDR according to the standard protocol.

Study Arm (s)

Experimental: Treatment group 1
Trauma-focused Cognitive Behavior Therapy (TF-CBT)

Intervention: Behavioral: Trauma-focused Cognitive Behavior Therapy
Experimental: Treatment group 2
Eye Movement Desensitization and Reprocessing (EMDR)

Intervention: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2014

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

A full diagnosis of PTSD according to the DSM-IV or subthreshold PTSD (criteria for intrusive re-experiencing are fulfilled and either three avoidance/numbing symptoms or two hyperarousal symptoms are present)
PTSD is related to one or more single-event traumas and participants have a clear memory of this event/these events (sufficient for constructing scenes to be used in exposure)
Age between 18 and 70
Sufficient fluency in Dutch to complete treatment and research protocol
If participants are using anti-depressants, they need to be on a stable dose for at least 2 weeks before the beginning of treatment and remain on this dose throughout the treatment.

Exclusion Criteria:

Dementia or other severe cognitive impairment
Psychosis
Depression with suicidal ideation
Bipolar disorder
Borderline Personality Disorder
Anti-social personality disorder
Substance dependence
Current use of tranquilizers
Exposure to prolonged and/or chronic trauma ("type-II-trauma")

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Thomas Ehring, PhD

+31-20-5256858 ext 6858

t.w.a.ehring@uva.nl

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00716638

Other Study ID Numbers ^ICMJE

2008-KP-343

Has Data Monitoring Committee

Responsible Party

Paul M.G.Emmelkamp, VU University of Amsterdam

Study Sponsor ^ICMJE

VU University of Amsterdam

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Paul MG Emmelkamp, Professor	University of Amsterdam, The Netherlands
Study Director:	Thomas Ehring, PhD	University of Amsterdam, The Netherlands

Information Provided By

VU University of Amsterdam

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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