Trauma-Focused CBT Versus EMDR in the Treatment of Posttraumatic Stress Disorder - Full Text View

Sponsored by:	VU University of Amsterdam
Information provided by:	VU University of Amsterdam
ClinicalTrials.gov Identifier:	NCT00716638

Purpose

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.

Condition	Intervention	Phase
Stress Disorders, Post-Traumatic	Behavioral: Trauma-focused Cognitive Behavior Therapy Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)	Phase II Phase III

MedlinePlus related topics: Anxiety Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Factorial Assignment
Official Title:	Trauma-Focused CBT vs. EMDR in the Treatment of Posttraumatic Stress Disorder

Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	90
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment group 1: Experimental Trauma-focused Cognitive Behavior Therapy (TF-CBT)	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.
Treatment group 2: Experimental Eye Movement Desensitization and Reprocessing (EMDR)	Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) This intervention comprises 10 sessions of EMDR according to the standard protocol.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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")

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716638

Contacts

Contact: Thomas Ehring, PhD

+31-20-5256858 ext 6858

t.w.a.ehring@uva.nl

Locations

Netherlands
GGZ 'Dijk en Duin'	Recruiting
Zaandam, Netherlands, 1500 AE

Sponsors and Collaborators

VU University of Amsterdam

Investigators

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

More Information

No publications provided

Responsible Party:	Department of Clinical Psychology, University of Amsterdam, The Netherlands ( Professor Paul M.G. Emmelkamp )
Study ID Numbers:	2008-KP-343
Study First Received:	July 14, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00716638 History of Changes
Health Authority:	Netherlands: Independent Ethics Committee

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Wounds and Injuries

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on May 07, 2009