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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Paul M.G.Emmelkamp, VU University of Amsterdam.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716638
First Posted: July 16, 2008
Last Update Posted: November 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paul M.G.Emmelkamp, VU University of Amsterdam
July 14, 2008
July 16, 2008
November 1, 2013
July 2008
July 2014   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00716638 on ClinicalTrials.gov Archive Site
  • Depressive symptom severity (Beck Depression Inventory, BDI) [ Time Frame: assessed at post-treatment, 3 months and 12 months follow-up ]
  • Severity of anxiety symptoms (Beck Anxiety Inventory, BAI) [ Time Frame: assessed at posttreatment, 3 months and 12 months follow-up ]
  • Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI) [ Time Frame: post-treatment ]
Same as current
Not Provided
Not Provided
 
Trauma-focused CBT Versus EMDR in the Treatment of Posttraumatic Stress Disorder
Trauma-focused CBT vs. EMDR in the Treatment of Posttraumatic Stress Disorder
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stress Disorders, Post-Traumatic
  • 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.
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
90
July 2014
July 2014   (Final data collection date for primary outcome measure)

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")
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00716638
2008-KP-343
No
Not Provided
Not Provided
Paul M.G.Emmelkamp, VU University of Amsterdam
VU University of Amsterdam
Not Provided
Principal Investigator: Paul MG Emmelkamp, Professor University of Amsterdam
Study Director: Thomas Ehring, PhD University of Amsterdam
VU University of Amsterdam
October 2013

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