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

This study is currently recruiting participants.
Verified October 2013 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: October 31, 2013
Last verified: October 2013
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trauma-focused CBT vs. EMDR in the Treatment of Posttraumatic Stress Disorder

Resource links provided by NLM:


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 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group 1
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.
Experimental: Treatment group 2
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
PsyQ 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: Paul M.G.Emmelkamp, Professor, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT00716638     History of Changes
Other Study ID Numbers: 2008-KP-343
Study First Received: July 14, 2008
Last Updated: October 31, 2013
Health Authority: Netherlands: Independent Ethics Committee

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014