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

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ClinicalTrials.gov Identifier: NCT00716638
Recruitment Status : Unknown
Verified October 2013 by Paul M.G.Emmelkamp, VU University of Amsterdam.
Recruitment status was:  Recruiting
First Posted : July 16, 2008
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
Paul M.G.Emmelkamp, VU University of Amsterdam

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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trauma-focused CBT vs. EMDR in the Treatment of Posttraumatic Stress Disorder
Study Start Date : July 2008
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Depressive symptom severity (Beck Depression Inventory, BDI) [ Time Frame: assessed at post-treatment, 3 months and 12 months follow-up ]
  2. Severity of anxiety symptoms (Beck Anxiety Inventory, BAI) [ Time Frame: assessed at posttreatment, 3 months and 12 months follow-up ]
  3. Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI) [ Time Frame: post-treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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")

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Study Director: Thomas Ehring, PhD University of Amsterdam

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
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders