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:
VU University of Amsterdam
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
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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: | September 27, 2011 |
| 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 May 16, 2013