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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716638
• Other study ID #: 2008-KP-343
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: November 2015

Study information

• Verified date: September 2018
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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")

Related Conditions & MeSH terms

• Disease
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• Eye Movement Desensitization and Reprocessing (EMDR)
This intervention comprises 10 sessions of EMDR according to the standard protocol.

Locations

Country	Name	City	State
Netherlands	PsyQ	Zaandam

Sponsors (1)

Lead Sponsor	Collaborator
VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptom severity: (a) interviewer rating (PSS-I); (b) self-report (PDS)		Assessed at post-treatment, 3 months and 12 months follow-up
Secondary	Depressive symptom severity (Beck Depression Inventory, BDI)		assessed at post-treatment, 3 months and 12 months follow-up
Secondary	Severity of anxiety symptoms (Beck Anxiety Inventory, BAI)		assessed at posttreatment, 3 months and 12 months follow-up
Secondary	Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI)		post-treatment