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

September 11, 2018 updated by: Paul M.G.Emmelkamp, VU University of Amsterdam

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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")

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Assessed at post-treatment, 3 months and 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Depressive symptom severity (Beck Depression Inventory, BDI)
Time Frame: assessed at post-treatment, 3 months and 12 months follow-up
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
assessed at posttreatment, 3 months and 12 months follow-up
Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI)
Time Frame: post-treatment
post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VU University of Amsterdam

Investigators

  • Study Director: Thomas Ehring, PhD, University of Amsterdam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2008

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (ESTIMATE)

July 16, 2008

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-KP-343

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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