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

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Trauma-focused Cognitive Behavior Therapy
Eye Movement Desensitization and Reprocessing (EMDR)
Sponsored by
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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")

Sites / Locations

  • PsyQ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment group 1

Treatment group 2

Arm Description

Trauma-focused Cognitive Behavior Therapy (TF-CBT)

Eye Movement Desensitization and Reprocessing (EMDR)

Outcomes

Primary Outcome Measures

PTSD symptom severity: (a) interviewer rating (PSS-I); (b) self-report (PDS)

Secondary Outcome Measures

Depressive symptom severity (Beck Depression Inventory, BDI)
Severity of anxiety symptoms (Beck Anxiety Inventory, BAI)
Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI)

Full Information

First Posted
July 14, 2008
Last Updated
September 11, 2018
Sponsor
VU University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT00716638
Brief Title
Trauma-focused CBT Versus EMDR in the Treatment of Posttraumatic Stress Disorder
Official Title
Trauma-focused CBT vs. EMDR in the Treatment of Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 2008 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group 1
Arm Type
Experimental
Arm Description
Trauma-focused Cognitive Behavior Therapy (TF-CBT)
Arm Title
Treatment group 2
Arm Type
Experimental
Arm Description
Eye Movement Desensitization and Reprocessing (EMDR)
Intervention Type
Behavioral
Intervention Name(s)
Trauma-focused Cognitive Behavior Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Eye Movement Desensitization and Reprocessing (EMDR)
Intervention Description
This intervention comprises 10 sessions of EMDR according to the standard protocol.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Depressive symptom severity (Beck Depression Inventory, BDI)
Time Frame
assessed at post-treatment, 3 months and 12 months follow-up
Title
Severity of anxiety symptoms (Beck Anxiety Inventory, BAI)
Time Frame
assessed at posttreatment, 3 months and 12 months follow-up
Title
Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI)
Time Frame
post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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")
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul MG Emmelkamp, Professor
Organizational Affiliation
University of Amsterdam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Ehring, PhD
Organizational Affiliation
University of Amsterdam
Official's Role
Study Director
Facility Information:
Facility Name
PsyQ
City
Zaandam
ZIP/Postal Code
1500 AE
Country
Netherlands

12. IPD Sharing Statement

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

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