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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Behavioral: Trauma-focused Cognitive Behavior Therapy
* Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group 1<br>Trauma-focused Cognitive Behavior Therapy (TF-CBT) | Behavioral: Trauma-focused Cognitive Behavior Therapy<br>* 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.<br>|
| Experimental: Treatment group 2<br>Eye Movement Desensitization and Reprocessing (EMDR) | Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)<br>* This intervention comprises 10 sessions of EMDR according to the standard protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptom severity: (a) interviewer rating (PSS-I); (b) self-report (PDS) |  | Assessed at post-treatment, 3 months and 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptom severity (Beck Depression Inventory, BDI) |  | assessed at post-treatment, 3 months and 12 months follow-up | 
| Severity of anxiety symptoms (Beck Anxiety Inventory, BAI) |  | assessed at posttreatment, 3 months and 12 months follow-up | 
| Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI) |  | post-treatment |