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OpenTrials
Completed

NCT Number: NCT00716638

Trauma-focused CBT Versus 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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PsyQ

Zaandam, 1500 AE, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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")

Treatment and study plan

Trauma-focused Cognitive Behavior Therapy

Behavioral

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)

Behavioral

This intervention comprises 10 sessions of EMDR according to the standard protocol.

Primary outcomes

  1. 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 outcomes

  1. Depressive symptom severity (Beck Depression Inventory, BDI)

    Time frame: assessed at post-treatment, 3 months and 12 months follow-up

  2. Severity of anxiety symptoms (Beck Anxiety Inventory, BAI)

    Time frame: assessed at posttreatment, 3 months and 12 months follow-up

  3. Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI)

    Time frame: post-treatment

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Jul 16, 2008
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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