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

NCT ID: NCT00716638

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2015-11-30

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.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group 1

Trauma-focused Cognitive Behavior Therapy (TF-CBT)

Group Type: EXPERIMENTAL

Trauma-focused Cognitive Behavior Therapy

Intervention Type: 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.

Treatment group 2

Eye Movement Desensitization and Reprocessing (EMDR)

Group Type: EXPERIMENTAL

Eye Movement Desensitization and Reprocessing (EMDR)

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eye Movement Desensitization and Reprocessing (EMDR)

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

Intervention Type: BEHAVIORAL

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")

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VU University of Amsterdam

OTHER

Sponsor Role: lead

Responsible Party

Paul M.G.Emmelkamp

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul MG Emmelkamp, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Amsterdam

Thomas Ehring, PhD

Role: STUDY_DIRECTOR

University of Amsterdam

Locations

PsyQ

Zaandam, , Netherlands

Countries

Netherlands

Other Identifiers

2008-KP-343

Identifier Type: -

Identifier Source: org_study_id