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

NCT00716638 | Completed

• 1 other identifier: 2008-KP-343
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Assessed at post-treatment, 3 months and 12 months follow-up

Secondary Outcomes (3)

• 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

Study Arms (2)

Treatment group 1

EXPERIMENTAL

Trauma-focused Cognitive Behavior Therapy (TF-CBT)

Behavioral: Trauma-focused Cognitive Behavior Therapy

Treatment group 2

EXPERIMENTAL

Eye Movement Desensitization and Reprocessing (EMDR)

Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)

Interventions

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.

Treatment group 1

Eye Movement Desensitization and Reprocessing (EMDR) BEHAVIORAL

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

Treatment group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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")

Sponsors & Collaborators

• VU University of Amsterdam: lead

Study Sites (1)

PsyQ

Zaandam, 1500 AE, Netherlands

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Paul MG Emmelkamp, Professor

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

• Thomas Ehring, PhD

  University of Amsterdam

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

NL (1)