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Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

This study has been completed.
Sponsor:
Collaborators:
Swiss National Science Foundation
Herrmann-Klaus-Stiftung, Switzerland
Olga Mayenfisch Stiftung, Zurich, Switzerland
Jubiläumsspende für die Universität Zürich, Switzerland
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00329992
First received: May 23, 2006
Last updated: January 19, 2010
Last verified: January 2010
History of Changes
  Purpose

Participants are randomly assigned to either 16 sessions of Brief Eclectic Psychotherapy (Gersons et al. (2000) Journal Trauma Stress 13: 333-348), comprising psychoeducation, exposure, mementos and writing assignments, domain of meaning and integration, farewell ritual, or a minimal attention control group that will be offered 16 sessions of BEP after a waiting time of four months. Participants in the minimal attention control group receive monthly telephone calls and complete a symptom self monitoring diary (Tarrier, N. et al. (1999) Behavior Therapy 30: 597-605) for three weeks.


Condition Intervention Phase
Chronic Posttraumatic Stress Disorder
 Behavioral: Brief Eclectic Psychotherapy for PTSD
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores [ Time Frame: Last month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ability to work and use of health care facilities [ Time Frame: Last months ] [ Designated as safety issue: No ]
  • Comorbidity: Structured Clinical Interview for DSM-IV SCID I (First et al. 1996); Hospital Anxiety and Depression Scale HADS (Zigmond and Snaith 1983) [ Time Frame: Last month ] [ Designated as safety issue: No ]
  • Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000) [ Time Frame: Last month ] [ Designated as safety issue: No ]
  • Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999) [ Time Frame: Last month ] [ Designated as safety issue: No ]
  • Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996) [ Time Frame: Since trauma ] [ Designated as safety issue: No ]
  • EEG, event-related potentials: P300 [ Time Frame: At assessment ] [ Designated as safety issue: No ]
  • Post-therapy / post-waitlist comparison, follow-up at 6month post therapy [ Time Frame: Last month ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2004
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group
16 sessions Brief Eclectic Psychotherapy
 Behavioral: Brief Eclectic Psychotherapy for PTSD
16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD
Other Name: BEP
Placebo Comparator: Control group
Minimal attention waitlist group
 Behavioral: Brief Eclectic Psychotherapy for PTSD
16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD
Other Name: BEP

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clear memory of an "index" traumatic event (sufficient for constructing a scene to be used in exposure) that occurred no less than six months prior to entering the trial (Montgomery and Bech 2000)
  • PTSD according to the DSM-IV, related to the index traumatic event, as measured with the CAPS: frequency ≥ 1 and intensity ≥ 2 for a symptom to be counted plus a minimum level of overall severity ≥ 50
  • Not receiving other psychotherapy for PTSD during the 16 weeks of active treatment; psychotherapy for other problems, brief check-ins with an existing therapist, and attendance at self-help groups will be allowed
  • If on psychoactive medication: on a stable medication regimen for a minimum of two months prior to entering the trial
  • Aged between 18 and 70 years
  • Sufficient proficiency in the German language to participate in BEP
  • Consent to be randomized into the trial

Exclusion Criteria:

  • Current psychotic, bipolar, substance-related, or severe personality disorder
  • Current severe depressive disorder
  • Severe cognitive impairment or a history of organic mental disorder
  • Evidence of PTSD or depression immediately prior to the index trauma
  • Ongoing threat of traumatic exposure
  • Prominent current suicidal or homicidal ideation
  • Asylum seeking status
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329992

Locations
Switzerland
Psychiatric Department, University Hospital
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
Herrmann-Klaus-Stiftung, Switzerland
Olga Mayenfisch Stiftung, Zurich, Switzerland
Jubiläumsspende für die Universität Zürich, Switzerland
Investigators
Principal Investigator: Ulrich Schnyder, MD University of Zurich
Principal Investigator: Lutz Wittmann, MA University of Zurich
  More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Ulrich Schnyder, MD, University Hospital Zurich, Switzerland
ClinicalTrials.gov Identifier: NCT00329992     History of Changes
Other Study ID Numbers: 3200BO-102204
Study First Received: May 23, 2006
Last Updated: January 19, 2010
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013