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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 28, 2014