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Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

This study is currently recruiting participants.
Study NCT00329992.   Last updated on June 5, 2008.   Information provided by University of Zurich

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Descriptive Information Fields
Brief Title  Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
Official Title  Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
Brief Summary

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.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  PTSD symptom severity (CAPS, Blake et al. 1998) [ Time Frame: Last month ] [ Designated as safety issue: No ]
Post-therapy / post-waitlist comparison, controlled for baseline scores, follow-up at 6month post therapy [ Time Frame: Last month ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ]
Condition  Chronic Posttraumatic Stress Disorder
Intervention  Behavioral: Brief Eclectic Psychotherapy for PTSD
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  40
Start Date  April 2004
Completion Date December 2008
Eligibility 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
Gender Both
Ages 18 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Lutz Wittmann, MA     0041 (0)44 255 34 09     lutz.wittmann@usz.ch    
Location Countries  Switzerland
Administrative Information Fields
NCT ID  NCT00329992
Organization ID 3200BO-102204
Secondary IDs ††
Study Sponsor  University of Zurich
Collaborators †† 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    
Information Provided By University of Zurich
Verification Date April 2007
First Received Date  May 23, 2006
Last Updated Date June 5, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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