Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial - Full Text View

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
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00329992

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 III

MedlinePlus related topics: Post-Traumatic Stress Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

Further study details as provided by University of Zurich:

Primary Outcome Measures:

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 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 ]

Estimated Enrollment:	40
Study Start Date:	April 2004
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment group: Experimental 16 sessions Brief Eclectic Psychotherapy	Behavioral: Brief Eclectic Psychotherapy for PTSD 16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD
Control group: Placebo Comparator Minimal attention waitlist group	Behavioral: Brief Eclectic Psychotherapy for PTSD 16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD

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

Contacts

Contact: Lutz Wittmann, MA

0041 (0)44 255 34 09

lutz.wittmann@usz.ch

Locations

Switzerland
Psychiatric Department, University Hospital	Recruiting
Zurich, Switzerland, 8091
Principal Investigator: Ulrich Schnyder, MD

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

Responsible Party:	University Hospital Zurich, Switzerland ( Prof. Ulrich Schnyder, MD )
Study ID Numbers:	3200BO-102204
Study First Received:	May 23, 2006
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00329992 History of Changes
Health Authority:	Switzerland: Swissmedic

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on May 07, 2009