Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

January 19, 2010 updated by: University of Zurich
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zurich, Switzerland, 8091
        • Psychiatric Department, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment group
16 sessions Brief Eclectic Psychotherapy
16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD
Other Names:
  • BEP
PLACEBO_COMPARATOR: Control group
Minimal attention waitlist group
16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD
Other Names:
  • BEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores
Time Frame: Last month
Last month

Secondary Outcome Measures

Outcome Measure
Time Frame
Ability to work and use of health care facilities
Time Frame: Last months
Last months
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
Last month
Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000)
Time Frame: Last month
Last month
Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999)
Time Frame: Last month
Last month
Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996)
Time Frame: Since trauma
Since trauma
EEG, event-related potentials: P300
Time Frame: At assessment
At assessment
Post-therapy / post-waitlist comparison, follow-up at 6month post therapy
Time Frame: Last month
Last month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ulrich Schnyder, MD, University of Zurich
  • Principal Investigator: Lutz Wittmann, MA, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

May 23, 2006

First Submitted That Met QC Criteria

May 23, 2006

First Posted (ESTIMATE)

May 25, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 19, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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