- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00329992
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
Status
Completed
Conditions
Intervention / Treatment
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
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-
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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:
|
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PLACEBO_COMPARATOR: Control group
Minimal attention waitlist group
|
16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD
Other Names:
|
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
|
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EEG, event-related potentials: P300
Time Frame: At assessment
|
At assessment
|
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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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3200BO-102204
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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