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Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT00329992
Collaborator
Swiss National Science Foundation (Other), Herrmann-Klaus-Stiftung, Switzerland (Other), Olga Mayenfisch Stiftung, Zurich, Switzerland (Other), Jubiläumsspende für die Universität Zürich, Switzerland (Other)
30
Enrollment
1
Location
2
Arms
68
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brief Eclectic Psychotherapy for PTSD
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
Study Start Date :
Apr 1, 2004
Actual Primary Completion Date :
May 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • BEP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores [Last month]

    Secondary Outcome Measures

    1. Ability to work and use of health care facilities [Last months]

    2. Comorbidity: Structured Clinical Interview for DSM-IV SCID I (First et al. 1996); Hospital Anxiety and Depression Scale HADS (Zigmond and Snaith 1983) [Last month]

    3. Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000) [Last month]

    4. Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999) [Last month]

    5. Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996) [Since trauma]

    6. EEG, event-related potentials: P300 [At assessment]

    7. Post-therapy / post-waitlist comparison, follow-up at 6month post therapy [Last month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00329992
    Other Study ID Numbers:
    • 3200BO-102204
    First Posted:
    May 25, 2006
    Last Update Posted:
    Jan 20, 2010
    Last Verified:
    Jan 1, 2010
    Additional relevant MeSH terms:
    Stress Disorders, Post-Traumatic

    Study Results

    No Results Posted as of Jan 20, 2010