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Completed

NCT Number: NCT00329992

Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

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.

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Key information

Conditions

Chronic Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Psychiatric Department, University Hospital

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Eclectic Psychotherapy for PTSD

Behavioral

16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD

Other names: BEP

Primary outcomes

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

    Time frame: Last month

Secondary outcomes

  1. Ability to work and use of health care facilities

    Time frame: 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)

    Time frame: Last month

  3. Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000)

    Time frame: Last month

  4. Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999)

    Time frame: Last month

  5. Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996)

    Time frame: Since trauma

  6. EEG, event-related potentials: P300

    Time frame: At assessment

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

    Time frame: Last month

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Herrmann-Klaus-Stiftung, Switzerland
  • Jubiläumsspende für die Universität Zürich, Switzerland
  • Olga Mayenfisch Stiftung, Zurich, Switzerland
  • Swiss National Science Foundation

Registry information

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
May 25, 2006
Registry last updated
Jan 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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