| May 23, 2006 |
| June 2, 2009 |
| April 2004 |
| May 2009 (final data collection date for primary outcome measure) |
| PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores [ Time Frame: Last month ] [ Designated as safety issue: No ] |
- PTSD symptom severity (CAPS, Blake et al. 1998)
- Post-therapy / post-waitlist comparison, controlled for baseline scores, follow-up at 6month post therapy
|
| Complete list of historical versions of study NCT00329992 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Ability to work and use of health care facilities
- Comorbidity: Structured Clinical Interview for DSM-IV SCID I (First et al. 1996); Hospital Anxiety and Depression Scale HADS (Zigmond and Snaith 1983)
- Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000)
- Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999)
- Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996)
- EEG, event-related potentials: P300
- Post-therapy / post-waitlist comparison, follow-up at 6month post therapy
|
| |
| Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial |
| 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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Chronic Posttraumatic Stress Disorder |
| Behavioral: Brief Eclectic Psychotherapy for PTSD |
- Experimental: 16 sessions Brief Eclectic Psychotherapy
- Placebo Comparator: Minimal attention waitlist group
|
| |
| |
| Recruiting |
| 40 |
| December 2009 |
| May 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 70 Years |
| No |
|
|
| Switzerland |
| |
| NCT00329992 |
| Prof. Ulrich Schnyder, MD, University Hospital Zurich, Switzerland |
| 3200BO-102204 |
| University of Zurich |
- Swiss National Science Foundation
- Herrmann-Klaus-Stiftung, Switzerland
- Olga Mayenfisch Stiftung, Zurich, Switzerland
- Jubiläumsspende für die Universität Zürich, Switzerland
|
| Principal Investigator: |
Ulrich Schnyder, MD |
University of Zurich |
|
| Principal Investigator: |
Lutz Wittmann, MA |
University of Zurich |
|
|
| University of Zurich |
| June 2009 |