Clinical trial NCT00329992: Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
Official title: Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Posttraumatic Stress Disorder
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Herrmann-Klaus-Stiftung, Switzerland
name: Olga Mayenfisch Stiftung, Zurich, Switzerland
name: Jubiläumsspende für die Universität Zürich, Switzerland
First posted: 2006-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores
timeFrame: Last month
Secondary outcomes:
measure: Ability to work and use of health care facilities
timeFrame: Last months
measure: Comorbidity: Structured Clinical Interview for DSM-IV SCID I (First et al. 1996); Hospital Anxiety and Depression Scale HADS (Zigmond and Snaith 1983)
timeFrame: Last month
measure: Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000)
timeFrame: Last month
measure: Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999)
timeFrame: Last month
measure: Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996)
timeFrame: Since trauma
measure: EEG, event-related potentials: P300
timeFrame: At assessment
measure: Post-therapy / post-waitlist comparison, follow-up at 6month post therapy
timeFrame: Last month
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Psychiatric Department, University Hospital
Study officials:
affiliation: University of Zurich
name: Ulrich Schnyder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich
name: Lutz Wittmann, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schnyder U, Muller J, Maercker A, Wittmann L. Brief eclectic psychotherapy for PTSD: a randomized controlled trial. J Clin Psychiatry. 2011 Apr;72(4):564-6. doi: 10.4088/JCP.10l06247blu. No abstract available.