Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

Chronic Posttraumatic Stress Disorder Clinical Trial

Official title:

Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329992
• Other study ID #: 3200BO-102204
• Status: Completed
• Phase: Phase 3
• First received: May 23, 2006
• Last updated: January 19, 2010
• Start date: April 2004
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
Switzerland	Psychiatric Department, University Hospital	Zurich

Sponsors (5)

Lead Sponsor	Collaborator
University of Zurich	Herrmann-Klaus-Stiftung, Switzerland, Jubiläumsspende für die Universität Zürich, Switzerland, Olga Mayenfisch Stiftung, Zurich, Switzerland, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores		Last month	No
Secondary	Ability to work and use of health care facilities		Last months	No
Secondary	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	No
Secondary	Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000)		Last month	No
Secondary	Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999)		Last month	No
Secondary	Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996)		Since trauma	No
Secondary	EEG, event-related potentials: P300		At assessment	No
Secondary	Post-therapy / post-waitlist comparison, follow-up at 6month post therapy		Last month	No