NCT00329992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

Enrollment Period

5.1 years

First QC Date

May 23, 2006

Last Update Submit

January 19, 2010

Conditions

Chronic Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

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

    Last month

Secondary Outcomes (7)

  • Ability to work and use of health care facilities

    Last months

  • 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

  • Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000)

    Last month

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

    Last month

  • Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996)

    Since trauma

  • +2 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

16 sessions Brief Eclectic Psychotherapy

Behavioral: Brief Eclectic Psychotherapy for PTSD

Control group

PLACEBO COMPARATOR

Minimal attention waitlist group

Behavioral: Brief Eclectic Psychotherapy for PTSD

Interventions

Brief Eclectic Psychotherapy for PTSDBEHAVIORAL

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

Also known as: BEP
Control groupTreatment group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Department, University Hospital

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 21527127DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Ulrich Schnyder, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

  • Lutz Wittmann, MA

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 23, 2006

First Posted

May 25, 2006

Study Start

April 1, 2004

Primary Completion

May 1, 2009

Study Completion

December 1, 2009

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

CH(1)