Back to resultsBrief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
Primary Purpose
Chronic Posttraumatic Stress Disorder
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Brief Eclectic Psychotherapy for PTSD
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Posttraumatic Stress Disorder
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
Sites / Locations
- Psychiatric Department, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment group
Control group
Arm Description
16 sessions Brief Eclectic Psychotherapy
Minimal attention waitlist group
Outcomes
Primary Outcome Measures
PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00329992
First Posted
May 23, 2006
Last Updated
January 19, 2010
Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation, Herrmann-Klaus-Stiftung, Switzerland, Olga Mayenfisch Stiftung, Zurich, Switzerland, Jubiläumsspende für die Universität Zürich, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00329992
Brief Title
Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
Official Title
Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation, Herrmann-Klaus-Stiftung, Switzerland, Olga Mayenfisch Stiftung, Zurich, Switzerland, Jubiläumsspende für die Universität Zürich, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Posttraumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
16 sessions Brief Eclectic Psychotherapy
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Minimal attention waitlist group
Intervention Type
Behavioral
Intervention Name(s)
Brief Eclectic Psychotherapy for PTSD
Other Intervention Name(s)
BEP
Intervention Description
16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD
Primary Outcome Measure Information:
Title
PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores
Time Frame
Last month
Secondary Outcome Measure Information:
Title
Ability to work and use of health care facilities
Time Frame
Last months
Title
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
Title
Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000)
Time Frame
Last month
Title
Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999)
Time Frame
Last month
Title
Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996)
Time Frame
Since trauma
Title
EEG, event-related potentials: P300
Time Frame
At assessment
Title
Post-therapy / post-waitlist comparison, follow-up at 6month post therapy
Time Frame
Last month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Schnyder, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lutz Wittmann, MA
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Department, University Hospital
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21527127
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.
Results Reference
derived
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Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
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