Chronic Posttraumatic Stress DisorderPhase 3NCT00329992
Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
A Phase 3 study testing Brief Eclectic Psychotherapy for PTSD in people with Chronic Posttraumatic Stress Disorder, run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Posttraumatic Stress Disorder
- What is being tested?
- Brief Eclectic Psychotherapy for PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2004to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatric Department, University Hospital
Zurich, 8091
About this study
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.
- Conditions
- Chronic Posttraumatic Stress Disorder
- Being tested
- Brief Eclectic Psychotherapy for PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Eclectic Psychotherapy for PTSDBehavioural
Also called BEP
16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 16 sessions Brief Eclectic Psychotherapy Receives: Behavioral: Brief Eclectic Psychotherapy for PTSD |
| Control group | Placebo comparator | Minimal attention waitlist group Receives: Behavioral: Brief Eclectic Psychotherapy for PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores
Measured: Last month
Secondary outcomes (7)
Ability to work and use of health care facilities
Measured: 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)
Measured: Last month
Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000)
Measured: Last month
Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999)
Measured: Last month
Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996)
Measured: Since trauma
EEG, event-related potentials: P300
Measured: At assessment
Post-therapy / post-waitlist comparison, follow-up at 6month post therapy
Measured: Last month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startApr 2004
- Primary completionMay 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Herrmann-Klaus-Stiftung, Switzerland, Olga Mayenfisch Stiftung, Zurich, Switzerland, Jubiläumsspende für die Universität Zürich, Switzerland
- Investigators
- Ulrich Schnyder, MD, Principal investigator, University of ZurichLutz Wittmann, MA, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329992
- Sponsor's protocol ID
- 3200BO-102204
- Status last verified
- Jan 2010
- First submitted
- 23 May 2006
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21527127
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00329992
- Acronym / sponsor ID
- 3200BO-102204
- Conditions
- Chronic Posttraumatic Stress Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Herrmann-Klaus-Stiftung, Switzerland, Olga Mayenfisch Stiftung, Zurich, Switzerland, Jubiläumsspende für die Universität Zürich, Switzerland
- Study start
- Apr 2004
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Brief Eclectic Psychotherapy for PTSD16 sessions Brief Eclectic Psychotherapy |
| Control group | Placebo comparator | Behavioral: Brief Eclectic Psychotherapy for PTSDMinimal attention waitlist group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Eclectic Psychotherapy for PTSDAlso: BEP16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD | Behavioural | Control group, Treatment group |
Primary outcome
PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores
Time frame: Last month
7 secondary outcomes
Ability to work and use of health care facilities
Time frame: 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)
Time frame: Last month
Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000)
Time frame: Last month
Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999)
Time frame: Last month
Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996)
Time frame: Since trauma
EEG, event-related potentials: P300
Time frame: At assessment
Post-therapy / post-waitlist comparison, follow-up at 6month post therapy
Time frame: Last month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
- Derived from this study: PubMed 21527127Schnyder 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.
Related trials for Chronic Posttraumatic Stress Disorder
Not yet recruitingPhase 2
Post-traumatic Estradiol Administration and Care Evaluation (PEACE)
Chronic Musculoskeletal Pain, Sexual Assault
RecruitingPhase 1/2
Ketamine Assisted Psychotherapy for Treating Comorbid Chronic Pain and PTSD
Chronic Pain, Posttraumatic Stress Disorder (PTSD)
Recruiting
Comparative Effectiveness of SPARCS and Unified Protocol for Youth With Chronic Medical Conditions and Trauma-Related Distress
Trauma Exposure, Trauma
Recruiting
CIH Stepped Care for Co-occurring Chronic Pain and PTSD
Chronic Pain, Posttraumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Schnyder, MD principal investigator
University of Zurich
Lutz Wittmann, MA principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brief Eclectic Psychotherapy for PTSD in people with Chronic Posttraumatic Stress Disorder, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores (time frame: Last month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00329992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2010; AzTrials last refreshed its copy on 31 Oct 2026.