Posttraumatic Stress DisordersNETNCT01033708
A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder
A study testing narrative exposure therapy in people with Posttraumatic Stress Disorders and Borderline Personality Disorders, run by Zentrum für Integrative Psychiatrie at 1 site in Germany.
Trial summary
Definition of the efficacy of NET compared with "treatment as usual" in the treatment of patients with complex traumatic disease (borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD)) as assessed by structured clinical interviews. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Posttraumatic Stress Disorders, Borderline Personality Disorders
- What is being tested?
- narrative exposure therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Oct 2013
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV -TR Diagnosis axis II: borderline personality disorder; axis I: posttraumatic stress disorder
- stable medication
- age 18-45 years, gender female
- legal competence
- sufficient cognitive function
- sufficient knowledge of the German or English language
Who cannot join
- Known severe internal, neurological, musculoskeletal, endocrinological or sleep disorders with organic origin (clinical examination during the screening visit, judged by the investigator)
- gravidity (positive ß-HCG test)
- continuing and not interruptible exposure to sexual or physical abuse
- acute suicidal tendency
- positive drug-screening in urine toxicology test
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Zentrum Integrative Psychiatrie
Kiel, 24105
Pabst, psychologist, +49 431 9900 2681, a.pabst@zip-kiel.de
Seeck, MD, +49 431 9900 2681, m.seeck-hirschner@zip-kiel.de
About this study
Definition of the efficacy of NET compared with "treatment as usual" in the treatment of patients with complex traumatic disease (borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD)) as assessed by structured clinical interviews. Furthermore, to evaluate the sleep, cortisol level and epigenetic differences in the process of the specific therapy compared to treatment as usual.
Read the detailed description
Experimental intervention:
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity.
Control intervention:
Treatment as usual.
Follow-up per patient:
3 follow-up assessments- 4 weeks, 6 months,12 months and 24 months after end of experimental/ control intervention
Duration of intervention per patient:
Both treatment types will be conducted for 10-14 sessions of 60-90 min in length.
Additionally 5 sleep laboratory investigations (1 pre- and 4 post- intervention (4 weeks, 6 months, 12 months, 24 months after treatment)) will be carried out. Additionally the cortisol level in the hair and epigenetic markers will be recorded. The estimated observation time is 2 years.
- Being tested
- narrative exposure therapy
- Keywords
- Psychotherapy, PTSD, Borderline personality disorders
- Medical subject headings
- Stress Disorders, Post-Traumatic, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
narrative exposure therapyBehavioural
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
| Study group | Role | What they receive |
|---|---|---|
| treatment as usual | Active comparator | Treatment as usual Receives: Behavioral: narrative exposure therapy |
| narrative exposure therapy | Experimental | Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities Receives: Behavioral: narrative exposure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale (CAPS)
Measured: 0 - 1 - 6 - 12 - 24 month
Secondary outcomes (1)
Borderline symptom checklist 23 (BSL)
Measured: 0 - 1 - 6 - 12 - 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2011 (estimated)
- Study completionOct 2013 (estimated)
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 Posttraumatic Stress DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zentrum für Integrative Psychiatrie
- Sponsor type
- University, hospital or other
- Collaborators
- University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033708
- Sponsor's protocol ID
- NET
- Acronym
- NET
- Status last verified
- Oct 2009
- First submitted
- 15 Dec 2009
- Last updated
- 16 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Weinhold SL, Goder R, Pabst A, Scharff AL, Schauer M, Baier PC, Aldenhoff J, Elbert T, Seeck-Hirschner M. Sleep recordings in individuals with borderline personality disorder before and after trauma therapy. J Neural Transm (Vienna). 2017 Feb;124(Suppl 1):99-107. doi: 10.1007/s00702-016-1536-3. Epub 2016 Mar 12.
PubMed 26970970
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT01033708
- Acronym / sponsor ID
- NET / NET
- Keywords
- Psychotherapy, PTSD, Borderline personality disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zentrum für Integrative PsychiatrieUniversity, hospital or other
- Collaborators
- University of Konstanz
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 16 Dec 2009 (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.
Definition of the efficacy of NET compared with "treatment as usual" in the treatment of patients with complex traumatic disease (borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD)) as assessed by structured clinical interviews. Furthermore, to evaluate the sleep, cortisol level and epigenetic differences in the process of the specific therapy compared to treatment as usual.
Detailed description
Experimental intervention:
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity.
Control intervention:
Treatment as usual.
Follow-up per patient:
3 follow-up assessments- 4 weeks, 6 months,12 months and 24 months after end of experimental/ control intervention
Duration of intervention per patient:
Both treatment types will be conducted for 10-14 sessions of 60-90 min in length.
Additionally 5 sleep laboratory investigations (1 pre- and 4 post- intervention (4 weeks, 6 months, 12 months, 24 months after treatment)) will be carried out. Additionally the cortisol level in the hair and epigenetic markers will be recorded. The estimated observation time is 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment as usual | Active comparator | Behavioral: narrative exposure therapyTreatment as usual |
| narrative exposure therapy | Experimental | Behavioral: narrative exposure therapyNarrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- DSM-IV -TR Diagnosis axis II: borderline personality disorder; axis I: posttraumatic stress disorder
- stable medication
- age 18-45 years, gender female
- legal competence
- sufficient cognitive function
Key exclusion criteria (5 listed)
- Known severe internal, neurological, musculoskeletal, endocrinological or sleep disorders with organic origin (clinical examination during the screening visit, judged by the investigator)
- gravidity (positive ß-HCG test)
- continuing and not interruptible exposure to sexual or physical abuse
- acute suicidal tendency
- positive drug-screening in urine toxicology test
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 |
|---|---|---|
| narrative exposure therapyNarrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities | Behavioural | narrative exposure therapy, treatment as usual |
Primary outcome
Clinician-Administered PTSD Scale (CAPS)
Time frame: 0 - 1 - 6 - 12 - 24 month
1 secondary outcome
Borderline symptom checklist 23 (BSL)
Time frame: 0 - 1 - 6 - 12 - 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2009.
- Derived from this study: PubMed 26970970Weinhold SL, Goder R, Pabst A, Scharff AL, Schauer M, Baier PC, Aldenhoff J, Elbert T, Seeck-Hirschner M. Sleep recordings in individuals with borderline personality disorder before and after trauma therapy. J Neural Transm (Vienna). 2017 Feb;124(Suppl 1):99-107. doi: 10.1007/s00702-016-1536-3. Epub 2016 Mar 12.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing narrative exposure therapy in people with Posttraumatic Stress Disorders and Borderline Personality Disorders, run by Zentrum für Integrative Psychiatrie at 1 site in Germany.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Dec 2009. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale (CAPS) (time frame: 0 - 1 - 6 - 12 - 24 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 NCT01033708, 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 16 Dec 2009.