- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517723
Narrative Exposure Therapy in Women With Borderline Personality Disorder and Posttraumatic Stress Disorder
A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus Dialectical-Behavioral Therapy in Reducing Trauma Related Symptoms in Women Suffering From Borderline Personality Disorder (BPD) and Posttraumatic Stress Disorder (PTSD)
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bielefeld, Germany, 33617
- Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age ≥ 18 years
- DSM-IV-TR diagnoses of BPD and PTSD
- legal competence
- none or stable medication
- illegal drug abstinence for at least the last 6 months
- capacity to consent and contract
Exclusion Criteria:
- other severe mental disorders (e.g., bipolar disorder, acute psychosis)
- simultaneous consumption of drugs
- simultaneous participation in other treatment-studies
- pregnancy or breastfeeding
- lack of capability to negotiate a no-suicide agreement
- suicide attempt or attempts during the 8 weeks prior to start of treatment
- perpetrator-contact
- Body Mass Index (BMI) < 16
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SIC + NET
Waiting List + Standard Inpatient Care + Narrative Exposure Therapy
|
Narrative Exposure Therapy (NET) is based on Testimony Therapy in combination with cognitive behavioural exposure techniques and elements of client-centered counselling. The clients can restore their autobiographic memories about their traumatic experiences. In this way fragmentary memories are transformed into a coherent narrative structure. This practice enables the processing of painful emotions and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. Therapeutic aims are the reduction of PTSD-Symptomload via activation of fear-network and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography. NET will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.
Other Names:
Unspecific group therapy that is identical in both groups (music therapy etc.)
Other Names:
Treatment as usual in the community (no DBT, no exposure of trauma memories)
|
Active Comparator: SIC + DBT
Waiting List + Standard Inpatient Care + Dialectical Behavior Therapy
|
Unspecific group therapy that is identical in both groups (music therapy etc.)
Other Names:
Treatment as usual in the community (no DBT, no exposure of trauma memories)
Dialectical behavior therapy is a cognitive behavioral treatment program developed by Marsha Linehan to treat suicidal clients meeting criteria for BPD. It directly targets suicidal behavior, behaviors that interfere with treatment delivery, and other dangerous, severe, or destabilizing behaviors. Via standard DBT patients improve behavioral capabilities, motivation for skillful behavior, generalization of gains to the natural environment, structuring the treatment environment so that it reinforces functional rather than dysfunctional behaviors. It also targets the therapist capabilities and motivation to treat patients effectively. Patients get weekly individual psychotherapy (1 h/wk), group skills training (3.75 h/wk), a weekly therapist consultation team meetings.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS)
Time Frame: first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3)
|
first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from first investigation in Borderline Symptome Severity at 18 months(Borderline Symptom Liste; BSL)
Time Frame: first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
|
first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
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Change from first investigation in Severity of Dissociative Symptoms at 18 months (Fragebogen zu Dissoziativen Symptome ;FDS)
Time Frame: first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
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first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
|
Change from first investigation in Severity of Depressive Symptoms at 18 months (Becks Depressions Inventar II, BDI-II)
Time Frame: first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
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first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
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Change from first investigation in Quality of Life at 12 months (WHO-Qualitiy of Life; WHOQOL)
Time Frame: first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
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first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
|
Collaborators and Investigators
Investigators
- Study Director: Carolin Steuwe, M.Sc., Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
- Principal Investigator: Martin Driessen, Prof. Dr. med., Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
Publications and helpful links
General Publications
- Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
- Steuwe C, Berg M, Beblo T, Driessen M. Narrative Exposure Therapy in Patients With Posttraumatic Stress Disorder and Borderline Personality Disorder in a Naturalistic Residential Setting: A Randomized Controlled Trial. Front Psychiatry. 2021 Nov 26;12:765348. doi: 10.3389/fpsyt.2021.765348. eCollection 2021.
- Steuwe C, Rullkotter N, Ertl V, Berg M, Neuner F, Beblo T, Driessen M. Effectiveness and feasibility of Narrative Exposure Therapy (NET) in patients with borderline personality disorder and posttraumatic stress disorder - a pilot study. BMC Psychiatry. 2016 Jul 20;16:254. doi: 10.1186/s12888-016-0969-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NET_BPS+PTBS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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