A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder
NET
1 other identifier
interventional
80
1 country
1
Brief 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. Furthermore, to evaluate the sleep, cortisol level and epigenetic differences in the process of the specific therapy compared to treatment as usual.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 15, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedDecember 16, 2009
October 1, 2009
2 years
December 15, 2009
December 15, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinician-Administered PTSD Scale (CAPS)
0 - 1 - 6 - 12 - 24 month
Secondary Outcomes (1)
Borderline symptom checklist 23 (BSL)
0 - 1 - 6 - 12 - 24
Study Arms (2)
treatment as usual
ACTIVE COMPARATORTreatment as usual
narrative exposure therapy
EXPERIMENTALNarrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
Interventions
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zentrum für Integrative Psychiatrielead
- University of Konstanzcollaborator
Study Sites (1)
Zentrum Integrative Psychiatrie
Kiel, 24105, Germany
Related Publications (1)
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.
PMID: 26970970DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 15, 2009
First Posted
December 16, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2013
Last Updated
December 16, 2009
Record last verified: 2009-10