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Clinical Trials/NCT02517723
NCT02517723
Completed
Not Applicable

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)

Evangelisches Krankenhaus Bielefeld gGmbH1 site in 1 country67 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Borderline Personality Disorder
Sponsor
Evangelisches Krankenhaus Bielefeld gGmbH
Enrollment
67
Locations
1
Primary Endpoint
Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Narrative Exposure Therapy (NET) is an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity. Patients with Borderline Personality Disorder (BPD) often suffer from a comorbid Posttraumatic Stress Disorder (PTSD) caused by multiple traumatic events. Therapeutic aims are the reduction of PTSD-Symptoms in these patients via activation of associative neural networks related to traumatic experiences and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography. This practice enables the processing of and coping with painful memories and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. The investigators assume that using NET the reduction of PTSD symptom severity is greater compared to treatment by Dialectical-Behavioral Therapy (DBT).

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
January 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Sponsor
Evangelisches Krankenhaus Bielefeld gGmbH
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. med. Martin Driessen

Martin Driessen, Prof. Dr. med.

Evangelisches Krankenhaus Bielefeld gGmbH

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Change from first investigation in Severity of Dissociative Symptoms at 18 months (Fragebogen zu Dissoziativen Symptome ;FDS)(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 Borderline Symptome Severity at 18 months(Borderline Symptom Liste; BSL)(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)(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 Quality of Life at 12 months (WHO-Qualitiy of Life; WHOQOL)(first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4))

Study Sites (1)

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