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Clinical Trials/NCT01033708
NCT01033708
Unknown
Not Applicable

A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder

Zentrum für Integrative Psychiatrie1 site in 1 country80 target enrollmentOctober 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posttraumatic Stress Disorders
Sponsor
Zentrum für Integrative Psychiatrie
Enrollment
80
Locations
1
Primary Endpoint
Clinician-Administered PTSD Scale (CAPS)
Last Updated
16 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
October 2013
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zentrum für Integrative Psychiatrie

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Clinician-Administered PTSD Scale (CAPS)

Time Frame: 0 - 1 - 6 - 12 - 24 month

Secondary Outcomes

  • Borderline symptom checklist 23 (BSL)(0 - 1 - 6 - 12 - 24)

Study Sites (1)

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