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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Zentrum für Integrative Psychiatrie.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Konstanz
Information provided by:
Zentrum für Integrative Psychiatrie
ClinicalTrials.gov Identifier:
NCT01033708
First received: December 15, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

December 15, 2009
December 15, 2009
October 2009
October 2011   (final data collection date for primary outcome measure)
Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 0 - 1 - 6 - 12 - 24 month ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Borderline symptom checklist 23 (BSL) [ Time Frame: 0 - 1 - 6 - 12 - 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder
A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Posttraumatic Stress Disorders
  • Borderline Personality Disorders
Behavioral: narrative exposure therapy
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
  • Active Comparator: treatment as usual
    Treatment as usual
    Intervention: Behavioral: narrative exposure therapy
  • Experimental: narrative exposure therapy
    Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
    Intervention: Behavioral: narrative exposure therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
October 2013
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
No
Not Provided
Germany
 
NCT01033708
NET
No
Zentrum für Integrative Psychiatrie
Zentrum für Integrative Psychiatrie
University of Konstanz
Not Provided
Zentrum für Integrative Psychiatrie
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP