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

This study is currently recruiting participants.
Verified October 2009 by Zentrum für Integrative Psychiatrie
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
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorders
Borderline Personality Disorders
 Behavioral: narrative exposure therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zentrum für Integrative Psychiatrie:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 0 - 1 - 6 - 12 - 24 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Borderline symptom checklist 23 (BSL) [ Time Frame: 0 - 1 - 6 - 12 - 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: treatment as usual
Treatment as usual
 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
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
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033708

Locations
Germany
Zentrum Integrative Psychiatrie Recruiting
Kiel, Germany, 24105
Contact: Pabst, psychologist     +49 431 9900 2681     a.pabst@zip-kiel.de    
Contact: Seeck, MD     +49 431 9900 2681     m.seeck-hirschner@zip-kiel.de    
Principal Investigator: Aldenhoff, MD            
Sponsors and Collaborators
Zentrum für Integrative Psychiatrie
University of Konstanz
  More Information

No publications provided

Responsible Party: Zentrum für Integrative Psychiatrie
ClinicalTrials.gov Identifier: NCT01033708     History of Changes
Other Study ID Numbers: NET
Study First Received: December 15, 2009
Last Updated: December 15, 2009
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Zentrum für Integrative Psychiatrie:
Psychotherapy
PTSD
Borderline personality disorders

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Stress Disorders, Post-Traumatic
 Stress Disorders, Traumatic
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on May 19, 2013