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

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ClinicalTrials.gov Identifier: NCT01033708
Recruitment Status : Unknown
Verified October 2009 by Zentrum für Integrative Psychiatrie.
Recruitment status was:  Recruiting
First Posted : December 16, 2009
Last Update Posted : December 16, 2009
Sponsor:
Collaborator:
University of Konstanz
Information provided by:
Zentrum für Integrative Psychiatrie

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.

Condition or disease Intervention/treatment
Posttraumatic Stress Disorders Borderline Personality Disorders Behavioral: narrative exposure therapy

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : October 2009
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 0 - 1 - 6 - 12 - 24 month ]

Secondary Outcome Measures :
  1. Borderline symptom checklist 23 (BSL) [ Time Frame: 0 - 1 - 6 - 12 - 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Zentrum für Integrative Psychiatrie
ClinicalTrials.gov Identifier: NCT01033708     History of Changes
Other Study ID Numbers: NET
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: December 16, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders