A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder (NET)
Primary Purpose
Posttraumatic Stress Disorders, Borderline Personality Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
narrative exposure therapy
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorders focused on measuring Psychotherapy, PTSD, Borderline personality disorders
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
Sites / Locations
- Zentrum Integrative PsychiatrieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
treatment as usual
narrative exposure therapy
Arm Description
Treatment as usual
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
Outcomes
Primary Outcome Measures
Clinician-Administered PTSD Scale (CAPS)
Secondary Outcome Measures
Borderline symptom checklist 23 (BSL)
Full Information
NCT ID
NCT01033708
First Posted
December 15, 2009
Last Updated
December 15, 2009
Sponsor
Zentrum für Integrative Psychiatrie
Collaborators
University of Konstanz
1. Study Identification
Unique Protocol Identification Number
NCT01033708
Brief Title
A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder
Acronym
NET
Official Title
A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Zentrum für Integrative Psychiatrie
Collaborators
University of Konstanz
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorders, Borderline Personality Disorders
Keywords
Psychotherapy, PTSD, Borderline personality disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as usual
Arm Title
narrative exposure therapy
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
narrative exposure therapy
Intervention Description
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 Measure Information:
Title
Clinician-Administered PTSD Scale (CAPS)
Time Frame
0 - 1 - 6 - 12 - 24 month
Secondary Outcome Measure Information:
Title
Borderline symptom checklist 23 (BSL)
Time Frame
0 - 1 - 6 - 12 - 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Zentrum Integrative Psychiatrie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pabst, psychologist
Phone
+49 431 9900 2681
Email
a.pabst@zip-kiel.de
First Name & Middle Initial & Last Name & Degree
Seeck, MD
Phone
+49 431 9900 2681
Email
m.seeck-hirschner@zip-kiel.de
First Name & Middle Initial & Last Name & Degree
Aldenhoff, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
26970970
Citation
Weinhold SL, Goder R, Pabst A, Scharff AL, Schauer M, Baier PC, Aldenhoff J, Elbert T, Seeck-Hirschner M. Sleep recordings in individuals with borderline personality disorder before and after trauma therapy. J Neural Transm (Vienna). 2017 Feb;124(Suppl 1):99-107. doi: 10.1007/s00702-016-1536-3. Epub 2016 Mar 12.
Results Reference
derived
Learn more about this trial
A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder
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