Clinical trial NCT01033708: A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder
Official title: A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posttraumatic Stress Disorders
Borderline Personality Disorders
Keywords: Psychotherapy
PTSD
Borderline personality disorders
Lead sponsor: Zentrum für Integrative Psychiatrie
Sponsor class: OTHER
Collaborators: name: University of Konstanz
First posted: 2009-12-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: 0 - 1 - 6 - 12 - 24 month
Secondary outcomes:
measure: Borderline symptom checklist 23 (BSL)
timeFrame: 0 - 1 - 6 - 12 - 24
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Zentrum Integrative Psychiatrie
Study officials:
References:
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.