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

Posttraumatic Stress Disorders Clinical Trial

— NET  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01033708
• Other study ID #: NET
• Status: Unknown status
• Phase: N/A
• First received: December 15, 2009
• Last updated: December 15, 2009
• Start date: October 2009
• Est. completion date: October 2013

Study information

• Verified date: October 2009
• Source: Zentrum für Integrative Psychiatrie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 80
• Est. completion date: October 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Borderline Personality Disorders
• Disease
• Personality Disorders
• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic

Intervention

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

Locations

Country	Name	City	State
Germany	Zentrum Integrative Psychiatrie	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
Zentrum für Integrative Psychiatrie	University of Konstanz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-Administered PTSD Scale (CAPS)		0 - 1 - 6 - 12 - 24 month
Secondary	Borderline symptom checklist 23 (BSL)		0 - 1 - 6 - 12 - 24