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

Not Applicable

• Conditions: Posttraumatic Stress Disorders; Borderline Personality Disorders
• Interventions: Behavioral: narrative exposure therapy

• Registration Number: NCT01033708
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2009-10
• Study Start: 2009-10
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Last Update Submitted: 2009-12-15
• Study First Posted: 2009-12-16
• Last Update Posted: 2009-12-16
• Primary Completion: 2011-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment as usual	narrative exposure therapy	Treatment as usual
narrative exposure therapy	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

Name	Time	Method
Clinician-Administered PTSD Scale (CAPS)	0 - 1 - 6 - 12 - 24 month

Secondary Outcome Measures

Name	Time	Method
Borderline symptom checklist 23 (BSL)	0 - 1 - 6 - 12 - 24

Trial Locations

Locations (1)

Zentrum Integrative Psychiatrie; 🇩🇪 Kiel, Germany