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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Posttraumatic Stress Disorders, Borderline Personality Disorders

Intervention / Treatment
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* Behavioral: narrative exposure therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment as usual<br>Treatment as usual | Behavioral: narrative exposure therapy<br>* Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities<br>|
| Experimental: narrative exposure therapy<br>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<br>* Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-Administered PTSD Scale (CAPS) |  | 0 - 1 - 6 - 12 - 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borderline symptom checklist 23 (BSL) |  | 0 - 1 - 6 - 12 - 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotherapy, PTSD, Borderline personality disorders