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

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.

Study Overview

• Status: Unknown
• Conditions: Posttraumatic Stress Disorders; Borderline Personality Disorders
• Intervention / Treatment: Behavioral: narrative exposure therapy

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24105
    • Recruiting
    • Zentrum Integrative Psychiatrie
    • Contact: Pabst, psychologist; Phone Number: +49 431 9900 2681; Email: a.pabst@zip-kiel.de
    • Contact: Seeck, MD; Phone Number: +49 431 9900 2681; Email: m.seeck-hirschner@zip-kiel.de
    • Principal Investigator: Aldenhoff, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: treatment as usual; Treatment as usual	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
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zentrum für Integrative Psychiatrie
• Collaborators: University of Konstanz

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: December 15, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Estimate): December 16, 2009
• Last Update Submitted That Met QC Criteria: December 15, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: PTSD; Psychotherapy; Borderline personality disorders
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Personality Disorders; Disease; Stress Disorders, Post-Traumatic; Borderline Personality Disorder
• Other Study ID Numbers: NET