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

NCT ID: NCT01033708

Last Updated: 2009-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-10-31

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.

Conditions

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Posttraumatic Stress Disorders Borderline Personality Disorders

Keywords

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Psychotherapy PTSD Borderline personality disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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treatment as usual

Treatment as usual

Group Type ACTIVE_COMPARATOR

narrative exposure therapy

Intervention Type BEHAVIORAL

Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities

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

Group Type EXPERIMENTAL

narrative exposure therapy

Intervention Type BEHAVIORAL

Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities

Interventions

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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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Konstanz

OTHER

Sponsor Role collaborator

Zentrum für Integrative Psychiatrie

OTHER

Sponsor Role lead

Responsible Party

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Zentrum für Integrative Psychiatrie

Locations

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Zentrum Integrative Psychiatrie

Kiel, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Pabst, psychologist

Role: primary

Seeck, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 26970970 (View on PubMed)

Other Identifiers

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NET

Identifier Type: -

Identifier Source: org_study_id