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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01033708
Other study ID # NET
Secondary ID
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
Health authority
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

Study Design


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
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