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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00714311
Other study ID # 1106/04
Secondary ID 10636DPG0802
Status Completed
Phase N/A
First received July 9, 2008
Last updated February 4, 2015
Start date October 2004
Est. completion date February 2015

Study information

Verified date February 2015
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find out whether Transference-Focused Psychotherapy (TFP) is effective in the treatment of Borderline Personality Disorder.


Description:

Borderline personality disorder represents a sever clinical condition that affects 1-2% of the community and is characterized by a pervasive instability of interpersonal relationships, self-image, and affects, as well as a marked impulsivity; up to 10% of the patients commit suicide.

Transference-Focused Psychotherapy (TFP) is one psychotherapeutic approach among five that have been manualized and evaluated in RCTs. So far, TFP has not been compared to a control condition which is a crucial step in the evaluation of the efficacy of a psychosocial intervention.

This study is an RCT that compares one year of outpatient TFP to treatment by experienced community psychotherapists for borderline personality disorder.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date February 2015
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Written informed consent to the participation in the study

- Diagnosis of BPD according to DSM-IV as assessed using the SCID-II

- Age between 18 and 45 years

- Sufficient knowledge of the German language

Exclusion Criteria:

- Diagnosis of schizophrenia, bipolar disorder, severe substance abuse, organic pathology, or mental retardation according to DSM-IV as assessed using the SCID-I

- Diagnosis of antisocial personality disorder according to DSM-IV as assessed using the SCID-II

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Transference-Focused Psychotherapy
Outpatient psychotherapy according to the treatment manual, sessions of 50 minutes twice per week
treatment by experienced community psychotherapists
Outpatient psychotherapy in private practices or outpatient units of psychiatric hospitals. Licensed psychotherapists with experience and special interest in the treatment of borderline patients are treating according to the method they have learned.

Locations

Country Name City State
Austria Dept. of Psychoanalysis and Psychotherapy, Medical University Vienna Vienna
Germany Dept. of Psychiatry, Technical University of Munich Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Muenster

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (3)

Clarkin JF, Levy KN, Lenzenweger MF, Kernberg OF. Evaluating three treatments for borderline personality disorder: a multiwave study. Am J Psychiatry. 2007 Jun;164(6):922-8. — View Citation

Kernberg OF, Yeomans FE, Clarkin JF, Levy KN. Transference focused psychotherapy: overview and update. Int J Psychoanal. 2008 Jun;89(3):601-20. doi: 10.1111/j.1745-8315.2008.00046.x. Review. — View Citation

Levy KN, Meehan KB, Kelly KM, Reynoso JS, Weber M, Clarkin JF, Kernberg OF. Change in attachment patterns and reflective function in a randomized control trial of transference-focused psychotherapy for borderline personality disorder. J Consult Clin Psychol. 2006 Dec;74(6):1027-40. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Drop-out Did not finish one year of treatment. 1 year No
Primary Suicidality (Suicide Attempts) 1 year No
Secondary Psychosocial Functioning (Global Assessment of Functioning, GAF-Score) 1 year No
Secondary Level of Personality Organization (Structured Interview for Personality Organization, STIPO) 1 year No
Secondary Number of Self-harming Acts 1 year No
Secondary Self-assessment of Psychopathology (BDI, STAI, BSI) 1 year No
Secondary Attachment Style and Reflective Function (Adult Attachment Interview, AAI) 1 year No
Secondary Borderline Symptomatology (DSM-IV Criteria) 1 month No
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