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Efficacy of Transference-Focused Psychotherapy for Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Transference-Focused Psychotherapy
treatment by experienced community psychotherapists
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring borderline personality disorder, randomized controlled trial, Transference-Focused Psychotherapy, treatment by experienced community psychotherapists

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Psychoanalysis and Psychotherapy, Medical University Vienna
  • Dept. of Psychiatry, Technical University of Munich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TFP

ECP

Arm Description

Transference-Focused Psychotherapy

treatment by experienced community psychotherapists

Outcomes

Primary Outcome Measures

Drop-out
Did not finish one year of treatment.
Suicidality (Suicide Attempts)

Secondary Outcome Measures

Psychosocial Functioning (Global Assessment of Functioning, GAF-Score)
Level of Personality Organization (Structured Interview for Personality Organization, STIPO)
Number of Self-harming Acts
Self-assessment of Psychopathology (BDI, STAI, BSI)
Attachment Style and Reflective Function (Adult Attachment Interview, AAI)
Borderline Symptomatology (DSM-IV Criteria)

Full Information

First Posted
July 9, 2008
Last Updated
February 4, 2015
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT00714311
Brief Title
Efficacy of Transference-Focused Psychotherapy for Borderline Personality Disorder
Official Title
A Randomized-Controlled Trial of Transference-Focused Psychotherapy vs. Treatment by Experienced Community Psychotherapists for Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Muenster

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
borderline personality disorder, randomized controlled trial, Transference-Focused Psychotherapy, treatment by experienced community psychotherapists

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TFP
Arm Type
Active Comparator
Arm Description
Transference-Focused Psychotherapy
Arm Title
ECP
Arm Type
Active Comparator
Arm Description
treatment by experienced community psychotherapists
Intervention Type
Behavioral
Intervention Name(s)
Transference-Focused Psychotherapy
Intervention Description
Outpatient psychotherapy according to the treatment manual, sessions of 50 minutes twice per week
Intervention Type
Behavioral
Intervention Name(s)
treatment by experienced community psychotherapists
Intervention Description
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.
Primary Outcome Measure Information:
Title
Drop-out
Description
Did not finish one year of treatment.
Time Frame
1 year
Title
Suicidality (Suicide Attempts)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Psychosocial Functioning (Global Assessment of Functioning, GAF-Score)
Time Frame
1 year
Title
Level of Personality Organization (Structured Interview for Personality Organization, STIPO)
Time Frame
1 year
Title
Number of Self-harming Acts
Time Frame
1 year
Title
Self-assessment of Psychopathology (BDI, STAI, BSI)
Time Frame
1 year
Title
Attachment Style and Reflective Function (Adult Attachment Interview, AAI)
Time Frame
1 year
Title
Borderline Symptomatology (DSM-IV Criteria)
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Doering, MD
Organizational Affiliation
University of Muenster, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Psychoanalysis and Psychotherapy, Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Dept. of Psychiatry, Technical University of Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17541052
Citation
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. doi: 10.1176/ajp.2007.164.6.922.
Results Reference
background
PubMed Identifier
17154733
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):1027-1040. doi: 10.1037/0022-006X.74.6.1027.
Results Reference
background
PubMed Identifier
18558958
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.
Results Reference
background
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
PubMed Identifier
32368793
Citation
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Results Reference
derived
PubMed Identifier
20435966
Citation
Doering S, Horz S, Rentrop M, Fischer-Kern M, Schuster P, Benecke C, Buchheim A, Martius P, Buchheim P. Transference-focused psychotherapy v. treatment by community psychotherapists for borderline personality disorder: randomised controlled trial. Br J Psychiatry. 2010 May;196(5):389-95. doi: 10.1192/bjp.bp.109.070177.
Results Reference
derived

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Efficacy of Transference-Focused Psychotherapy for Borderline Personality Disorder

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