- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00714311
Efficacy of Transference-Focused Psychotherapy for Borderline Personality Disorder
A Randomized-Controlled Trial of Transference-Focused Psychotherapy vs. Treatment by Experienced Community Psychotherapists for Borderline Personality Disorder
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: TFP
Transference-Focused Psychotherapy
|
Outpatient psychotherapy according to the treatment manual, sessions of 50 minutes twice per week
|
|
ACTIVE_COMPARATOR: ECP
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drop-out
Time Frame: 1 year
|
Did not finish one year of treatment.
|
1 year
|
|
Suicidality (Suicide Attempts)
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Psychosocial Functioning (Global Assessment of Functioning, GAF-Score)
Time Frame: 1 year
|
1 year
|
|
Level of Personality Organization (Structured Interview for Personality Organization, STIPO)
Time Frame: 1 year
|
1 year
|
|
Number of Self-harming Acts
Time Frame: 1 year
|
1 year
|
|
Self-assessment of Psychopathology (BDI, STAI, BSI)
Time Frame: 1 year
|
1 year
|
|
Attachment Style and Reflective Function (Adult Attachment Interview, AAI)
Time Frame: 1 year
|
1 year
|
|
Borderline Symptomatology (DSM-IV Criteria)
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1106/04
- 10636 (Other Identifier: CTEP)
- DPG0802
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