Efficacy of Transference-Focused Psychotherapy for Borderline Personality Disorder

Study Overview
=================
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.

Official Title
-----------------
A Randomized-Controlled Trial of Transference-Focused Psychotherapy vs. Treatment by Experienced Community Psychotherapists for Borderline Personality Disorder

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Behavioral: Transference-Focused Psychotherapy
* Behavioral: treatment by experienced community psychotherapists


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TFP<br>Transference-Focused Psychotherapy | Behavioral: Transference-Focused Psychotherapy<br>* Outpatient psychotherapy according to the treatment manual, sessions of 50 minutes twice per week<br>|
| Active Comparator: ECP<br>treatment by experienced community psychotherapists | Behavioral: treatment by experienced community psychotherapists<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop-out | Did not finish one year of treatment. | 1 year | 
| Suicidality (Suicide Attempts) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial Functioning (Global Assessment of Functioning, GAF-Score) |  | 1 year | 
| Level of Personality Organization (Structured Interview for Personality Organization, STIPO) |  | 1 year | 
| Number of Self-harming Acts |  | 1 year | 
| Self-assessment of Psychopathology (BDI, STAI, BSI) |  | 1 year | 
| Attachment Style and Reflective Function (Adult Attachment Interview, AAI) |  | 1 year | 
| Borderline Symptomatology (DSM-IV Criteria) |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
borderline personality disorder, randomized controlled trial, Transference-Focused Psychotherapy, treatment by experienced community psychotherapists