An 18-Month Psychotherapy of Borderline Personality Disorder

NCT ID: NCT03329677

Last Updated: 2024-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2024-02-10

Brief Summary

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The purpose of the study is to examine the impact of an 18-month psychotherapy treatment for borderline personality disorder. The investigators will examine changes in psychosocial and work functioning in patients with borderline personality disorder using an 18-month psychotherapeutic treatment.

The investigators are recruiting female patients between the ages of 18-35 who meet DSM criteria for BPD.

The investigators are excluding patients who meet the following criteria:

* psychotic disorders
* a current major depressive episode
* bipolar I disorder
* current substance dependence
* antisocial personality disorder.
* unable to undergo 18-months of twice weekly psychotherapy in NYC (due to the COVID19 pandemic in person meetings are suspended (see detailed description) but will be restated once this is considered safe again)

Participants in the study will receive 18-months of twice weekly psychotherapy, free of charge, as well as compensation for follow-up assessments. They may be currently taking psychiatric medication.

Participants will be assessed using semi-structured diagnostic interviews, self-report instruments, and computerized tasks in an initial assessment session lasting about 6-8 hours. They will also be assessed using computerized tasks. Follow-up assessments will occur throughout the treatment as well as after the treatment, lasting about 1-4 hours. The investigators will also be collecting information on their treatment history and psychiatric medication as part of the study.

Detailed Description

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Patients with borderline personality disorder (BPD) will be provided with an empirically supported form of psychotherapy for BPD patients called transference-focused psychotherapy (TFP) and medication treatment, if indicated. The primary goal of the current study is to detect changes in psychological, psychosocial and work functioning over the course of 18-months of TFP. Previous research has shown that TFP is an effective treatment for BPD over the course of one year, significantly reducing symptoms. An 18-month treatment period will most likely allow patients to achieve significant and lasting gains in work and psychosocial functioning. Each patient will be assessed prior to (baseline), at 3-month intervals throughout, and at the termination of the 18-month treatment period for symptoms, vocational status, and psychosocial functioning. In addition, patients and therapists will complete self-report measures every three months about the therapeutic relationship. After the 18-month treatment period, a final, brief assessment of vocational status, symptoms, and psychosocial functioning will occur.

The therapists doing TFP are professional psychiatrists, psychologists, and social workers who have been trained by Dr. Otto Kernberg in this special form of psychotherapy. In this therapy, the patient and therapist meet for 45-minute sessions two times a week on a weekly basis (except for vacations) for 18 months. Due to the ongoing worldwide pandemic meetings of the therapist and the patient will take place over a secured internet connection for the time being. Once it is considered safe again, the therapy sessions will take place in the therapists' private office

Hypothesis: It is hypothesized that patients in Transference Focused Psychotherapy (TFP) will manifest differential responses to the treatment, depending upon pre-treatment patient psychological and psychiatric characteristics. The investigators expect that some patients will show significant positive changes in symptoms, work, and social functioning at the end of 18 months, and that these positive changes will manifest in psychological and neuropsychological measures. The investigators will investigate the pre-treatment psychological variables (e.g. trait sociability, constraint, and negative affect) and neuropsychological functioning that will be predictive of patient improvement with treatment at the end of 18 months. By the end of the treatment, the investigators expect some patients to approach normal levels of enjoyment and enrichment of their experiences in work and social functioning. As all analyses will occur at the end of the study, response to TFP will not be assessed during the course of treatment. Therefore, patients will not be moved to a different intervention during the course of the study.

Research Question: The investigators have found in our pilot work that symptom change occurs in the first 12 months of TFP followed by substantial work and psychosocial changes in subsequent months. The primary goal of the current pilot project is to demonstrate that TFP over an 18-month treatment period is associated with significant improvement in work and intimate relations, reflecting significant personality changes that should enhance patients' overall effectiveness and gratification in their lives.

Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Our study is a longitudinal (i.e., 18-month) treatment outcome study using a within-subjects design with repeated measures. We do not include a control group or a TAU group in our study design.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Not applicable. Treatment is transference-focused psychotherapy for borderline personality disorder and each participant understands that she will receive it for 18 months.

Study Groups

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Transference-focused Psychotherapy (TFP)

Transference-focused psychotherapy is a psychodynamic talk therapy utilized in treating borderline personality disorder in men and women.

Group Type EXPERIMENTAL

Transference-focused Psychotherapy (TFP)

Intervention Type OTHER

Participants receive 18 months of bi-weekly TFP. Each sessions lasts 45 minutes. During sessions, a therapist employs assorted psychodynamic techniques tailored specially for symptoms and relational difficulties associated with BPD. A participant processes interpersonal experiences with her therapist in sessions alongside her therapist and gains therapeutic insight into her problematic ways of relating to her self and others.

Interventions

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Transference-focused Psychotherapy (TFP)

Participants receive 18 months of bi-weekly TFP. Each sessions lasts 45 minutes. During sessions, a therapist employs assorted psychodynamic techniques tailored specially for symptoms and relational difficulties associated with BPD. A participant processes interpersonal experiences with her therapist in sessions alongside her therapist and gains therapeutic insight into her problematic ways of relating to her self and others.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* We are recruiting female patients between the ages of 18-35 who meet DSM criteria for BPD.

Exclusion Criteria

* We are excluding patients who meet the following criteria:

* psychotic disorders
* a current major depressive episode
* bipolar I disorder
* current substance dependence
* antisocial personality disorder.
* unable to undergo 18-months of twice weekly psychotherapy in NYC
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis S Lee, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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NewYork-Presbyterian/Weill Cornell Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1412015726

Identifier Type: -

Identifier Source: org_study_id

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