An 18-Month Psychotherapy of Borderline Personality Disorder

NCT03329677 | Completed

• 1 other identifier: 1412015726
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (3)

• Social Adjustment Scale (SAS; Weissman, 1971)

  The SAS is a semi-structured interview continuing 42 questions covering an individual's social adjustment and social role within society. This interview has demonstrated good reliability and validity as shown by previous research.

  Every 3 months for 18-month duration of treatment

• Brief Symptom Inventory (BSI; Derogatis, 1993)

  The BSI is a 53-item self-report scale designed to assess psychological symptoms in clinical and non-clinical individuals. The items are rated on a 5-point scale of distress (0-4, ranging from 'not at all' to 'extremely') and reflect 9 symptom dimensions (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism). The BSI also includes a global index of distress (the General Severity Index, GSI) that reflects the mean of all items. The BSI exhibits excellent reliability and validity.

  Every 3 months for 18-month duration of treatment

• Overt Aggression Scale (OAS-M; Coccaro et al., 1991)

  The OAS-M is a clinician-rated scale that characterizes aggressive behavior within the past week based on observation and self-report.

  Every 3 months for 18-month duration of treatment

Secondary Outcomes (3)

• Affective Lability Scale (ALS; Harvey et al., 1989)

  Every 3 months for 18-month duration of treatment

• State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999)

  Every 3 months for 18-month duration of treatment

• Reflective Function Questionnaire (RFQ; Fonagy & Luyten, 2009)

  Every 3 months for 18-month duration of treatment

Study Arms (1)

Transference-focused Psychotherapy (TFP)

EXPERIMENTAL

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

Other: Transference-focused Psychotherapy (TFP)

Interventions

Transference-focused Psychotherapy (TFP) 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.

Transference-focused Psychotherapy (TFP)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

NewYork-Presbyterian/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Francis S Lee, M.D., PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Not applicable. Treatment is transference-focused psychotherapy for borderline personality disorder and each participant understands that she will receive it for 18 months.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: January 1, 2016
• Primary Completion: January 4, 2024
• Study Completion: February 10, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)