ClinicalTrials.gg
CompletedNCT03329677Updated Feb 16, 2024

An 18-Month Psychotherapy of Borderline Personality Disorder

An interventional study of Transference-focused Psychotherapy (TFP) in Borderline Personality Disorder, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-02-16.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jan 2016, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 81 studies in Borderline Personality Disorder with a site in United States — 15 open to participants now, 17 under way, none of them phase 3. Borderline Personality Disorder · United States.

Enrollment
33rd of 71
61 · median 56
Started
2016
with 1 other
No phase
39 of 81
9 open now
Registered
41st of 81
by date

Among the 81 studies in Borderline Personality Disorder with a site in United States, this one is the 33rd largest by enrollment of the 71 interventional ones that give a count, is one of 2 that started in 2016, is one of 39 with no phase, and was the 41st registered.

Borderline Personality Disorder

278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.

Browse Borderline Personality Disorder studies →

Open to participants now

15 of the 81 studies in Borderline Personality Disorder with a site in United States are open now. Recruiting first, the newest first:

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All 15 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 49 Borderline Personality Disorder studies recruiting now, 18 (37%) set no upper age limit and 30 (61%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 35 Years · female · no healthy volunteers.

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02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Borderline Personality Disorder
04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Transference-focused Psychotherapy (TFP)

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

    Other: Transference-focused Psychotherapy (TFP)

Interventions

  • OtherTransference-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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Every 3 months for 18-month duration of treatment

  2. 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.

    Time frame: Every 3 months for 18-month duration of treatment

  3. 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.

    Time frame: Every 3 months for 18-month duration of treatment

Secondary outcomes

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

    The ALS is a 54-item self-report instrument where subjects rate the tendency of their mood to shift between normal to affectively charged domains of anger, depression, elation and anxiety, as well as their tendency to shift between depression and elation and between depression and anxiety. This measure has good reliability and validity.

    Time frame: Every 3 months for 18-month duration of treatment

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

    The STAXI-2 is a 57-item self-report inventory, which measures the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). The STAXI-2 has good reliability and validity.

    Time frame: Every 3 months for 18-month duration of treatment

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

    The RFQ is a 54-item measure designed to assess the patient's reflective functioning. It is filled out by the client and assesses the client's ability to mentalize and take the perspective of another person. It has good reliability and validity and has been used to assess the reflective function abilities of patients with BPD in previous studies.

    Time frame: Every 3 months for 18-month duration of treatment

07

Study locations

1 site
  • NewYork-Presbyterian/Weill Cornell Medical Center
    New York, New York 10065, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2016 to primary completion in Jan 2024, 96 months.

Of 105 non-industry interventional studies with no phase under Borderline Personality Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's 96 months is above that.

Counting every sponsor, half of 107 studies reached it within 35 months; a quarter within 24 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2017
First posted
Nov 6, 2017
StartActual
Jan 1, 2016
Primary completionActual
Jan 4, 2024
CompletionActual
Feb 10, 2024
Last update
Feb 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03329677
Responsible party
Sponsor
First posted
Nov 6, 2017
Start date
Jan 1, 2016
Primary completion
Jan 4, 2024
Completion
Feb 10, 2024
Last update
Feb 16, 2024

Study contacts

Francis S Lee, M.D., PhD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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