Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03329677 |
| Other study ID # |
1412015726 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2016 |
| Est. completion date |
February 10, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Weill Medical College of Cornell University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
