Borderline Personality DisorderNCT03329677
An 18-Month Psychotherapy of Borderline Personality Disorder
A study testing Transference-focused Psychotherapy (TFP) in people with Borderline Personality Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Transference-focused Psychotherapy (TFP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 10 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- We are recruiting female patients between the ages of 18-35 who meet DSM criteria for BPD.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
About this study
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.
Read more
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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Transference-focused Psychotherapy (TFP)
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Transference-focused Psychotherapy (TFP) | Experimental | Transference-focused psychotherapy is a psychodynamic talk therapy utilized in treating borderline personality disorder in men and women. Receives: Other: Transference-focused Psychotherapy (TFP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Every 3 months for 18-month duration of treatment
Secondary outcomes (3)
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.
Measured: Every 3 months for 18-month duration of treatment
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.
Measured: Every 3 months for 18-month duration of treatment
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.
Measured: Every 3 months for 18-month duration of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Jan 2016
- Primary completion4 Jan 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis S Lee, M.D., PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329677
- Sponsor's protocol ID
- 1412015726
- Status last verified
- Feb 2024
- First submitted
- 30 Oct 2017
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 18-Month Psychotherapy of Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT03329677
- Acronym / sponsor ID
- 1412015726
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transference-focused Psychotherapy (TFP) | Experimental | Other: Transference-focused Psychotherapy (TFP)Transference-focused psychotherapy is a psychodynamic talk therapy utilized in treating borderline personality disorder in men and women. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- We are recruiting female patients between the ages of 18-35 who meet DSM criteria for BPD.
Key exclusion criteria (7 listed)
- We are excluding patients who meet the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Transference-focused Psychotherapy (TFP) |
Primary outcome
Social Adjustment Scale (SAS; Weissman, 1971)
Time frame: Every 3 months for 18-month duration of treatment
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.
Brief Symptom Inventory (BSI; Derogatis, 1993)
Time frame: Every 3 months for 18-month duration of treatment
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.
Overt Aggression Scale (OAS-M; Coccaro et al., 1991)
Time frame: Every 3 months for 18-month duration of treatment
The OAS-M is a clinician-rated scale that characterizes aggressive behavior within the past week based on observation and self-report.
3 secondary outcomes
Affective Lability Scale (ALS; Harvey et al., 1989)
Time frame: Every 3 months for 18-month duration of treatment
State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999)
Time frame: Every 3 months for 18-month duration of treatment
Reflective Function Questionnaire (RFQ; Fonagy & Luyten, 2009)
Time frame: Every 3 months for 18-month duration of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis S Lee, M.D., PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transference-focused Psychotherapy (TFP) in people with Borderline Personality Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Adjustment Scale (SAS; Weissman, 1971) (time frame: Every 3 months for 18-month duration of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.