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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH061017-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.
Borderline personality disorder (BPD) can be a serious and very complex condition. BPD affects 2% to 3% of the population and is more commonly diagnosed in young women. BPD is characterized by mood swings, impulsive behavior, difficulty controlling emotions, and acting out inappropriately either through self-harm or attempts of suicide. Other illnesses such as depression and anxiety are also very common in people diagnosed with BPD. Various treatments exist that aim to reduce self-harm and suicide among people with BPD. Dialectical behavior therapy (DBT), an outpatient behavioral therapy shown to help self-injurious patients with BPD, has become a popular treatment. Another useful treatment, the antidepressant fluoxetine, can help to regulate mood and diminish suicidal or self-destructive urges. Although combination treatments of DBT and fluoxetine are common, little research has been conducted on the effectiveness of this kind of combined treatment. The purpose of this study is to determine whether DBT and fluoxetine are more effective combined or alone in treating people with BPD.
All participants in this double-blind study will receive a psychiatric and medication evaluation prior to starting treatment. Participants taking psychiatric medications prior to the study will be slowly withdrawn from the medications over a period of 2 to 6 weeks. Psychological interviews and self-report questionnaires will be administered, taking approximately 5 to 10 hours to complete. Once all preliminary interviews and evaluations have been completed, each participant will be randomly assigned to one of the four following treatment groups:
All patients participating in this study will continue treatment for 12 months and will be evaluated bimonthly. After 12 months, participants will undergo neuropsychological testing to identify any changes that occurred over the last year. The clinical status of each participant will also be assessed at 18 and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dialectical Behavior Therapy Fluoxetine | Experimental | Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy (CBT) targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, a selective serotonin reuptake inhibitor (SSRI) that is given in standard dosing 20, 40, 60, 80 mg for 12 months. |
|
| Dialectical Behavior Therapy placebo | Placebo Comparator | Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months. |
|
| Supportive therapy Fluoxetine | Experimental | Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months. |
|
| Supportive therapy placebo | Active Comparator | Supportive psychotherapy and placebo See above for descriptions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Suicide Attempts | Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase) | Assessed bimonthly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Stanley, PhD | Research Foundation for Mental Hygiene/Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33884617 | Derived | Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2. | |
| 32368793 | Derived | Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2. |
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91 participants signed consent, 86 were randomized, 11 participants dropped out prior to treatment start. Therefore 75 participants remained, accounting for the discrepancy between the original 91 participants and the final count of 75. Participants were washed out of all psychotropic medications. Benzodiazepine is permitted for sleep.
Participants were recruited from the emergency department, clinician referrals and advertisements. Recruitment period ended 6 months prior to study end date.
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| ID | Title | Description |
|---|---|---|
| FG000 | DBT Fluoxetine | Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months. Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group. |
| FG001 | DBT Placebo | Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months. Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group. |
| FG002 | Supportive Therapy Fluoxetine | Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months. Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress. |
| FG003 | Supportive Therapy Placebo | Supportive psychotherapy and placebo See above for descriptions. Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Suicidal and/or self injuring individuals with borderline personality disorder.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dialectical Behavior Therapy Fluoxetine | Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months. Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Suicide Attempts | Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase) | Suicidal and/or self injuring individuals with borderline personality disorder. | Posted | Number | suicide attempt | Assessed bimonthly |
|
During study enrollment (12 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dialectical Behavior Therapy With Fluoxetine | Participants received 12 months of DBT therapy with fluoxetine with weekly medication management sessions (double blind). Primary planned analyses were with supportive therapy/placebo. Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups. Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo, to test the hypothesis regarding differences in the primary outcome measure between the two medication groups. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization or ED visitn | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Stanley | NYSPI | 6467747582 | bhs2@columbia.edu |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| D000077252 | Dialectical Behavior Therapy |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001521 | Behavior Therapy |
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|
| Dialectical Behavior Therapy | Behavioral | Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group. |
|
|
| Supportive psychotherapy | Behavioral | Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress. |
|
| BG001 | Dialectical Behavior Therapy Placebo | Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months. Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group. |
| BG002 | Supportive Therapy Fluoxetine | Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months. Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress. |
| BG003 | Supportive Therapy Placebo | Supportive psychotherapy and placebo See above for descriptions. Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Supportive Therapy With Fluoxetine | Participants received 12 months of ST with fluoxetine medication with weekly medication visits (medication condition double blind) |
| OG003 | Supportive Therapy With Placebo | Participants received 12 months of ST placebo medication with weekly medication visits (medication condition double blind) |
|
|
| 1 |
| 18 |
| 0 |
| 18 |
| EG001 | Supportive Therapy With Fluoxetine | Participants received 12 months of supportive therapy with fluoxetine weekly medication management sessions(double blind). Planned analyses were with supportive therapy/placebo. Also, fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups. Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo. to test the hypothesis regarding differences in the primary outcome measure between the two medication groups.. | 2 | 20 | 0 | 20 |
| EG002 | Dialectical Behavior Therapy With Placebo | Participants received 12 months of DBT therapy with placebo medication with weekly medication management sessions (double blind). Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups.Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo, to test the hypothesis regarding differences in the primary outcome measure between the two medication groups. | 0 | 19 | 0 | 19 |
| EG003 | Supportive Therapy With Placebo | Participants received 12 months of supportive therapy with placebo weekly medication management sessions(double blind). This condition served as the control condition. Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups.Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo, to test the hypothesis regarding differences in the primary outcome measure between the two medication groups. | 0 | 18 | 0 | 18 |
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| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |