Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00533117
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 91
• Location: 1
• Arms: 4
• Duration (Months): 141
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder	Drug: Fluoxetine; Behavioral: Dialectical Behavior Therapy; Behavioral: Supportive psychotherapy	Phase 4

Detailed Description

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 Participants taking psychiatric medications prior to the study will be slowly withdrawn from the medications over a period of 2 to 6 weeks.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:

• Group 1 will receive DBT and fluoxetine (Prozac). DBT teaches patients new skills to replace old coping strategies such as suicide attempts and self-injury. Participants will work with an individual therapist for 1 hour a week to learn these new skills. This group will also be expected to keep a weekly diary that will discuss their current mood; suicidal and self-harming urges; and possible use of medications, drugs, and alcohol. Once a week participants will engage in a 90-minute skills training group to review the skills learned during therapy. Homework will be assigned between sessions to review these new strategies and skills. Participants will meet regularly with a psychiatrist to receive fluoxetine, discuss any side effects, and adjust dosage if necessary.

• Group 2 participants will receive DBT and placebo medication.

• Group 3 participants will receive supportive therapy and fluoxetine. Supportive therapy is nondirective and focuses on strengths, coping abilities, and current areas of difficulty in life in an unstructured format. Participants in this group will meet with an individual therapist each week for 50 minutes. Patients will also be assigned to a psychiatrist to receive fluoxetine every other week.

• Group 4 participants will receive supportive psychotherapy and placebo medication.

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder
• Study Start Date: Mar 1, 2001
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dialectical Behavior Therapy Fluoxetine 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.	Drug: Fluoxetine; Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated; Other Names: Prozac ; Behavioral: 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.; Other Names: DBT
Placebo Comparator: 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.	Behavioral: 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.; Other Names: DBT
Experimental: 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.	Drug: Fluoxetine; Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated; Other Names: Prozac ; Behavioral: Supportive psychotherapy; Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
Active Comparator: Supportive therapy placebo Supportive psychotherapy and placebo See above for descriptions.	Behavioral: Supportive psychotherapy; Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.

Outcome Measures

Primary Outcome Measures

1. Suicide Attempts [Assessed bimonthly]

   Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Meets criteria for diagnosis of borderline personality disorder

• History of at least one suicide attempt or self-mutilation episode 12 months prior to study entry

• Experiences continued urges to self-mutilate or attempt suicide

• Stable living situation

• Use of effective birth control if sexually active

• Clinically stable enough to tolerate placebo condition

• Not participating in other forms of treatment during the study

Exclusion Criteria:

• Any current organic mental syndromes, lifetime schizophrenic or bipolar disorders, psychotic disorders, or mental retardation

• Inability to complete psychiatric interview due to lack of cooperation or lack of comprehension

• Unable to tolerate fluoxetine or DBT

• Currently receiving treatment for an acute medical illness or other debilitating problem, including substance abuse or anorexia nervosa

• History of major depression lasting more than 3 months

• Current Hamilton depression score above 22 and not receiving treatment

• Pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Barbara Stanley, PhD, Research Foundation for Mental Hygiene/Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Barbara Stanley, Professor of Medical Psycholog, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00533117
• Other Study ID Numbers: #5401R; R01MH061017-02
• First Posted: Sep 21, 2007
• Last Update Posted: Jan 18, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Barbara Stanley, Professor of Medical Psycholog, New York State Psychiatric Institute: suicide; self-mutilation; fluoxetine; placebo; dialectical behavior therapy; supportive therapy
• Additional relevant MeSH terms: Self Mutilation; Personality Disorders; Borderline Personality Disorder; Fluoxetine

Study Results

Participant Flow

Recruitment Details	Participants were recruited from the emergency department, clinician referrals and advertisements. Recruitment period ended 6 months prior to study end date.
Pre-assignment Detail	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.

Arm/Group Title	DBT Fluoxetine	DBT Placebo	Supportive Therapy Fluoxetine	Supportive Therapy Placebo
Arm/Group Description	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.	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.	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.	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.
Period Title: Overall Study
STARTED	18	19	20	18
COMPLETED	14	14	14	13
NOT COMPLETED	4	5	6	5

Baseline Characteristics

Arm/Group Title	Dialectical Behavior Therapy Fluoxetine	Dialectical Behavior Therapy Placebo	Supportive Therapy Fluoxetine	Supportive Therapy Placebo	Total
Arm/Group Description	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.	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.	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.	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.	Total of all reporting groups
Overall Participants	18	19	20	18	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.6 (6.9)	29.1 (8.3)	32.3 (8.6)	31.8 (11.2)	30.2 (8.7)
Sex: Female, Male (Count of Participants)
Female	15 83.3%	13 68.4%	17 85%	13 72.2%	58 77.3%
Male	3 16.7%	6 31.6%	3 15%	5 27.8%	17 22.7%

Outcome Measures

1. Primary Outcome

Title	Suicide Attempts
Description	Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase)
Time Frame	Assessed bimonthly

Outcome Measure Data

Analysis Population Description

Suicidal and/or self injuring individuals with borderline personality disorder.

Arm/Group Title	Dialectical Behavior Therapy With Fluoxetine	Dialectical Behavior Therapy With Placebo	Supportive Therapy With Fluoxetine	Supportive Therapy With Placebo
Arm/Group Description	Participants received 12 months of DBT and Fluoxetine medication with weekly medication visits (medication condition double blind)	Participants received 12 months of DBT and placebo with weekly medication visits (medication condition double blind)	Participants received 12 months of ST with fluoxetine medication with weekly medication visits (medication condition double blind)	Participants received 12 months of ST placebo medication with weekly medication visits (medication condition double blind)
Measure Participants	18	19	20	18
Number [suicide attempt]	2	1	4	1

Adverse Events

Time Frame	During study enrollment (12 months)
Arm/Group Title	Dialectical Behavior Therapy With Fluoxetine		Supportive Therapy With Fluoxetine		Dialectical Behavior Therapy With Placebo		Supportive Therapy With Placebo
Arm/Group Description	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.		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..		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.		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.
All Cause Mortality
	Dialectical Behavior Therapy With Fluoxetine		Supportive Therapy With Fluoxetine		Dialectical Behavior Therapy With Placebo		Supportive Therapy With Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Dialectical Behavior Therapy With Fluoxetine		Supportive Therapy With Fluoxetine		Dialectical Behavior Therapy With Placebo		Supportive Therapy With Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/18 (5.6%)		2/20 (10%)		0/19 (0%)		0/18 (0%)
Psychiatric disorders
Hospitalization or ED visitn	1/18 (5.6%)	1	2/20 (10%)	2	0/19 (0%)	0	0/18 (0%)	0
Other (Not Including Serious) Adverse Events
	Dialectical Behavior Therapy With Fluoxetine		Supportive Therapy With Fluoxetine		Dialectical Behavior Therapy With Placebo		Supportive Therapy With Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/20 (0%)		0/19 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.