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

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Dialectical Behavior Therapy
Supportive psychotherapy
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring suicide, self-mutilation, fluoxetine, placebo, dialectical behavior therapy, supportive therapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Active Comparator

Arm Label

Dialectical Behavior Therapy Fluoxetine

Dialectical Behavior Therapy placebo

Supportive therapy Fluoxetine

Supportive therapy placebo

Arm Description

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.

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 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 psychotherapy and placebo See above for descriptions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 19, 2007
Last Updated
January 14, 2020
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00533117
Brief Title
Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder
Official Title
Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
suicide, self-mutilation, fluoxetine, placebo, dialectical behavior therapy, supportive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Stanley, PhD
Organizational Affiliation
Research Foundation for Mental Hygiene/Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33884617
Citation
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.
Results Reference
derived
PubMed Identifier
32368793
Citation
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.
Results Reference
derived

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

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