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

• ClinicalTrials.gov Identifier: NCT00533117
• Recruitment Status: Completed
• First Posted: September 21, 2007
• Results First Posted: August 28, 2017
• Last Update Posted: January 5, 2024
• Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Beth Brodsky, New York State Psychiatric Institute

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 Participants taking psychiatric medications prior to the study will be slowly withdrawn from the medications over a period of 2 to 6 weeks.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 (Clinical Trial)
• 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: March 2001
• Actual Primary Completion Date: January 2008
• Actual Study Completion Date: December 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 Name: 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 Name: 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 Name: 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 Name: 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 [ Time Frame: 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

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

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

Contacts and Locations

Locations

United States, New York

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Beth Brodsky, Associate Director, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00533117
• Other Study ID Numbers: #5401R; R01MH061017-02 ( U.S. NIH Grant/Contract )
• First Posted: September 21, 2007
• Results First Posted: August 28, 2017
• Last Update Posted: January 5, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Beth Brodsky, 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; Mental Disorders; Wounds and Injuries; Self-Injurious Behavior; Behavioral Symptoms; Fluoxetine; Selective Serotonin Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors