Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Self Mutilation; Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 4

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      the study will be slowly withdrawn from the medications over a period of 2 to 6 weeks.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.
    

Intervention name(s): Fluoxetine; Dialectical Behavior Therapy; Supportive psychotherapy
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated; 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 therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
Other intervention name(s): Prozac; DBT
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: suicide; self-mutilation; fluoxetine; placebo; dialectical behavior therapy; supportive therapy