Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder

Study Overview
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Brief Summary
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The purpose of this study is to test the hypothesis: Primary hypothesis: Participants in the dialectical behavior therapy group have greater reductions in the frequency and severity of suicidal and non-suicidal self-injurious behaviors compared to participants in the alternative treatment group. Secondary Hypotheses: Participants in dialectical behavior therapy group have improved treatment outcomes compared to participants in alternative treatment, including mental health service utilization, symptoms of borderline personality and depression symptoms, suicidal thought and hopelessness, disability, and quality of life.

Detailed Description
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This study will be a 3-year randomized control trial. Patients will be referred from any mental health services in Taipei area who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for Borderline Personality Disorder. Inclusion criteria include subjects who fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for Borderline Personality Disorder, 18-60 years of age, sign the informed consent, have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years, and at least one of which is in the 3 months preceding enrollment. The exclusion criteria include psychotic disorder, bipolar I disorder, severe physical illness, and mental retardation. Outcome measures will be obtained at pre-treatment, 4-month, 8-month and post-treatment (12-month) during 1-year protocol. Using semi-structured interview and a battery of self-report forms, a range of symptoms and behaviors associated with Borderline Personality Disorder will be assessed including suicidal thought, suicide attempt, depression, hopelessness, quality of life, disability, service utilization, and function. Measures are selected based on previous outcome studies of dialectical behavior therapy. Outcome variables will be evaluated by blinded assessors.

Official Title
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Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder: a Controlled Trial in Taiwan

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Behavioral: Dialectical behavior therapy (DBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meeting DSM-IV criteria for borderline personality disorder 18-60 years of age have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years, at least one episode of suicidal is in the 3 months preceding enrollment agreement to participate in evaluation of the program. Exclusion Criteria: bipolar I disorder, delirium, dementia, mental retardation, or a diagnosis of substance dependence in the preceding 30 days living outside of Taipei area having any serious medical condition likely to require hospitalization within the next year (e.g. cancer) and having plans to leave the Taipei area in the next 1 year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dialectical behavior therapy<br>Dialectical behavior therapy (DBT), developed by Marsha Linehan, has gained widespread popularity as a treatment for BPD, and its efficacy has been demonstrated in several trials. | Behavioral: Dialectical behavior therapy (DBT)<br>* Dialectical behavior therapy (DBT), developed by Marsha Linehan, has gained widespread popularity as a treatment for BPD, and its efficacy has been demonstrated in several trials.<br>|
| Placebo Comparator: alternative psychotherapy<br>The therapists of the alternative psychotherapy in the comparison group are asked to provide the type and dose of therapy that they believed is most suited to the patient, with a minimum of 1 scheduled individual session per week. Ancillary treatment could be prescribed as needed. Case management strategies are also available in the comparison group (alternative psychotherapy group). No restrictions are placed on ancillary pharmacotherapy in either condition. | Behavioral: Dialectical behavior therapy (DBT)<br>* Dialectical behavior therapy (DBT), developed by Marsha Linehan, has gained widespread popularity as a treatment for BPD, and its efficacy has been demonstrated in several trials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide Attempt Self-Injury Interview (SASII) | change from baseline in Suicide Attempt Self-Injury Interview at 4 months, 8 months and 12 months | 4 months, 8 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borderline Personality Disorder Subscale | Borderline Personality Disorder Subscale (Chinese version) of the Structured Clinical Interview for DSM-IV axis II Personality Disorders ((SCID-II) | 4 months, 8 months and 12 months | 
| Borderline Symptom Checklist (BSL-23) |  | 4 months, 8 months and 12 months | 
| The Patient Health Questionnaire (PHQ-9) |  | 4 months, 8 months and 12 months | 
| Symptom Checklist-90-Revised (SCL-90-R) |  | 4 months , 8 months and 12 months | 
| Beck Scale for Suicide Ideation (BSSI) |  | 4 months , 8months and 12 months | 
| Beck Hopelessness Scale (BHS) |  | 4 months, 8 months and 12months | 
| Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF) |  | 4 months, 8 months and 12 months | 
| Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I) |  | 4 months, 8 months and 12 months | 
| Brief Disability Questionnaire (BDQ) |  | 4 months, 8 months and 12 months | 
| Treatment History Interview (THI) |  | 4 months, 8 months and 12 months |