Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952405
• Other study ID #: NSC102-2314-B-195-002-My3
• Status: Completed
• Phase: N/A
• First received: September 6, 2013
• Last updated: March 2, 2017
• Start date: May 18, 2013
• Est. completion date: February 24, 2017

Study information

• Verified date: March 2017
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 24, 2017
• Est. primary completion date: February 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Personality Disorders

Intervention

Behavioral:
• Dialectical behavior therapy (DBT)
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.

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Mackay Memorial Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The SCAN (Schedules for Clinical Assessment in Neuropsychiatry)		baseline assessment(0 month) and post-treatment (12-month)
Primary	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	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
Secondary	Borderline Symptom Checklist (BSL-23)		4 months, 8 months and 12 months
Secondary	The Patient Health Questionnaire (PHQ-9)		4 months, 8 months and 12 months
Secondary	Symptom Checklist-90-Revised (SCL-90-R)		4 months , 8 months and 12 months
Secondary	Beck Scale for Suicide Ideation (BSSI)		4 months , 8months and 12 months
Secondary	Beck Hopelessness Scale (BHS)		4 months, 8 months and 12months
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF)		4 months, 8 months and 12 months
Secondary	Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I)		4 months, 8 months and 12 months
Secondary	Brief Disability Questionnaire (BDQ)		4 months, 8 months and 12 months
Secondary	Treatment History Interview (THI)		4 months, 8 months and 12 months