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Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Shen-Ing,Liu, Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01952405
First received: September 6, 2013
Last updated: March 2, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Borderline Personality Disorder
Behavioral: Dialectical behavior therapy (DBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder: a Controlled Trial in Taiwan

Resource links provided by NLM:


Further study details as provided by Mackay Memorial Hospital:

Primary Outcome Measures:
  • Suicide Attempt Self-Injury Interview (SASII) [ Time Frame: 4 months, 8 months and 12 months ]
    change from baseline in Suicide Attempt Self-Injury Interview at 4 months, 8 months and 12 months


Secondary Outcome Measures:
  • Borderline Personality Disorder Subscale [ Time Frame: 4 months, 8 months and 12 months ]
    Borderline Personality Disorder Subscale (Chinese version) of the Structured Clinical Interview for DSM-IV axis II Personality Disorders ((SCID-II)

  • Borderline Symptom Checklist (BSL-23) [ Time Frame: 4 months, 8 months and 12 months ]
  • The Patient Health Questionnaire (PHQ-9) [ Time Frame: 4 months, 8 months and 12 months ]
  • Symptom Checklist-90-Revised (SCL-90-R) [ Time Frame: 4 months , 8 months and 12 months ]
  • Beck Scale for Suicide Ideation (BSSI) [ Time Frame: 4 months , 8months and 12 months ]
  • Beck Hopelessness Scale (BHS) [ Time Frame: 4 months, 8 months and 12months ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF) [ Time Frame: 4 months, 8 months and 12 months ]
  • Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I) [ Time Frame: 4 months, 8 months and 12 months ]
  • Brief Disability Questionnaire (BDQ) [ Time Frame: 4 months, 8 months and 12 months ]
  • Treatment History Interview (THI) [ Time Frame: 4 months, 8 months and 12 months ]

Other Outcome Measures:
  • The SCAN (Schedules for Clinical Assessment in Neuropsychiatry) [ Time Frame: baseline assessment(0 month) and post-treatment (12-month) ]

Enrollment: 60
Actual Study Start Date: May 18, 2013
Study Completion Date: February 24, 2017
Primary Completion Date: February 24, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dialectical behavior therapy
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)
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.
Placebo Comparator: alternative psychotherapy
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)
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.

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952405

Locations
Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Mackay Memorial Hospital
National Science Council, Taiwan
Investigators
Study Director: Chie Pein Chen, PHD Department of Medical Research, Mackay Memorial Hospital
  More Information

Responsible Party: Shen-Ing,Liu, Senior Visiting Staff, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01952405     History of Changes
Other Study ID Numbers: NSC102-2314-B-195-002-My3
Study First Received: September 6, 2013
Last Updated: March 2, 2017

Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders

ClinicalTrials.gov processed this record on April 28, 2017