Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mackay Memorial Hospital
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: January 7, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to test the hypothesis:

Primary hypothesis: Participants in the DBT 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 DBT group have improved treatment outcomes compared to participants in alternative treatment, including mental health service utilization, symptoms of borderline personality and depression symptoms, suicidal ideation and hopelessness, disability, and quality of life.


Condition Intervention Phase
Borderline Personality Disorder
Behavioral: Dialectical behavior therapy (DBT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • The Patient Health Questionnaire (PHQ-9) [ Time Frame: 4 months, 8 months and 12 months ] [ Designated as safety issue: No ]
  • Symptom Checklist-90-Revised (SCL-90-R) [ Time Frame: 4 months , 8 months and 12 months ] [ Designated as safety issue: No ]
  • Beck Scale for Suicide Ideation (BSSI) [ Time Frame: 4 months , 8months and 12 months ] [ Designated as safety issue: No ]
  • Beck Hopelessness Scale (BHS) [ Time Frame: 4 months, 8 months and 12months ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF) [ Time Frame: 4 months, 8 months and 12 months ] [ Designated as safety issue: No ]
  • Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I) [ Time Frame: 4 months, 8 months and 12 months ] [ Designated as safety issue: No ]
  • Brief Disability Questionnaire (BDQ) [ Time Frame: 4 months, 8 months and 12 months ] [ Designated as safety issue: No ]
  • Treatment History Interview (THI) [ Time Frame: 4 months, 8 months and 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The SCAN (Schedules for Clinical Assessment in Neuropsychiatry) [ Time Frame: baseline assessment(0 month) and post-treatment (12-month) ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: September 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: August 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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

Contacts
Contact: Hui-Chun Huang, MS 886-2-28094661 ext 3055 aihch@yahoo.com.tw

Locations
Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Hui-Chun Huang, MS    886-2-28094661 ext 3055    aihch@yahoo.com.tw   
Principal Investigator: Shen-Ing Liu, PHD         
Sponsors and Collaborators
Mackay Memorial Hospital
National Science Council, Taiwan
  More Information

No publications provided

Responsible Party: Shen-Ing,Liu, Doctor, 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: January 7, 2014
Health Authority: Taiwan: Ministry of Health and Welfare

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014