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Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT01952405
Recruitment Status : Completed
First Posted : September 30, 2013
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Shen-Ing,Liu, Mackay Memorial Hospital

Tracking Information
First Submitted Date  ICMJE September 6, 2013
First Posted Date  ICMJE September 30, 2013
Last Update Posted Date March 6, 2017
Actual Study Start Date  ICMJE May 18, 2013
Actual Primary Completion Date February 24, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01952405 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 27, 2013)
The SCAN (Schedules for Clinical Assessment in Neuropsychiatry) [ Time Frame: baseline assessment(0 month) and post-treatment (12-month) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder
Official Title  ICMJE Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder: a Controlled Trial in Taiwan
Brief 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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Borderline Personality Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Dialectical behavior therapy (DBT)
  • 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.
    Intervention: Behavioral: Dialectical behavior therapy (DBT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2013)
180
Actual Study Completion Date  ICMJE February 24, 2017
Actual Primary Completion Date February 24, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01952405
Other Study ID Numbers  ICMJE NSC102-2314-B-195-002-My3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shen-Ing,Liu, Mackay Memorial Hospital
Study Sponsor  ICMJE Mackay Memorial Hospital
Collaborators  ICMJE National Science Council, Taiwan
Investigators  ICMJE
Study Director: Chie Pein Chen, PHD Department of Medical Research, Mackay Memorial Hospital
PRS Account Mackay Memorial Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP