Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder

Sponsor
Mackay Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01952405
Collaborator
National Science Council, Taiwan (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dialectical behavior therapy (DBT)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder: a Controlled Trial in Taiwan
Actual Study Start Date :
May 18, 2013
Actual Primary Completion Date :
Feb 24, 2017
Actual Study Completion Date :
Feb 24, 2017

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Suicide Attempt Self-Injury Interview (SASII) [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

  1. Borderline Personality Disorder Subscale [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)

  2. Borderline Symptom Checklist (BSL-23) [4 months, 8 months and 12 months]

  3. The Patient Health Questionnaire (PHQ-9) [4 months, 8 months and 12 months]

  4. Symptom Checklist-90-Revised (SCL-90-R) [4 months , 8 months and 12 months]

  5. Beck Scale for Suicide Ideation (BSSI) [4 months , 8months and 12 months]

  6. Beck Hopelessness Scale (BHS) [4 months, 8 months and 12months]

  7. Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF) [4 months, 8 months and 12 months]

  8. Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I) [4 months, 8 months and 12 months]

  9. Brief Disability Questionnaire (BDQ) [4 months, 8 months and 12 months]

  10. Treatment History Interview (THI) [4 months, 8 months and 12 months]

Other Outcome Measures

  1. The SCAN (Schedules for Clinical Assessment in Neuropsychiatry) [baseline assessment(0 month) and post-treatment (12-month)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Shen-Ing,Liu, Senior Visiting Staff, Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01952405
Other Study ID Numbers:
  • NSC102-2314-B-195-002-My3
First Posted:
Sep 30, 2013
Last Update Posted:
Mar 6, 2017
Last Verified:
Mar 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 6, 2017