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Completed

NCT Number: NCT01952405

Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mackay Memorial Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialectical Behavior Therapy (DBT)

Behavioral

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.

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. Borderline Symptom Checklist (BSL-23)

    Time frame: 4 months, 8 months and 12 months

  3. The Patient Health Questionnaire (PHQ-9)

    Time frame: 4 months, 8 months and 12 months

  4. Symptom Checklist-90-Revised (SCL-90-R)

    Time frame: 4 months , 8 months and 12 months

  5. Beck Scale for Suicide Ideation (BSSI)

    Time frame: 4 months , 8months and 12 months

  6. Beck Hopelessness Scale (BHS)

    Time frame: 4 months, 8 months and 12months

  7. Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF)

    Time frame: 4 months, 8 months and 12 months

  8. Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I)

    Time frame: 4 months, 8 months and 12 months

  9. Brief Disability Questionnaire (BDQ)

    Time frame: 4 months, 8 months and 12 months

  10. Treatment History Interview (THI)

    Time frame: 4 months, 8 months and 12 months

Other outcomes

  1. The SCAN (Schedules for Clinical Assessment in Neuropsychiatry)

    Time frame: baseline assessment(0 month) and post-treatment (12-month)

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2013
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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