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Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Dialectical behavior therapy (DBT)
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dialectical behavior therapy

alternative psychotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Suicide Attempt Self-Injury Interview (SASII)
change from baseline in Suicide Attempt Self-Injury Interview at 4 months, 8 months and 12 months

Secondary Outcome Measures

Borderline Personality Disorder Subscale
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)
The Patient Health Questionnaire (PHQ-9)
Symptom Checklist-90-Revised (SCL-90-R)
Beck Scale for Suicide Ideation (BSSI)
Beck Hopelessness Scale (BHS)
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF)
Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I)
Brief Disability Questionnaire (BDQ)
Treatment History Interview (THI)

Full Information

First Posted
September 6, 2013
Last Updated
March 2, 2017
Sponsor
Mackay Memorial Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01952405
Brief Title
Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder
Official Title
Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder: a Controlled Trial in Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 18, 2013 (Actual)
Primary Completion Date
February 24, 2017 (Actual)
Study Completion Date
February 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialectical behavior therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
alternative psychotherapy
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Dialectical behavior therapy (DBT)
Intervention Description
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 Outcome Measure Information:
Title
Suicide Attempt Self-Injury Interview (SASII)
Description
change from baseline in Suicide Attempt Self-Injury Interview at 4 months, 8 months and 12 months
Time Frame
4 months, 8 months and 12 months
Secondary Outcome Measure Information:
Title
Borderline Personality Disorder Subscale
Description
Borderline Personality Disorder Subscale (Chinese version) of the Structured Clinical Interview for DSM-IV axis II Personality Disorders ((SCID-II)
Time Frame
4 months, 8 months and 12 months
Title
Borderline Symptom Checklist (BSL-23)
Time Frame
4 months, 8 months and 12 months
Title
The Patient Health Questionnaire (PHQ-9)
Time Frame
4 months, 8 months and 12 months
Title
Symptom Checklist-90-Revised (SCL-90-R)
Time Frame
4 months , 8 months and 12 months
Title
Beck Scale for Suicide Ideation (BSSI)
Time Frame
4 months , 8months and 12 months
Title
Beck Hopelessness Scale (BHS)
Time Frame
4 months, 8 months and 12months
Title
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF)
Time Frame
4 months, 8 months and 12 months
Title
Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I)
Time Frame
4 months, 8 months and 12 months
Title
Brief Disability Questionnaire (BDQ)
Time Frame
4 months, 8 months and 12 months
Title
Treatment History Interview (THI)
Time Frame
4 months, 8 months and 12 months
Other Pre-specified Outcome Measures:
Title
The SCAN (Schedules for Clinical Assessment in Neuropsychiatry)
Time Frame
baseline assessment(0 month) and post-treatment (12-month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chie Pein Chen, PHD
Organizational Affiliation
Department of Medical Research, Mackay Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
Links:
URL
http://grbsearch.stpi.narl.org.tw/GRB/quickSearch.jsp
Description
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Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder

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