Clinical trial NCT01952405: 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
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2013-09-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Suicide Attempt Self-Injury Interview (SASII)
timeFrame: 4 months, 8 months and 12 months
Secondary outcomes:
measure: Borderline Personality Disorder Subscale
timeFrame: 4 months, 8 months and 12 months
measure: Borderline Symptom Checklist (BSL-23)
timeFrame: 4 months, 8 months and 12 months
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: 4 months, 8 months and 12 months
measure: Symptom Checklist-90-Revised (SCL-90-R)
timeFrame: 4 months , 8 months and 12 months
measure: Beck Scale for Suicide Ideation (BSSI)
timeFrame: 4 months , 8months and 12 months
measure: Beck Hopelessness Scale (BHS)
timeFrame: 4 months, 8 months and 12months
measure: Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF)
timeFrame: 4 months, 8 months and 12 months
measure: Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I)
timeFrame: 4 months, 8 months and 12 months
measure: Brief Disability Questionnaire (BDQ)
timeFrame: 4 months, 8 months and 12 months
measure: Treatment History Interview (THI)
timeFrame: 4 months, 8 months and 12 months
Other outcomes:
measure: The SCAN (Schedules for Clinical Assessment in Neuropsychiatry)
timeFrame: baseline assessment(0 month) and post-treatment (12-month)
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Department of Medical Research, Mackay Memorial Hospital
name: Chie Pein Chen, PHD
role: STUDY_DIRECTOR
References:
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.