Overview

This trial is active, not recruiting.

Condition borderline personality disorder
Treatment dialectical behavior therapy (dbt)
Phase phase 3
Sponsor Mackay Memorial Hospital
Collaborator National Science Council, Taiwan
Start date September 2013
End date September 2016
Trial size 60 participants
Trial identifier NCT01952405, NSC102-2314-B-195-002-My3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
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)
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.
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.

Primary Outcomes

Measure
Suicide Attempt Self-Injury Interview (SASII)
time frame: 4 months, 8 months and 12 months

Secondary Outcomes

Measure
Borderline Personality Disorder Subscale
time frame: 4 months, 8 months and 12 months
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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder: a Controlled Trial in Taiwan
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mackay Memorial Hospital.