Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder

NCT ID: NCT01952405

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-18
• Study Completion Date: 2017-02-24

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.

Conditions

Borderline Personality Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dialectical behavior therapy (DBT)

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Dialectical behavior therapy (DBT)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shen-Ing,Liu

Senior Visiting Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chie Pein Chen, PHD

Role: STUDY_DIRECTOR

Department of Medical Research, Mackay Memorial Hospital

Locations

Mackay Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 33884617 (View on PubMed)

Related Links

http://grbsearch.stpi.narl.org.tw/GRB/quickSearch.jsp

Click here for more information about this study

Other Identifiers

NSC102-2314-B-195-002-My3

Identifier Type: -

Identifier Source: org_study_id