NCT01952405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2017

Completed
Last Updated

March 6, 2017

Status Verified

March 1, 2017

Enrollment Period

3.8 years

First QC Date

September 6, 2013

Last Update Submit

March 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Suicide Attempt Self-Injury Interview (SASII)

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

    4 months, 8 months and 12 months

Secondary Outcomes (10)

  • Borderline Personality Disorder Subscale

    4 months, 8 months and 12 months

  • Borderline Symptom Checklist (BSL-23)

    4 months, 8 months and 12 months

  • The Patient Health Questionnaire (PHQ-9)

    4 months, 8 months and 12 months

  • Symptom Checklist-90-Revised (SCL-90-R)

    4 months , 8 months and 12 months

  • Beck Scale for Suicide Ideation (BSSI)

    4 months , 8months and 12 months

  • +5 more secondary outcomes

Other Outcomes (1)

  • The SCAN (Schedules for Clinical Assessment in Neuropsychiatry)

    baseline assessment(0 month) and post-treatment (12-month)

Study Arms (2)

Dialectical behavior therapy

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.

Behavioral: Dialectical behavior therapy (DBT)

alternative psychotherapy

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.

Behavioral: Dialectical behavior therapy (DBT)

Interventions

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 therapyalternative psychotherapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • meeting DSM-IV criteria for borderline personality disorder
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Chie Pein Chen, PHD

    Department of Medical Research, Mackay Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Visiting Staff

Study Record Dates

First Submitted

September 6, 2013

First Posted

September 30, 2013

Study Start

May 18, 2013

Primary Completion

February 24, 2017

Study Completion

February 24, 2017

Last Updated

March 6, 2017

Record last verified: 2017-03

Locations