NCT00154154

Brief Summary

The aim of this study is to evaluate the clinical and cost effectiveness of Dialectical Behavior Therapy (DBT) for chronically suicidal behavior in individuals diagnosed with borderline personality disorder (BPD). Recent investigations of DBT have yielded positive results and have challenged the widely held opinion that the prognosis for this condition is poor. This study will consist of a two-arm randomized controlled trial that will compare DBT with a General Psychiatric Management (GPM) condition consisting of a structured algorithmic medication intervention plus psychosocial counseling. One-hundred and eighty participants will be randomly assigned to either DBT or to the GPM condition. Clinical outcomes will be assessed by changes in: (1) parasuicidal behaviour; (2) treatment retention; (3) psychiatric symptomatology; (4) anger expression; (5) social functioning and (6) health status. Cost outcomes will include an analysis of health service utilization. Clinical and cost evaluations will occur at 4-month intervals over the course of the one-year treatment and over a two-year follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

October 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

December 12, 2012

Status Verified

December 1, 2012

Enrollment Period

4.7 years

First QC Date

September 7, 2005

Last Update Submit

December 11, 2012

Conditions

Borderline Personality Disorder

Keywords

borderline personality disorderBPDtreatmentdialectical behavior therapyDBTgeneral Psychiatric managementGPMsuicideparasuiciderandomized control trials

Outcome Measures

Primary Outcomes (1)

  • Parasuicidal behaviour

    intermittent

Secondary Outcomes (3)

  • Psychiatric hospitalization

    intermittent

  • Psychiatric symptoms

    intermittent

  • Treatment retention

    intermittent

Study Arms (2)

A

ACTIVE COMPARATOR

General Psychiatric Management

Behavioral: General Psychiatric Management

2

EXPERIMENTAL

Dialectal Behaviour Therapy

Behavioral: Dialectical Behaviour Therapy

Interventions

General Psychiatric ManagementBEHAVIORAL

General Psychiatric Management (GPM) condition consisting of a structured algorithmic medication intervention plus psychosocial counseling.

A
Dialectical Behaviour TherapyBEHAVIORAL

Modification of behaviours achieved with reframing thoughts and impulses

2

Eligibility Criteria

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

You may qualify if:

  • Meet DSM-IV criteria for BPD
  • Between 18-60 years of age
  • Have had two parasuicide episodes in the past five years with one occurring in the past 3 months
  • Have had OHIP coverage for 1 year or more
  • Literate in English
  • Provide informed consent to participate in the study

You may not qualify if:

  • Current active substance dependence disorder
  • Psychotic disorder,bipolar I disorder, or dementia
  • Evidence of an organic brain syndrome or mental retardation
  • A chronic or serious physical health problem that will require hospitalization within the next year (e.g. cancer)
  • A medical condition that would preclude the psychiatric medication regimen in the GPM condition
  • Definite plans to leave the province in the next 2 years
  • Currently engaged in DBT or GPM at St. Michael's Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (17)

  • American Psychiatric Association (2001). Diagnostic and Statistical Manual of Mental Disorders. Washington DC: American Psychiatric Association.

    BACKGROUND

  • American Psychiatric Association Practice Guidelines. Practice guideline for the treatment of patients with borderline personality disorder. American Psychiatric Association. Am J Psychiatry. 2001 Oct;158(10 Suppl):1-52. No abstract available.

    PMID: 11665545BACKGROUND

  • Clarkin JF, Widiger TA, Frances A, Hurt SW, Gilmore M. Prototypic typology and the borderline personality disorder. J Abnorm Psychol. 1983 Aug;92(3):263-75. doi: 10.1037//0021-843x.92.3.263. No abstract available.

    PMID: 6619404BACKGROUND

  • Cowdry RW, Pickar D, Davies R. Symptoms and EEG findings in the borderline syndrome. Int J Psychiatry Med. 1985-1986;15(3):201-11. doi: 10.2190/3y0c-hauk-04jx-gbpn.

    PMID: 4066162BACKGROUND

  • Gunderson, J.G. (1984) Borderline Personality Disorder. Washington DC: American Psychiatric Press.

    BACKGROUND

  • Linehan,M.M. (1993). Cognitive-Behavorial Treatment of Borderline Personality Disorder. New York: The Guilford Press.

    BACKGROUND

  • Linehan, M.M. (1981). A social-behavioral analysis of suicide and parasuicide: Implications for clinical assessment and treatment. In H. Glazer & J.F. Clarkin (Eds.),Depression: Behavioral and Directive Intervention Strategies (pp. 29-294). New York: Garland.

    BACKGROUND

  • Linehan,MM., Heard, HL (1999). Borderline personality disorder: costs, course and treatment outcomes. In N. Mille & K. Magruder (Eds.), The cost-effectiveness of psychotherapy: Guide for practitioners, researchers and policy makers. New York: Oxford University Press, pp.291-305.

    BACKGROUND

  • Moscicki, E.K. (1999). Epidemiology of Suicide. In D.G. Jacobs (Ed)., The Harvard Medical School Guide to Suicde Assessment and Intervention. Josssey-Bass Publishers: San Francisco

    BACKGROUND

  • Paris J, Brown R, Nowlis D. Long-term follow-up of borderline patients in a general hospital. Compr Psychiatry. 1987 Nov-Dec;28(6):530-5. doi: 10.1016/0010-440x(87)90019-8. No abstract available.

    PMID: 3691077BACKGROUND

  • Scheel,K. The empirical basis of dialectical behavioral therapy: Summary, critique and implications. Clinical Psychology-Science and Practice,2000, 7, 68-86.

    BACKGROUND

  • Stone, H.H. (1989). The course of borderlne personality disorder. In A. Tasman, T.E. Hales, & A.J. Frances (Eds.), American Psychiatric Press Review of Psychiatry, 8, (pp.103-122). Washington DC:American Psychiatric Press

    BACKGROUND

  • 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.

    PMID: 33884617DERIVED

  • Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

    PMID: 32368793DERIVED

  • Runarsdottir V, Hansdottir I, Tyrfingsson T, Einarsson M, Dugosh K, Royer-Malvestuto C, Pettinati H, Khalsa J, Woody GE. Extended-Release Injectable Naltrexone (XR-NTX) With Intensive Psychosocial Therapy for Amphetamine-Dependent Persons Seeking Treatment: A Placebo-Controlled Trial. J Addict Med. 2017 May/Jun;11(3):197-204. doi: 10.1097/ADM.0000000000000297.

    PMID: 28379861DERIVED

  • McMain SF, Guimond T, Streiner DL, Cardish RJ, Links PS. Dialectical behavior therapy compared with general psychiatric management for borderline personality disorder: clinical outcomes and functioning over a 2-year follow-up. Am J Psychiatry. 2012 Jun;169(6):650-61. doi: 10.1176/appi.ajp.2012.11091416.

    PMID: 22581157DERIVED

  • McMain SF, Links PS, Gnam WH, Guimond T, Cardish RJ, Korman L, Streiner DL. A randomized trial of dialectical behavior therapy versus general psychiatric management for borderline personality disorder. Am J Psychiatry. 2009 Dec;166(12):1365-74. doi: 10.1176/appi.ajp.2009.09010039. Epub 2009 Sep 15.

    PMID: 19755574DERIVED

Related Links

MeSH Terms

Conditions

Borderline Personality DisorderSuicideSuicide, Attempted

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Shelley F. McMain, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Borderline Personality Disorder Clinic

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

October 1, 2002

Primary Completion

June 1, 2007

Study Completion

April 1, 2009

Last Updated

December 12, 2012

Record last verified: 2012-12

Locations

CA(2)