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Hope for the Chronically Suicidal Patient
This study is ongoing, but not recruiting participants.
First Received: September 7, 2005   Last Updated: June 20, 2008   History of Changes
Sponsor: Centre for Addiction and Mental Health
Collaborators: Canadian Institutes of Health Research (CIHR)
St. Michael's Hospital, Toronto
Information provided by: Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00154154
  Purpose

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.


Condition Intervention
Borderline Personality Disorder
Behavioral: General Psychiatric Management
Behavioral: Dialectical Behaviour Therapy

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Hope for the Chronically Suicidal Patient: Evaluating the Clinical and Health Services Impact of Dialectical Behaviour Therapy in Individuals With Borderline Personality Disorder

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Parasuicidal behaviour [ Time Frame: intermittent ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Psychiatric hospitalization [ Time Frame: intermittent ] [ Designated as safety issue: No ]
  • Psychiatric symptoms [ Time Frame: intermittent ] [ Designated as safety issue: No ]
  • Treatment retention [ Time Frame: intermittent ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: October 2002
Estimated Study Completion Date: September 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
General Psychiatric Management
Behavioral: General Psychiatric Management
General Psychiatric Management (GPM) condition consisting of a structured algorithmic medication intervention plus psychosocial counseling.
2: Experimental
Dialectal Behaviour Therapy
Behavioral: Dialectical Behaviour Therapy
Modification of behaviours achieved with reframing thoughts and impulses

Detailed Description:

Suicide, a major cause of death worldwide, is a serious public health problem. Forty percent of individuals who commit suicide meet diagnostic criteria for a personality disorder and an even higher percent of those attempting suicide have a personality disorder . Borderline personality disorder (BPD) is highly associated with parasuicidal behaviour. Parasuicidal behaviour refers to suicide attempts or other self-injurious behaviour and is a risk factor for completed suicide. Approximately 69% - 80% of people diagnosed with BPD have committed at least one act of self-harm. Estimates of completed suicides in this population are about 9%, with this rate quadrupling for patients who meet 8 or more of the 9 DSM criteria for BPD.

Chronically suicidal behaviour in people with BPD is estimated to be among the most expensive psychiatric disorders to treat. While there is an extensive anecdotal literature on the treatment of this population, clinical outcomes have been dismal and treatment evidence based on well-designed trials is sparse. Dialectical Behavior Therapy (DBT), a broad-based cognitive-behavioral therapy (CBT), has recently shown promise in the treatment of this population. DBT is being widely adopted in the treatment of this disorder despite its limited empirical base. To date, there are few studies on DBT and no replications of the original research on DBT by researchers independent of the treatment developer.

The aim of this study is to evaluate the clinical and cost effectiveness of DBT for the treatment of parasuicidal individuals with BPD compared to a General Psychiatric Management (GPM) control condition involving a structured algorithm medication intervention plus psychosocial support. This study will compare the following outcome measures in participants who receive Dialectical Behavior Therapy versus General Psychiatric Management, Best Practices during a one-year treatment interval and two-year follow-up: (1) frequency and severity of parasuicidal behaviours ; (2) number of self-harm episodes (3) improvement in quality of life (4) cost effectiveness.

Hypotheses:(1) Patients in the DBT condition will show greater reductions in the frequency and severity of parasuicidal behaviours compared to patients in the GPM condition during a one-year treatment interval and two-year follow-up; (2) Compared to GPM, DBT will result in a greater reduction in the number of self-harm episodes and a greater improvement in quality of life but will have a higher direct cost. However, because DBT will result in significant offsetting reductions in other health service costs, the incremental cost-effectiveness ratios will fall within the range of many accepted medical interventions.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00154154

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Shelley F. McMain, PhD Centre for Addiction and Mental Health
  More Information

Additional Information:
Publications:
American Psychiatric Association (2001). Diagnostic and Statistical Manual of Mental Disorders. Washington DC: American Psychiatric Association.
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.
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. No abstract available.
Cowdry RW, Pickar D, Davies R. Symptoms and EEG findings in the borderline syndrome. Int J Psychiatry Med. 1985-86;15(3):201-11.
Gunderson, J.G. (1984) Borderline Personality Disorder. Washington DC: American Psychiatric Press.
Linehan,M.M. (1993). Cognitive-Behavorial Treatment of Borderline Personality Disorder. New York: The Guilford Press.
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.
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.
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
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. No abstract available.
Scheel,K. The empirical basis of dialectical behavioral therapy: Summary, critique and implications. Clinical Psychology-Science and Practice,2000, 7, 68-86.
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

Responsible Party: CAMH ( Dr. Shelley McMain )
Study ID Numbers: CIHR: #200204MCT-101123, CIHR: #200204MCT-101123
Study First Received: September 7, 2005
Last Updated: June 20, 2008
ClinicalTrials.gov Identifier: NCT00154154     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
borderline personality disorder
BPD
treatment
dialectical behavior therapy
DBT
general Psychiatric management
GPM
suicide
parasuicide
randomized control trials

Additional relevant MeSH terms:
Pathologic Processes
Disease
Mental Disorders
Borderline Personality Disorder
Personality Disorders

ClinicalTrials.gov processed this record on November 25, 2009