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Hope for the Chronically Suicidal Patient

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ClinicalTrials.gov Identifier: NCT00154154
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 12, 2012
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Shelley McMain, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Behavioral: General Psychiatric Management Behavioral: Dialectical Behaviour Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2002
Actual Primary Completion Date : June 2007
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A
General Psychiatric Management
Behavioral: General Psychiatric Management
General Psychiatric Management (GPM) condition consisting of a structured algorithmic medication intervention plus psychosocial counseling.

Experimental: 2
Dialectal Behaviour Therapy
Behavioral: Dialectical Behaviour Therapy
Modification of behaviours achieved with reframing thoughts and impulses




Primary Outcome Measures :
  1. Parasuicidal behaviour [ Time Frame: intermittent ]

Secondary Outcome Measures :
  1. Psychiatric hospitalization [ Time Frame: intermittent ]
  2. Psychiatric symptoms [ Time Frame: intermittent ]
  3. Treatment retention [ Time Frame: intermittent ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154154


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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shelley McMain, Head, Borderline Personality Disorder Clinic, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00154154     History of Changes
Other Study ID Numbers: CIHR: #200204MCT-101123
CIHR: #200204MCT-101123
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Shelley McMain, 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:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders