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Hope for the Chronically Suicidal Patient

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
General Psychiatric Management
Dialectical Behaviour Therapy
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring borderline personality disorder, BPD, treatment, dialectical behavior therapy, DBT, general Psychiatric management, GPM, suicide, parasuicide, randomized control trials

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St Michael's Hospital
  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

2

Arm Description

General Psychiatric Management

Dialectal Behaviour Therapy

Outcomes

Primary Outcome Measures

Parasuicidal behaviour

Secondary Outcome Measures

Psychiatric hospitalization
Psychiatric symptoms
Treatment retention

Full Information

First Posted
September 7, 2005
Last Updated
December 11, 2012
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR), Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00154154
Brief Title
Hope for the Chronically Suicidal Patient
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 Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR), Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
borderline personality disorder, BPD, treatment, dialectical behavior therapy, DBT, general Psychiatric management, GPM, suicide, parasuicide, randomized control trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
General Psychiatric Management
Arm Title
2
Arm Type
Experimental
Arm Description
Dialectal Behaviour Therapy
Intervention Type
Behavioral
Intervention Name(s)
General Psychiatric Management
Intervention Description
General Psychiatric Management (GPM) condition consisting of a structured algorithmic medication intervention plus psychosocial counseling.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behaviour Therapy
Intervention Description
Modification of behaviours achieved with reframing thoughts and impulses
Primary Outcome Measure Information:
Title
Parasuicidal behaviour
Time Frame
intermittent
Secondary Outcome Measure Information:
Title
Psychiatric hospitalization
Time Frame
intermittent
Title
Psychiatric symptoms
Time Frame
intermittent
Title
Treatment retention
Time Frame
intermittent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelley F. McMain, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada

12. IPD Sharing Statement

Citations:
Citation
American Psychiatric Association (2001). Diagnostic and Statistical Manual of Mental Disorders. Washington DC: American Psychiatric Association.
Results Reference
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PubMed Identifier
11665545
Citation
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.
Results Reference
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PubMed Identifier
6619404
Citation
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.
Results Reference
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PubMed Identifier
4066162
Citation
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.
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Citation
Gunderson, J.G. (1984) Borderline Personality Disorder. Washington DC: American Psychiatric Press.
Results Reference
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Citation
Linehan,M.M. (1993). Cognitive-Behavorial Treatment of Borderline Personality Disorder. New York: The Guilford Press.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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
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PubMed Identifier
3691077
Citation
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.
Results Reference
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Citation
Scheel,K. The empirical basis of dialectical behavioral therapy: Summary, critique and implications. Clinical Psychology-Science and Practice,2000, 7, 68-86.
Results Reference
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Citation
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
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
22581157
Citation
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.
Results Reference
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PubMed Identifier
19755574
Citation
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. Erratum In: Am J Psychiatry. 2010 Oct;167(10):1283.
Results Reference
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Links:
URL
http://WWW.camh.net
Description
Web page for the Centre for Addiction and Mental Health

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Hope for the Chronically Suicidal Patient

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