Hope for the Chronically Suicidal Patient

Borderline Personality Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154154
• Other study ID #: CIHR: #200204MCT-101123
• Secondary ID: CIHR: #200204MCT
• Status: Completed
• Phase: N/A
• First received: September 7, 2005
• Last updated: December 11, 2012
• Start date: October 2002
• Est. completion date: April 2009

Study information

• Verified date: December 2012
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2009
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• General Psychiatric Management
General Psychiatric Management (GPM) condition consisting of a structured algorithmic medication intervention plus psychosocial counseling.
• Dialectical Behaviour Therapy
Modification of behaviours achieved with reframing thoughts and impulses

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
Canada	St Michael's Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Canadian Institutes of Health Research (CIHR), St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. — View 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. — View 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. — View Citation

Gunderson, J.G. (1984) Borderline Personality Disorder. Washington DC: American Psychiatric 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,M.M. (1993). Cognitive-Behavorial Treatment of Borderline Personality Disorder. New York: The Guilford Press.

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. — View Citation

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

Wilson PT, Spitzer RL. Major changes in psychiatric nomenclature. Reconciling existing psychiatric medical records with the new American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders. Hosp Community Psychiatry. 1968 Jun;19(6):169-74. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parasuicidal behaviour		intermittent	Yes
Secondary	Psychiatric hospitalization		intermittent	No
Secondary	Psychiatric symptoms		intermittent	No
Secondary	Treatment retention		intermittent	No

External Links

•   Web page for the Centre for Addiction and Mental Health