Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
180 participants
INTERVENTIONAL
2002-10-31
2009-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
General Psychiatric Management
General Psychiatric Management
General Psychiatric Management (GPM) condition consisting of a structured algorithmic medication intervention plus psychosocial counseling.
2
Dialectal Behaviour Therapy
Dialectical Behaviour Therapy
Modification of behaviours achieved with reframing thoughts and impulses
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Unity Health Toronto
OTHER
Centre for Addiction and Mental Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shelley McMain
Head, Borderline Personality Disorder Clinic
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shelley F. McMain, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St Michael's Hospital
Toronto, Ontario, Canada
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1037//0021-843x.92.3.263. No abstract available.
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.
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. doi: 10.1016/0010-440x(87)90019-8. 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
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Web page for the Centre for Addiction and Mental Health
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIHR: #200204MCT-101123
Identifier Type: -
Identifier Source: secondary_id
CIHR: #200204MCT-101123
Identifier Type: -
Identifier Source: org_study_id