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
|Condition or disease||Intervention/treatment||Phase|
|Borderline Personality Disorder||Behavioral: General Psychiatric Management Behavioral: Dialectical Behaviour Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
Dialectal Behaviour Therapy
Behavioral: Dialectical Behaviour Therapy
Modification of behaviours achieved with reframing thoughts and impulses
- Parasuicidal behaviour [ Time Frame: intermittent ]
- Psychiatric hospitalization [ Time Frame: intermittent ]
- Psychiatric symptoms [ Time Frame: intermittent ]
- Treatment retention [ Time Frame: intermittent ]
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
|St Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5S 2S1|
|Principal Investigator:||Shelley F. McMain, PhD||Centre for Addiction and Mental Health|