Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154154
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2005-09-07
Brief Title:
Hope for the Chronically Suicidal Patient
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Hypotheses1 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
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
Hypotheses1 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIHR 200204MCT-101123 | None | None | None |