Borderline Personality DisorderNCT00154154
Hope for the Chronically Suicidal Patient
A study testing General Psychiatric Management and Dialectical Behaviour Therapy in people with Borderline Personality Disorder, run by Centre for Addiction and Mental Health at 2 sites in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- General Psychiatric Management and Dialectical Behaviour Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2002to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St Michael's Hospital
Toronto, Ontario, M5B 1W8
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1
About this study
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
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.
Read the 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- General Psychiatric Management, Dialectical Behaviour Therapy
- Keywords
- borderline personality disorder, BPD, treatment, dialectical behavior therapy, DBT, general Psychiatric management, GPM, suicide, parasuicide, randomized control trials
- Medical subject headings
- Borderline Personality Disorder, Suicide, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Psychiatric ManagementBehavioural
General Psychiatric Management (GPM) condition consisting of a structured algorithmic medication intervention plus psychosocial counseling.
Dialectical Behaviour TherapyBehavioural
Modification of behaviours achieved with reframing thoughts and impulses
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | General Psychiatric Management Receives: Behavioral: General Psychiatric Management |
| 2 | Experimental | Dialectal Behaviour Therapy Receives: Behavioral: Dialectical Behaviour Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasuicidal behaviour
Measured: intermittent
Secondary outcomes (3)
Psychiatric hospitalization
Measured: intermittent
Psychiatric symptoms
Measured: intermittent
Treatment retention
Measured: intermittent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionJun 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Unity Health Toronto
- Responsible party
- Principal investigator, Shelley McMain, Centre for Addiction and Mental Health
- Investigators
- Shelley F. McMain, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154154
- Sponsor's protocol ID
- CIHR: #200204MCT-101123
- Other IDs
- CIHR: #200204MCT-101123
- Status last verified
- Dec 2012
- First submitted
- 7 Sep 2005
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11665545Clarkin 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.
PubMed 6619404Cowdry 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.
PubMed 4066162Gunderson, 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.
PubMed 3691077Scheel,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
Tennenhouse R, Ruocco AC, McMain SF, Sonley A. Suicidal and Self-Harming Behaviors in Patients With Borderline Personality Disorder With and Without Eating Disorders. J Pers Disord. 2025 Feb;39(1):48-60. doi: 10.1521/pedi.2025.39.1.48.
PubMed 40014392Witt 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.
PubMed 33884617Storebo 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.
PubMed 32368793
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00154154
- Acronym / sponsor ID
- CIHR: #200204MCT-101123
- Conditions
- Borderline Personality Disorder
- Keywords
- borderline personality disorder, BPD, treatment, dialectical behavior therapy, DBT, general Psychiatric management, GPM, suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Unity Health Toronto
- Study start
- Oct 2002
- Primary completion
- Jun 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: General Psychiatric ManagementGeneral Psychiatric Management |
| 2 | Experimental | Behavioral: Dialectical Behaviour TherapyDialectal Behaviour Therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Psychiatric ManagementGeneral Psychiatric Management (GPM) condition consisting of a structured algorithmic medication intervention plus psychosocial counseling. | Behavioural | A |
| Dialectical Behaviour TherapyModification of behaviours achieved with reframing thoughts and impulses | Behavioural | 2 |
Primary outcome
Parasuicidal behaviour
Time frame: intermittent
3 secondary outcomes
Psychiatric hospitalization
Time frame: intermittent
Psychiatric symptoms
Time frame: intermittent
Treatment retention
Time frame: intermittent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
- BackgroundAmerican Psychiatric Association (2001). Diagnostic and Statistical Manual of Mental Disorders. Washington DC: American Psychiatric Association.
- Background: PubMed 11665545American 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.
- Background: PubMed 6619404Clarkin 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.
- Background: PubMed 4066162Cowdry 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.
- BackgroundGunderson, J.G. (1984) Borderline Personality Disorder. Washington DC: American Psychiatric Press.
- BackgroundLinehan,M.M. (1993). Cognitive-Behavorial Treatment of Borderline Personality Disorder. New York: The Guilford Press.
- BackgroundLinehan, 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.
- BackgroundLinehan,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.
- BackgroundMoscicki, 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
- Background: PubMed 3691077Paris 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.
- BackgroundScheel,K. The empirical basis of dialectical behavioral therapy: Summary, critique and implications. Clinical Psychology-Science and Practice,2000, 7, 68-86.
- BackgroundStone, 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
- Web page for the Centre for Addiction and Mental HealthLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelley F. McMain, PhD principal investigator
Centre for Addiction and Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Psychiatric Management and Dialectical Behaviour Therapy in people with Borderline Personality Disorder, run by Centre for Addiction and Mental Health at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasuicidal behaviour (time frame: intermittent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00154154, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.