DBT for Chronically Self-harming Individuals With BPD: Evaluating the Clinical & Cost Effectiveness of a 6 mo. Treatment

Borderline Personality Disorder Clinical Trial

— FASTER-DBT  

Official title:

Dialectical Behaviour Therapy for Chronically Self-harming Individuals With BPD: Evaluating the Clinical and Cost Effectiveness of a 6-month Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02387736
• Other study ID #: 026/2014
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2015
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Standard one-year dialectical behaviour therapy (DBT), which has four components, is an effective treatment for people with borderline personality disorder. However, such DBT programs are in short supply and costly, resulting in long wait lists. In practice, DBT is often reduced in length or intensity. This study will determine whether shorter DBT treatment is clinically effective and cost-effective. In total, 240 self-harming BPD patients will be randomly assigned to receive either 1 year or 6 months of DBT, with follow-up lasting two years. Rates of suicidal and self-harm behaviours, use of health care and general psychological functioning will be examined.

Description:

Borderline personality disorder (BPD) is a serious and debilitating psychiatric condition characterized by instability in relationships, emotions, identity, and behaviour. Affecting 2-6% of the general population, BPD is associated with high rates of self-harm (both suicide attempts and non-suicidal self-injury), mortality by suicide, and consequent heavy use of public health resources, making it one of the most expensive psychiatric disorders to treat. Psychotherapy is recognized as the first-line treatment for BPD, of which dialectical behaviour therapy (DBT) has demonstrated the strongest empirical support. Although DBT is efficacious for self-harming individuals with BPD, and increasingly available over the past 10 years, demand for DBT exceeds existing resources.

Within the current climate of rising health care costs and limited resources, the length (12 month) and intensive nature (entailing multiple treatment components) of standard DBT are major barriers to its adoption. Subsequently, most DBT programs have lengthy wait lists. Inadequate accessibility of treatment is not specific to Canada; it is a global problem. In clinical practice, DBT is often abbreviated, or clinicians deliver only the components that they believe are most appropriate, despite an evidence base almost entirely consisting of studies of 1 year of DBT. There are no data on the optimal length of treatment.

Therefore, the primary aim of this proposal is to examine the efficacy of an abbreviated course of DBT (including all components of treatment) compared to the evidence-supported 12 months of DBT. Our principal question is: How do the clinical outcomes of 6 months of DBT (DBT-6) compare with the standard 12 months (DBT-12) for the treatment of chronically self-harming individuals with BPD? Assessments will be conducted at pretreatment and at 3-month intervals until 24 months (i.e., 3, 6, 9, 12, 15, 18, 21, and 24 months).

Hypotheses: (1) Patients in the DBT-6 arm will show reductions in the frequency of self-harm across the treatment phase and one-year post treatment follow-up phase no worse than those measured with patients in the DBT-12 arm. (2) Patients who present with high rates of self-harm and impulsive behaviours will have reductions in the frequency of self-harm behaviours that are no worse than those in the DBT-6 arm and the DBT-12 arm, over the course of both the treatment phase and the 1-year post treatment follow-up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Meets DSM-IV criteria for Borderline Personality Disorder.

• Has had at least 2 self-harm episodes (either suicidal or non-suicidal) in the past 5 years, including at least 1 in the past 8 weeks.

• Proficient in English

• Provides informed consent to participate in the study.

• Absence of 8 or more standard weeks of DBT in the past year (individual and group therapy components).

• has had either Ontario Health Insurance Plan (OHIP) coverage or BC Medical Services Plan (MSP) health insurance for 1 year or more

• Absence of a pending criminal court case or charges.

• Has been a resident of Ontario or British Columbia for all of the past 12 months, at least.

• Lives in the Greater Toronto Area/Greater Vancouver Area

Exclusion Criteria:

• Meets the DSM-IV criteria for bipolar disorder I, dementia, or a psychotic disorder other than psychotic disorder NOS

• IQ less than 70

• Chronic or serious physical health problem requiring hospitalization within the next year (e.g., cancer)

• Plans to move to a province other than Ontario or BC in the next 2 years.

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• Dialectical Behaviour Therapy-6 months
Modification of behaviours achieved with reframing thoughts and impulses
• Dialectical Behaviour Therapy-12 months
Modification of behaviours achieved with reframing thoughts and impulses

Locations

Country	Name	City	State
Canada	Simon Fraser University	Burnaby	British Columbia
Canada	Center for Addiction and Mental Health	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Canadian Institutes of Health Research (CIHR), Simon Fraser University

Country where clinical trial is conducted

Canada, 

References & Publications (14)

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders 2013; 5 ed. Washington, DC: American Psychiatric Association Press.

Bateman A, Fonagy P. Health service utilization costs for borderline personality disorder patients treated with psychoanalytically oriented partial hospitalization versus general psychiatric care. Am J Psychiatry. 2003 Jan;160(1):169-71. doi: 10.1176/appi.ajp.160.1.169. — View Citation

Bateman AW. Treating borderline personality disorder in clinical practice. Am J Psychiatry. 2012 Jun;169(6):560-3. doi: 10.1176/appi.ajp.2012.12030341. No abstract available. — View Citation

Black DW, Blum N, Pfohl B, Hale N. Suicidal behavior in borderline personality disorder: prevalence, risk factors, prediction, and prevention. J Pers Disord. 2004 Jun;18(3):226-39. doi: 10.1521/pedi.18.3.226.35445. — View Citation

Comtois, K. A., Elwood, L., Holdcraft, L. C., Smith, W. R., Simpson, T. L. Effectiveness of dialectical behaviour therapy in a community mental health centre. Cognitive And Behavioral Practice 2007; 14(4):406-14.

Grant BF, Chou SP, Goldstein RB, Huang B, Stinson FS, Saha TD, Smith SM, Dawson DA, Pulay AJ, Pickering RP, Ruan WJ. Prevalence, correlates, disability, and comorbidity of DSM-IV borderline personality disorder: results from the Wave 2 National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry. 2008 Apr;69(4):533-45. doi: 10.4088/jcp.v69n0404. — View Citation

Linehan MM, Comtois KA, Murray AM, Brown MZ, Gallop RJ, Heard HL, Korslund KE, Tutek DA, Reynolds SK, Lindenboim N. Two-year randomized controlled trial and follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and borderline personality disorder. Arch Gen Psychiatry. 2006 Jul;63(7):757-66. doi: 10.1001/archpsyc.63.7.757. Erratum In: Arch Gen Psychiatry. 2007 Dec;64(12):1401. — View Citation

Linehan, M.M. Cognitive Behavioural Treatment of Borderline Personality Disorder. New York: Guilford Press; 1993.

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. — View Citation

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. Erratum In: Am J Psychiatry. 2010 Oct;167(10):1283. — View Citation

Skodol AE, Gunderson JG, Pfohl B, Widiger TA, Livesley WJ, Siever LJ. The borderline diagnosis I: psychopathology, comorbidity, and personality structure. Biol Psychiatry. 2002 Jun 15;51(12):936-50. doi: 10.1016/s0006-3223(02)01324-0. — View Citation

Skodol AE, Siever LJ, Livesley WJ, Gunderson JG, Pfohl B, Widiger TA. The borderline diagnosis II: biology, genetics, and clinical course. Biol Psychiatry. 2002 Jun 15;51(12):951-63. doi: 10.1016/s0006-3223(02)01325-2. — View Citation

Soeteman DI, Hakkaart-van Roijen L, Verheul R, Busschbach JJ. The economic burden of personality disorders in mental health care. J Clin Psychiatry. 2008 Feb;69(2):259-65. doi: 10.4088/jcp.v69n0212. — View Citation

Zanarini MC, Frankenburg FR, Hennen J, Silk KR. Mental health service utilization by borderline personality disorder patients and Axis II comparison subjects followed prospectively for 6 years. J Clin Psychiatry. 2004 Jan;65(1):28-36. doi: 10.4088/jcp.v65n0105. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII)	Records details regarding the frequency, topography, intent, medical severity, social context, precipitating and concurrent events, and outcomes of each self-harm (suicidal and non-suicidal) behavior during a three-month target time period.	Administered pre-treatment and every three months until 24 months
Secondary	Changes in health care use as measured by the Treatment History Interview-2 (THI-2)	Records participants use of other treatment resources, e.g. number of Hospitalizations, Emergency Room Visits, Medications, Psychosocial Treatments	Administered pre-treatment and every three months until 24 months
Secondary	Change in general functioning as measured by the Euroqol-5D	Assesses health related quality of life	At pre-treatment and every three months until 24 months
Secondary	Change in BPD symptoms as measured by the Borderline Symptom List-23 (BSL-23)	Assesses presence of specific BPD symptoms	At pre-treatment and every three months over 24 months
Secondary	Change in general psychopathology and symptoms, as measures by the Symptom Checklist 90 Revised (SCL-90R)	Assesses general symptom distress	At pre-treatment and every three months over 24 months
Secondary	Change in anger as measured by the State-Trait Anger Expression Inventory-2 (STAXI-2)	Assesses a subject's experience and expression of anger	At pre-treatment and every three months over 24 months
Secondary	Change in depression as measured by the Beck Depression Inventory-II (BDI-II)	Assesses symptoms of depression	At pre-treatment and every three months over 24 months
Secondary	Changes to interpersonal functioning as measured by the Inventory of Interpersonal Problems-64 (IIP-64)	Assesses dysfunctional patterns in interpersonal interactions	At pre-treatment and every three months over 24 months
Secondary	Changes in the use of DBT coping skills, as measured by the Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL)	Assesses the use of DBT skills	At pre-treatment and every three months over 24 months

External Links

•   The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.