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

NCT ID: NCT02387736

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2025-03-31

Brief 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.

Detailed 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.

Conditions

Borderline Personality Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dialectical Behaviour Therapy-6 months

6 months of standard dialectical behaviour therapy treatment.

Group Type: EXPERIMENTAL

Dialectical Behaviour Therapy-6 months

Intervention Type: BEHAVIORAL

Modification of behaviours achieved with reframing thoughts and impulses

Dialectical Behaviour Therapy-12 months

12 months of standard dialectical behaviour therapy treatment

Group Type: ACTIVE_COMPARATOR

Dialectical Behaviour Therapy-12 months

Intervention Type: BEHAVIORAL

Modification of behaviours achieved with reframing thoughts and impulses

Interventions

Dialectical Behaviour Therapy-6 months

Modification of behaviours achieved with reframing thoughts and impulses

Intervention Type: BEHAVIORAL

Dialectical Behaviour Therapy-12 months

Modification of behaviours achieved with reframing thoughts and impulses

Intervention Type: BEHAVIORAL

Other Intervention Names

DBT-6; DBT-12

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Simon Fraser University

OTHER

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Shelley McMain

Head, Borderline Personality Disorder Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shelley McMain, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Centre for Addiction and Mental Health

Locations

Simon Fraser University

Burnaby, British Columbia, Canada

Center for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 18426259 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18363454 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22684591 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12062877 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12062878 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15237043 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 12505818 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14744165 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19755574 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16818865 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22581157 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 33884617 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32368793 (View on PubMed)

McMain SF, Chapman AL, Kuo JR, Guimond T, Streiner DL, Dixon-Gordon KL, Isaranuwatchai W, Hoch JS. The effectiveness of 6 versus 12-months of dialectical behaviour therapy for borderline personality disorder: the feasibility of a shorter treatment and evaluating responses (FASTER) trial protocol. BMC Psychiatry. 2018 Jul 17;18(1):230. doi: 10.1186/s12888-018-1802-z.

Reference Type: DERIVED

PMID: 30016935 (View on PubMed)

Related Links

http://www.camh.ca/en/research

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.

Other Identifiers

026/2014

Identifier Type: -

Identifier Source: org_study_id