NCT02387736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

February 20, 2015

Last Update Submit

March 25, 2026

Conditions

Keywords

BPDDBTDialectical Behaviour TherapyBorderline Personality DisorderSuicideNon-suicidal self injuryNSSIRandomized Control trialstreatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Changes in health care use as measured by the Treatment History Interview-2 (THI-2)

    Administered pre-treatment and every three months until 24 months

  • Change in general functioning as measured by the Euroqol-5D

    At pre-treatment and every three months until 24 months

  • Change in BPD symptoms as measured by the Borderline Symptom List-23 (BSL-23)

    At pre-treatment and every three months over 24 months

  • Change in general psychopathology and symptoms, as measures by the Symptom Checklist 90 Revised (SCL-90R)

    At pre-treatment and every three months over 24 months

  • Change in anger as measured by the State-Trait Anger Expression Inventory-2 (STAXI-2)

    At pre-treatment and every three months over 24 months

  • +3 more secondary outcomes

Study Arms (2)

Dialectical Behaviour Therapy-6 months

EXPERIMENTAL

6 months of standard dialectical behaviour therapy treatment.

Behavioral: Dialectical Behaviour Therapy-6 months

Dialectical Behaviour Therapy-12 months

ACTIVE COMPARATOR

12 months of standard dialectical behaviour therapy treatment

Behavioral: Dialectical Behaviour Therapy-12 months

Interventions

Modification of behaviours achieved with reframing thoughts and impulses

Also known as: DBT-12
Dialectical Behaviour Therapy-12 months

Modification of behaviours achieved with reframing thoughts and impulses

Also known as: DBT-6
Dialectical Behaviour Therapy-6 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Simon Fraser University

Burnaby, British Columbia, V5A IS6, Canada

Location

Center for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (18)

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

    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.

    PMID: 18426259BACKGROUND
  • 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.

    PMID: 18363454BACKGROUND
  • 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.

    PMID: 22684591BACKGROUND
  • 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.

    PMID: 12062877BACKGROUND
  • 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.

    PMID: 12062878BACKGROUND
  • 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.

    PMID: 15237043BACKGROUND
  • 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.

    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.

    PMID: 12505818BACKGROUND
  • 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.

    PMID: 14744165BACKGROUND
  • 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.

    PMID: 19755574BACKGROUND
  • 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.

    PMID: 16818865BACKGROUND
  • 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.

    PMID: 22581157BACKGROUND
  • Linehan, M.M. Cognitive Behavioural Treatment of Borderline Personality Disorder. New York: Guilford Press; 1993.

    BACKGROUND
  • Christensen KE, McMain S, Chapman A, Kuo JR. An examination of the role of PTSD and childhood trauma on treatment outcomes for individuals with borderline personality disorder in dialectical behavior therapy. Borderline Personal Disord Emot Dysregul. 2025 Nov 12;12(1):47. doi: 10.1186/s40479-025-00322-2.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Borderline Personality DisorderSuicideSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Shelley McMain, Ph.D

    The Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Borderline Personality Disorder Clinic

Study Record Dates

First Submitted

February 20, 2015

First Posted

March 13, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations