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

March 6, 2024 updated by: Shelley McMain, Centre for Addiction and Mental Health

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5A IS6
        • Simon Fraser University
    • Ontario
      • Toronto, Ontario, Canada, M5S 2S1
        • Center for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dialectical Behaviour Therapy-6 months
6 months of standard dialectical behaviour therapy treatment.
Behavioral: Dialectical Behaviour Therapy-6 months
Modification of behaviours achieved with reframing thoughts and impulses
Other Names:
  • DBT-6
Active Comparator: Dialectical Behaviour Therapy-12 months
12 months of standard dialectical behaviour therapy treatment
Behavioral: Dialectical Behaviour Therapy-12 months
Modification of behaviours achieved with reframing thoughts and impulses
Other Names:
  • DBT-12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII)
Time Frame: Administered pre-treatment and every three months until 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in health care use as measured by the Treatment History Interview-2 (THI-2)
Time Frame: Administered pre-treatment and every three months until 24 months
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
Change in general functioning as measured by the Euroqol-5D
Time Frame: At pre-treatment and every three months until 24 months
Assesses health related quality of life
At pre-treatment and every three months until 24 months
Change in BPD symptoms as measured by the Borderline Symptom List-23 (BSL-23)
Time Frame: At pre-treatment and every three months over 24 months
Assesses presence of specific BPD symptoms
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)
Time Frame: At pre-treatment and every three months over 24 months
Assesses general symptom distress
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)
Time Frame: At pre-treatment and every three months over 24 months
Assesses a subject's experience and expression of anger
At pre-treatment and every three months over 24 months
Change in depression as measured by the Beck Depression Inventory-II (BDI-II)
Time Frame: At pre-treatment and every three months over 24 months
Assesses symptoms of depression
At pre-treatment and every three months over 24 months
Changes to interpersonal functioning as measured by the Inventory of Interpersonal Problems-64 (IIP-64)
Time Frame: At pre-treatment and every three months over 24 months
Assesses dysfunctional patterns in interpersonal interactions
At pre-treatment and every three months over 24 months
Changes in the use of DBT coping skills, as measured by the Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL)
Time Frame: At pre-treatment and every three months over 24 months
Assesses the use of DBT skills
At pre-treatment and every three months over 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

Canadian Institutes of Health Research (CIHR)
Simon Fraser University

Investigators

  • Principal Investigator: Shelley McMain, Ph.D, The Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimated)

March 13, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 026/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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