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

Shelley F McMain, Alexander L Chapman, Janice R Kuo, Tim Guimond, David L Streiner, Katherine L Dixon-Gordon, Wanrudee Isaranuwatchai, Jeffrey S Hoch, Shelley F McMain, Alexander L Chapman, Janice R Kuo, Tim Guimond, David L Streiner, Katherine L Dixon-Gordon, Wanrudee Isaranuwatchai, Jeffrey S Hoch

Abstract

Background: Although Dialectical Behaviour Therapy (DBT) is an evidence-based psychosocial treatment for borderline personality disorder (BPD), the demand for it exceeds available resources. The commonly researched 12-month version of DBT is lengthy; this can pose a barrier to its adoption in many health care settings. Further, there are no data on the optimal length of psychotherapy for BPD. The aim of this study is to examine the clinical and cost-effectiveness of 6 versus 12 months of DBT for chronically suicidal individuals with BPD. A second aim of this study is to determine which patients are as likely to benefit from shorter treatment as from longer treatment.

Methods/design: Powered for non-inferiority testing, this two-site single-blind trial involves the random assignment of 240 patients diagnosed with BPD to 6 or 12 months of standard DBT. The primary outcome is the frequency of suicidal or non-suicidal self-injurious episodes. Secondary outcomes include healthcare utilization, psychiatric and emotional symptoms, general and social functioning, and health status. Cost-effectiveness outcomes will include the cost of providing each treatment as well as health care and societal costs (e.g., missed work days and lost productivity). Assessments are scheduled at pretreatment and at 3-month intervals until 24 months.

Discussion: This is the first study to directly examine the dose-effect of psychotherapy for chronically suicidal individuals diagnosed with BPD. Examining both clinical and cost effectiveness in 6 versus 12 months of DBT will produce answers to the question of how much treatment is good enough. Information from this study will help to guide decisions about the allocation of scarce treatment resources and recommendations about the benefits of briefer treatment.

Trial registration: NCT02387736 . Registered February 20, 2015.

Keywords: Borderline personality disorder; Dialectical behaviour therapy; Randomized controlled trials; Self-injury; Suicide.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval to conduct this study was approved by the research ethics boards at CAMH on May 15, 2014 (#026/2014) and at Simon Fraser University on August 28, 2015 (#2014 s0263).

Prospective participants completed a brief telephone screen and if it appeared that they fulfilled inclusion criteria, they were invited to attend an in-person screen assessment. At this appointment, trained study assessors provided prospective participants with written and verbal information about the study and included time for individuals to ask questions. Prospective participants were then asked to sign the consent form, which was co-signed by the assessor. Consent forms are signed to acknowledge their understanding and agreement to participant in all aspects of the study and the ability to withdraw their consent at any time.

In September 2015, the Principal Investigators (SM, AC) applied for and received an ethical amendment to the original approved application to recruit participants from the existing study to participate in a 2 year genetics sub-project. A separate consent procedure and consent form was developed for this sub-project.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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