Effectiveness of step-down versus outpatient dialectical behaviour therapy for patients with severe levels of borderline personality disorder: a pragmatic randomized controlled trial

Roland Sinnaeve, Louisa M C van den Bosch, Leona Hakkaart-van Roijen, Kristof Vansteelandt, Roland Sinnaeve, Louisa M C van den Bosch, Leona Hakkaart-van Roijen, Kristof Vansteelandt

Abstract

Background: Step-down dialectical behaviour therapy (DBT) is a treatment consisting of 3 months of residential DBT plus 6 months of outpatient DBT. The program was specifically developed for people suffering from severe borderline personality disorder (BPD). The present study examines the effectiveness and cost-effectiveness of step-down DBT compared to 12 months of regular, outpatient DBT.

Methods: Eighty-four participants reporting high levels of BPD-symptoms (mean age 26 years, 95% female) were randomly assigned to step-down versus standard DBT. Measurements were conducted at baseline and after 3, 6, 9 and 12 months. The Lifetime Parasuicide Count and BPD Severity Index (BPDSI) were used to assess suicidal behaviour, non-suicidal self-injury (NSSI) and borderline severity. Costs per Quality Adjusted Life Year (QALY) were calculated using data from the EQ-5D-3L and the Treatment Inventory Cost in Psychiatric Patients (TIC-P).

Results: In step-down DBT, 95% of patients started the program, compared to 45% of patients in outpatient DBT. The probability of suicidal behaviour did not change significantly over 12 months. The probability of NSSI decreased significantly in step-down DBT, but not in outpatient DBT. BPDSI decreased significantly in both groups, with the improvement leveling off at the end of treatment. While step-down DBT was more effective in increasing quality of life, it also cost significantly more. The extra costs per gained QALY exceeded the €80,000 threshold that is considered acceptable for severely ill patients in the Netherlands.

Conclusions: A pragmatic randomized controlled trial in the Netherlands showed that 9 months of step-down DBT is an effective treatment for people suffering from severe levels of BPD. However, step-down DBT is not more effective than 12 months of outpatient DBT, nor is it more cost-effective. These findings should be considered tentative because of high noncompliance with the treatment assignment in outpatient DBT. Furthermore, the long-term effectiveness of step-down DBT, and moderators of treatment response, remain to be evaluated.

Trial registration: www.clinicaltrials.govNCT01904227. Registered 22 July 2013 (retrospectively registered).

Keywords: Borderline personality disorder; Cost effectiveness; Dialectical behaviour therapy; Randomized controlled trial; Residential treatment; Self-injurious behaviour; Suicide.

Conflict of interest statement

This study was approved by the Medical Ethics Committee of the Leiden University Medical Center (P11.012), the Institutional Scientific Board of Rivierduinen and the boards of the participating sites. All participants gave written informed consent.Written informed consent was obtained from the participant for publication of their individual details in this manuscript. The consent form is held by the authors’ institution and is available for review by the Editor-in-Chief.L.M.C.B. is shareholder of Dialexis, the training institute for Dialectical Behaviour Therapy (DBT) in the Netherlands. R.S. works for Dialexis as an instructor. The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT flowchart pragmatic RCT step-down versus outpatient DBT. ‘Received the allocated intervention’ = Number of participants that attended at least one skills training or at least one individual therapy session after they signed a therapist-client agreement (referred to as ‘starters’ in the text). ‘Lost to follow up’= Number of participants that received the allocated intervention but did not complete a 12 month assessment. ‘Discontinued intervention’ = Number of participants that received the allocated intervention but dropped out before it was completely finished. In DBT, ‘dropout’ means that a participant missed four individual therapy or four weekly skills training session in a row. ‘Analyzed’ = Number of participants whose data were used to estimate statistical models for primary outcome variables
Fig. 2
Fig. 2
Estimated Borderline Personality Symptom Index score with time, condition and time x condition as predictors
Fig. 3
Fig. 3
Cost-effectiveness plane step-down DBT versus outpatient DBT. The Y-axis represents additional effects. The X-axis represents additional costs

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