Day hospital Mentalization-based treatment versus intensive outpatient Mentalization-based treatment for patients with severe borderline personality disorder: protocol of a multicentre randomized clinical trial.
BACKGROUND
Borderline personality disorder (BPD) is associated with a high socioeconomic burden. Although a number of evidence-based treatments for BPD are currently available, they are not widely disseminated; furthermore, there is a need for more research concerning their efficacy and cost-effectiveness. Such knowledge promises to lead to more efficient use of resources, which will facilitate the effective dissemination of these costly treatments. This study focuses on the efficacy and cost-effectiveness of Mentalization-Based Treatment (MBT), a manualized treatment for patients with BPD. Studies to date have either investigated MBT in a day hospitalization setting (MBT-DH) or MBT offered in an intensive outpatient setting (MBT-IOP). No trial has compared the efficacy and cost-effectiveness of these MBT programmes. As both interventions differ considerably in terms of intensity of treatment, and thus potentially in terms of efficacy and cost-effectiveness, there is a need for comparative trials. This study therefore sets out to investigate the efficacy and cost-effectiveness of MBT-DH versus MBT-IOP in patients with BPD. A secondary aim is to investigate the association between baseline measures and outcome, which might improve treatment selection and thus optimize efficacy and cost-effectiveness.


METHODS
A multicentre randomized controlled trial comparing MBT-DH versus MBT-IOP in severe BPD patients. Patients are screened for BPD using the Structured Clinical Interview for DSM-IV Axis II Personality Disorders, and are assessed before randomization, at the start of treatment and 6, 12, 18, 24, 30 and 36 months after the start of treatment. Patients who refuse to participate will be offered care as usual in the same treatment centre. The primary outcome measure is symptom severity as measured by the Brief Symptom Inventory. Secondary outcome measures include parasuicidal behaviour, depression, substance use, social, interpersonal, and personality functioning, attachment, mentalizing capacities, and quality of life. All analyses will be conducted based on the intention-to-treat principle. Cost-effectiveness will be calculated based on costs per quality-adjusted life-year.


CONCLUSIONS
This multisite randomized trial will provide data to refine criteria for treatment selection for severe BPD patients and promises to optimize (cost-)effectiveness of the treatment of BPD patients.


BACKGROUND
NTR2292 . Registered 16 April 2010.
Viersprong Institute for Studies on Personality Disorders (VISPD), Halsteren, the Netherlands. annelies.laurenssen@deviersprong.nl.|Arkin, Amsterdam, the Netherlands. annelies.laurenssen@deviersprong.nl.
Elisabeth M P
EM
Laurenssen
Viersprong Institute for Studies on Personality Disorders (VISPD), Halsteren, the Netherlands. maaike.smits@deviersprong.nl.
Maaike L
ML
Smits
Viersprong Institute for Studies on Personality Disorders (VISPD), Halsteren, the Netherlands. dawn.bales@deviersprong.nl.
Dawn L
DL
Bales
Viersprong Institute for Studies on Personality Disorders (VISPD), Halsteren, the Netherlands. dineke.feenstra@deviersprong.nl.|Department of Psychiatry, section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, the Netherlands. dineke.feenstra@deviersprong.nl.
Dine J
DJ
Feenstra
Viersprong Institute for Studies on Personality Disorders (VISPD), Halsteren, the Netherlands. h.vaneeren1@erasmusmc.nl.|Department of Psychiatry, section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, the Netherlands. h.vaneeren1@erasmusmc.nl.
Hester V
HV
Eeren
Department of Psychiatry, Zaanstad Medical Centre (ZMC), Amsterdam, the Netherlands. noom.m@zaansmc.nl.
Marc J
MJ
Noom
NPI specialist in personality problems, Amsterdam, the Netherlands. maartje.koster@npsai.nl.
Maartje A
MA
Köster
Lentis, Groningen, the Netherlands. z.a.lucas@groningen.psyq.nl.
Zwaan
Z
Lucas
Viersprong Institute for Studies on Personality Disorders (VISPD), Halsteren, the Netherlands. r.timman@erasmusmc.nl.|Department of Psychiatry, section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, the Netherlands. r.timman@erasmusmc.nl.
Reinier
R
Timman
Arkin, Amsterdam, the Netherlands. jack.dekker@arkin.nl.|Department of Clinical Psychology, VU University Amsterdam, Amsterdam, the Netherlands. jack.dekker@arkin.nl.
Jack J M
JJ
Dekker
Faculty of Psychology and Educational Sciences, University of Leuven, Leuven, Belgium. patrick.luyten@ppw.kuleuven.be.|Research Department of Clinical, Educational and Health Psychology, University College London, London, UK. patrick.luyten@ppw.kuleuven.be.
Patrick
P
Luyten
Viersprong Institute for Studies on Personality Disorders (VISPD), Halsteren, the Netherlands. jan.busschbach@deviersprong.nl.|Department of Psychiatry, section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, the Netherlands. jan.busschbach@deviersprong.nl.
Jan J V
JJ
Busschbach
De Viersprong, Halsteren, the Netherlands. roel.verheul@deviersprong.nl.
Roel
R
Verheul
D000553:Ambulatory Care / Q000191:economics / Q000379:methods*; D001883:Borderline Personality Disorder / Q000191:economics / Q000523:psychology / Q000628:therapy*; D003362:Cost-Benefit Analysis; D005260:Female; D006760:Hospitalization / Q000191:economics; D006801:Humans; D008297:Male; D010045:Outpatients / Q000523:psychology; D011788:Quality of Life / Q000523:psychology; D012720:Severity of Illness Index; D056345:Theory of Mind; D016896:Treatment Outcome