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Open Access 01-12-2012 | Study protocol

Design of a multicentered randomized controlled trial on the clinical and cost effectiveness of schema therapy for personality disorders

Authors: Lotte LM Bamelis, Silvia MAA Evers, Arnoud Arntz

Published in: BMC Public Health | Issue 1/2012

Abstract

Background

Despite international guidelines describing psychotherapy as first choice for people with personality disorders (PDs), well-designed research on the effectiveness and cost-effectiveness of psychotherapy for PD is scarce. Schema therapy (ST) is a specific form of psychological treatment that proved to be effective for borderline PD. Randomized controlled studies on the effectiveness of ST for other PDs are lacking. Another not yet tested new specialized treatment is Clarification Oriented Psychotherapy (COP). The aim of this project is to perform an effectiveness study as well as an economic evaluation study (cost effectiveness as well as cost-utility) comparing ST versus COP versus treatment as usual (TAU). In this study, we focus on avoidant, dependent, obsessive-compulsive, paranoid, histrionic and narcissistic PD.

Methods/Design

In a multicentered randomized controlled trial, ST, and COP as an extra experimental condition, are compared to TAU. Minimal 300 patients are recruited in 12 mental health institutes throughout the Netherlands, and receive an extensive screening prior to enrolment in the study. When eligible, they are randomly assigned to one of the intervention groups. An economic evaluation and a qualitative research study on patient and therapist perspectives on ST are embedded in this trial. Outcome assessments (both for clinical effectiveness and economic evaluation) take place at 6,12,18,24 and 36 months after start of treatment. Primary outcome is recovery from PD; secondary measures include general psychopathological complaints, social functioning and quality of life. Data for the cost-effectiveness and cost-utility analyses are collected by using a retrospective cost interview. Information on patient and therapist perspectives is gathered using in-depth interviews and focus groups, and focuses on possible helpful and impeding aspects of ST.

Discussion

This trial is the first to compare ST and COP head-to-head with TAU for people with a cluster C, paranoid, histrionic and/or narcissistic PD. By combining clinical effectiveness data with an economic evaluation and with direct information from primary stakeholders, this trial offers a complete and thorough view on ST as a contribution to the improvement of treatment for this PD patient group.

Trial registration

Netherlands Trial Register (NTR): NTR566

Available only for authorised users

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/12/75/prepub

Title: Design of a multicentered randomized controlled trial on the clinical and cost effectiveness of schema therapy for personality disorders
Authors: Lotte LM Bamelis
Silvia MAA Evers
Arnoud Arntz
Publication date: 01-12-2012
Publisher: BioMed Central
Published in: BMC Public Health / Issue 1/2012
Electronic ISSN: 1471-2458
DOI: https://doi.org/10.1186/1471-2458-12-75

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Springer Medicine

Design of a multicentered randomized controlled trial on the clinical and cost effectiveness of schema therapy for personality disorders

Abstract

Background

Methods/Design

Discussion

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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