Design of an RCT on cost-effectiveness of group schema therapy versus individual schema therapy for patients with cluster-C personality disorder: the QUEST-CLC study protocol (vol 22, 637, 2022)

I.Z. Groot*, A.S.M. Venhuizen, N. Bachrach, S. Walhout, B. de Moor, K. Nikkels, S. Dalmeijer, M. Maarschalkerweerd, J.R. van Aalderen, H. de Lange, R. Wichers, A. Hollander, S.M.A.A. Evers, R.P.P.P. Grasman, A. Arntz

*Corresponding author for this work

Research output: Contribution to journalArticleScientificpeer-review

Abstract

Background
Given the high prevalence of Cluster-C Personality Disorders (PDs) in clinical populations, disease burden, high societal costs and poor prognosis of comorbid disorders, a major gain in health care can be achieved if Cluster-C PDs are adequately treated. The only controlled cost-effectiveness study published so far found Individual Schema Therapy (IST) to be superior to Treatment as Usual (TAU). Group ST (GST) might improve cost-effectiveness as larger numbers can be treated in (>50%) less time compared to IST. However, to date there is no RCT supporting its (cost-) effectiveness. The overall aim of this study is to assess the evidence for GST for Cluster-C PDs and to improve treatment allocation for individual patients. Three main questions are addressed: 1) Is GST for Cluster-C PDs (cost-)effective compared to TAU? 2) Is GST for Cluster-C PDs (cost-) effective compared to IST? 3) Which patient-characteristics predict better response to GST, IST, or TAU?

Methods
In a multicenter RCT, the treatment conditions GST, IST, and TAU are compared in 378 Cluster-C PD patients within 10 sites. GST and IST follow treatment protocols and are completed within 1 year. TAU is the optimal alternative treatment available at the site according to regular procedures. Severity of the Cluster-C PD is the primary outcome, assessed with clinical interviews by independent raters blind for treatment. Functioning and wellbeing are important secondary outcomes. Assessments take place at week 0 (baseline), 17 (mid-GST), 34 (post-GST), 51 (post-booster sessions of GST), and 2 years (FU). Patient characteristics predicting better response to a specific treatment are studied, e.g., childhood trauma, autistic features, and introversion. A tool supporting patients and clinicians in matching treatment to patient will be developed. An economic evaluation investigates the cost-effectiveness and cost-utility from a societal perspective. A process evaluation by qualitative methods explores experiences of participants, loved ones and therapists regarding recovery, quality of life, and improving treatment.

Discussion
This study will determine the (cost-)effectiveness of treatments for Cluster-C PDs regarding treatment type as well as optimal matching of patient to treatment and deliver insight into which aspects help Cluster-C-PD patients recover and create a fulfilling life.
Original languageEnglish
Article number637
Number of pages2
JournalBMC Psychiatry
Volume22
Issue number1
DOIs
Publication statusPublished - 2022

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