Journal Article

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

Groot, Iuno Z., van Aalderen, Joël R., Maarschalkerweerd, Myrte, Wichers, Renske, Nikkels, Kasper, Dalmeijer, Susanne, Walhout, Simone, Evers, Silvia M. A. A., Venhuizen, Anne-Sophie S. M., Arntz, Arnoud, de Moor, Bregje, Hollander, Agatha Ph, Bachrach, Nathan, Grasman, Raoul P. P. P., de Lange, Hinde

2022

Overview

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. Trial registration Dutch Trial Register: NL9209 . Registered on 28-01-2021,

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Anxiety / Autism / Care and treatment / Children / Clinical trials / Cluster-C personality disorder / Comorbidity / Cost analysis / Cost-Benefit Analysis / Economic evaluation / Funding / Group schema therapy / Group therapy / Humans / Individual schema therapy / Medical research / Medicine / Medicine & Public Health / Methods / Multicenter Studies as Topic / Patients / Personality / Personality disorders / Personality Disorders - therapy / Personalized care / Planning / Psychiatry / Psychotherapy / Psychotherapy, Group - methods / Quality of Life / Randomized controlled trial / Schema Therapy / Sleep / Study Protocol / Testing / Trauma / Treatment Outcome