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

• Published in: BMC psychiatry Vol. 22; no. 1; pp. 637 - 18
• Main Authors: Groot, Iuno Z, Venhuizen, Anne-Sophie S M, Bachrach, Nathan, Walhout, Simone, de Moor, Bregje, Nikkels, Kasper, Dalmeijer, Susanne, Maarschalkerweerd, Myrte, van Aalderen, Joël R, de Lange, Hinde, Wichers, Renske, Hollander, Agatha Ph, Evers, Silvia M A A, Grasman, Raoul P P P, Arntz, Arnoud
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 08.10.2022; BioMed Central; BMC
• Subjects: 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; Methods; Multicenter Studies as Topic; Patients; Personality; Personality disorders; Personality Disorders - therapy; Personalized care; Planning; Psychotherapy; Psychotherapy, Group - methods; Quality of Life; Randomized controlled trial; Schema Therapy; Sleep; Study Protocol; Testing; Trauma; Treatment Outcome; Netherlands; Personalized care; Group schema therapy; Cluster-C personality disorder; Randomized controlled trial; Economic evaluation; Individual schema therapy
• ISSN: 1471-244X; 1471-244X
• DOI: 10.1186/s12888-022-04248-9

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