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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,I.Z. Venhuizen,A.S.M. Bachrach,N. Walhout,S. de Moor,B. Nikkels,K. Dalmeijer,S. Maarschalkerweerd,M. van Aalderen,J.R. de Lange,H.
Groot,I.Z.
Venhuizen,A.S.M.
Bachrach,N.
Walhout,S.
de Moor,B.
Nikkels,K.
Dalmeijer,S.
Maarschalkerweerd,M.
van Aalderen,J.R.
de Lange,H.
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 (postbooster sessions of GST), and 2 years (FU). Patient characteristics predicting better response to a specifc 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 costutility 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 forCluster-C PDs regarding treatment type as well as optimal matching of patientto treatment and deliver insight into which aspects help Cluster-C-PD patientsrecover and create a fulfilling life. Trial registration Dutch Trial Register: NL9209. Registered on 28-01-2021,
Description
Date
2022
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Publisher
Research Projects
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Keywords
AUTISM-SPECTRUM QUOTIENT, CONTROLLED-TRIAL, Cluster-C personality disorder, Economic evaluation, Group schema therapy, Individual schema therapy, LIFE, MENTAL-HEALTH, MULTICENTER, PREVALENCE, PSYCHOTHERAPY, Personalized care, Randomized controlled trial, VERSION
Citation
Groot, I Z, Venhuizen, A S M, Bachrach, N, Walhout, S, de Moor, B, Nikkels, K, Dalmeijer, S, Maarschalkerweerd, M, van Aalderen, J R, de Lange, H, Wichers, R, Hollander, A P, Evers, S M A A, Grasman, R P P P & Arntz, A 2022, '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', BMC Psychiatry, vol. 22, 637. https://doi.org/10.1186/s12888-022-04248-9