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Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: An umbrella trial

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Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: An umbrella trial. / Hutton, Paul; Taylor, Christopher D J; Kelly, James et al.
In: Schizophrenia research, Vol. 282, 31.08.2025, p. 184-197.

Research output: Contribution to Journal/MagazineJournal articlepeer-review

Harvard

Hutton, P, Taylor, CDJ, Kelly, J, Emsley, R, Vikram, A, Alexander, CH, McCann, A, Saddington, D, Eliasson, E, Burke, J, Harper, S, Karatzias, T, Taylor, PJ, Watson, A, Dougall, N, Stavert, J, O'Rourke, S, Glasgow, A, Murphy, R, Palmer, K, Zaidi, N, Bidwell, P, Pritchard, J, Carr, L & Woodrow, A 2025, 'Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: An umbrella trial', Schizophrenia research, vol. 282, pp. 184-197. https://doi.org/10.1016/j.schres.2025.06.018

APA

Hutton, P., Taylor, C. D. J., Kelly, J., Emsley, R., Vikram, A., Alexander, C. H., McCann, A., Saddington, D., Eliasson, E., Burke, J., Harper, S., Karatzias, T., Taylor, P. J., Watson, A., Dougall, N., Stavert, J., O'Rourke, S., Glasgow, A., Murphy, R., ... Woodrow, A. (2025). Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: An umbrella trial. Schizophrenia research, 282, 184-197. Advance online publication. https://doi.org/10.1016/j.schres.2025.06.018

Vancouver

Hutton P, Taylor CDJ, Kelly J, Emsley R, Vikram A, Alexander CH et al. Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: An umbrella trial. Schizophrenia research. 2025 Aug 31;282:184-197. Epub 2025 Jul 3. doi: 10.1016/j.schres.2025.06.018

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Bibtex

@article{ccc2219188a34797954269a9233b0951,
title = "Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: An umbrella trial",
abstract = "INTRODUCTION: Many individuals with schizophrenia-spectrum disorder ('psychosis') lack capacity to make decisions about psychiatric treatment ('incapacity'), however we lack robust evidence from clinical trials on interventions to improve it. To accelerate their development, we tested whether an 'umbrella' trial was feasible. This involved running multiple randomised controlled 'interventionist-causal' trials (IC-RCTs) concurrently. Each tested the effect on incapacity of targeting an individual psychological mechanism.METHODS: We did 3 assessor-blind, multi-site, pilot IC-RCTs. Each compared 6 sessions of psychological therapy for either self-stigma (SS), low self-esteem (SE) or the jumping-to-conclusions (JTC) bias, to 6 sessions of collaborative assessment of the causes of incapacity (control). Adults with psychosis, incapacity and ≥1 target mechanism could participate. Primary outcomes were recruitment feasibility, and data retention on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T).RESULTS: We recruited 57 participants and performed 60 randomisations (3 patients participated in 2 trials); 82 % provided post-treatment data. Standardised mean differences (Hedges' g) for MacCAT-T 'understanding' were g = 0.35 (SS; 95 % CI -0.51, 1.22), g = 0.41 (JTC; -0.55, 1.38) and g = 0.74 (SE; -0.73, 2.21), with positive values favouring treatment. For 'reasoning', they were -0.20 (SS; -1.05, 0.66), 0.79 (JTC; -0.20, 1.79) and 0.79 (SE -0.69, 2.27). For 'appreciation' they were -0.39 (SS; -1.25, 0.48), 1.76 (JTC; 0.62, 2.90) and 0.57 (SE; -0.87, 2.02). Four control participants had 9 serious adverse events between randomisation and post-treatment; two intervention participants had 2.DISCUSSION: An umbrella trial of psychological interventions to improve capacity in psychosis is feasible. A definitive trial is warranted.TRIAL PRE-REGISTRATION: NCT04309435.",
keywords = "Schizophrenia, Supported decision-making, Randomised controlled trial, Psychosis, Patient autonomy, Umbrella trial",
author = "Paul Hutton and Taylor, {Christopher D J} and James Kelly and Richard Emsley and Anvita Vikram and Alexander, {Candy Ho} and Andrea McCann and David Saddington and Emma Eliasson and Joseph Burke and Sean Harper and Thanos Karatzias and Taylor, {Peter J} and Andrew Watson and Nadine Dougall and Jill Stavert and Suzanne O'Rourke and Angela Glasgow and Regina Murphy and Karen Palmer and Nosheen Zaidi and Polly Bidwell and Jemma Pritchard and Lucy Carr and Amanda Woodrow",
year = "2025",
month = jul,
day = "3",
doi = "10.1016/j.schres.2025.06.018",
language = "English",
volume = "282",
pages = "184--197",
journal = "Schizophrenia research",
issn = "1573-2509",

}

RIS

TY - JOUR

T1 - Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: An umbrella trial

AU - Hutton, Paul

AU - Taylor, Christopher D J

AU - Kelly, James

AU - Emsley, Richard

AU - Vikram, Anvita

AU - Alexander, Candy Ho

AU - McCann, Andrea

AU - Saddington, David

AU - Eliasson, Emma

AU - Burke, Joseph

AU - Harper, Sean

AU - Karatzias, Thanos

AU - Taylor, Peter J

AU - Watson, Andrew

AU - Dougall, Nadine

AU - Stavert, Jill

AU - O'Rourke, Suzanne

AU - Glasgow, Angela

AU - Murphy, Regina

AU - Palmer, Karen

AU - Zaidi, Nosheen

AU - Bidwell, Polly

AU - Pritchard, Jemma

AU - Carr, Lucy

AU - Woodrow, Amanda

PY - 2025/7/3

Y1 - 2025/7/3

N2 - INTRODUCTION: Many individuals with schizophrenia-spectrum disorder ('psychosis') lack capacity to make decisions about psychiatric treatment ('incapacity'), however we lack robust evidence from clinical trials on interventions to improve it. To accelerate their development, we tested whether an 'umbrella' trial was feasible. This involved running multiple randomised controlled 'interventionist-causal' trials (IC-RCTs) concurrently. Each tested the effect on incapacity of targeting an individual psychological mechanism.METHODS: We did 3 assessor-blind, multi-site, pilot IC-RCTs. Each compared 6 sessions of psychological therapy for either self-stigma (SS), low self-esteem (SE) or the jumping-to-conclusions (JTC) bias, to 6 sessions of collaborative assessment of the causes of incapacity (control). Adults with psychosis, incapacity and ≥1 target mechanism could participate. Primary outcomes were recruitment feasibility, and data retention on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T).RESULTS: We recruited 57 participants and performed 60 randomisations (3 patients participated in 2 trials); 82 % provided post-treatment data. Standardised mean differences (Hedges' g) for MacCAT-T 'understanding' were g = 0.35 (SS; 95 % CI -0.51, 1.22), g = 0.41 (JTC; -0.55, 1.38) and g = 0.74 (SE; -0.73, 2.21), with positive values favouring treatment. For 'reasoning', they were -0.20 (SS; -1.05, 0.66), 0.79 (JTC; -0.20, 1.79) and 0.79 (SE -0.69, 2.27). For 'appreciation' they were -0.39 (SS; -1.25, 0.48), 1.76 (JTC; 0.62, 2.90) and 0.57 (SE; -0.87, 2.02). Four control participants had 9 serious adverse events between randomisation and post-treatment; two intervention participants had 2.DISCUSSION: An umbrella trial of psychological interventions to improve capacity in psychosis is feasible. A definitive trial is warranted.TRIAL PRE-REGISTRATION: NCT04309435.

AB - INTRODUCTION: Many individuals with schizophrenia-spectrum disorder ('psychosis') lack capacity to make decisions about psychiatric treatment ('incapacity'), however we lack robust evidence from clinical trials on interventions to improve it. To accelerate their development, we tested whether an 'umbrella' trial was feasible. This involved running multiple randomised controlled 'interventionist-causal' trials (IC-RCTs) concurrently. Each tested the effect on incapacity of targeting an individual psychological mechanism.METHODS: We did 3 assessor-blind, multi-site, pilot IC-RCTs. Each compared 6 sessions of psychological therapy for either self-stigma (SS), low self-esteem (SE) or the jumping-to-conclusions (JTC) bias, to 6 sessions of collaborative assessment of the causes of incapacity (control). Adults with psychosis, incapacity and ≥1 target mechanism could participate. Primary outcomes were recruitment feasibility, and data retention on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T).RESULTS: We recruited 57 participants and performed 60 randomisations (3 patients participated in 2 trials); 82 % provided post-treatment data. Standardised mean differences (Hedges' g) for MacCAT-T 'understanding' were g = 0.35 (SS; 95 % CI -0.51, 1.22), g = 0.41 (JTC; -0.55, 1.38) and g = 0.74 (SE; -0.73, 2.21), with positive values favouring treatment. For 'reasoning', they were -0.20 (SS; -1.05, 0.66), 0.79 (JTC; -0.20, 1.79) and 0.79 (SE -0.69, 2.27). For 'appreciation' they were -0.39 (SS; -1.25, 0.48), 1.76 (JTC; 0.62, 2.90) and 0.57 (SE; -0.87, 2.02). Four control participants had 9 serious adverse events between randomisation and post-treatment; two intervention participants had 2.DISCUSSION: An umbrella trial of psychological interventions to improve capacity in psychosis is feasible. A definitive trial is warranted.TRIAL PRE-REGISTRATION: NCT04309435.

KW - Schizophrenia

KW - Supported decision-making

KW - Randomised controlled trial

KW - Psychosis

KW - Patient autonomy

KW - Umbrella trial

U2 - 10.1016/j.schres.2025.06.018

DO - 10.1016/j.schres.2025.06.018

M3 - Journal article

C2 - 40614350

VL - 282

SP - 184

EP - 197

JO - Schizophrenia research

JF - Schizophrenia research

SN - 1573-2509

ER -