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Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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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 -