TY - JOUR

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

T2 - a study protocol for a multi-site, assessor-blinded, pilot Umbrella trial (the DEC:IDES trial)

AU - Hutton, Paul

AU - Kelly, James

AU - Taylor, Christopher D. J.

AU - Williams, Brian

AU - Emsley, Richard

AU - Alexander, Candy Ho

AU - Vikram, Anvita

AU - Saddington, David

AU - McCann, Andrea

AU - Burke, Joseph

AU - Eliasson, Emma

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 - 2023/7/8

Y1 - 2023/7/8

N2 - Background: A high proportion of patients diagnosed with schizophrenia-spectrum disorders will at some point in their lives be assessed as not having the capacity to make their own decisions about pharmacological treatment or inpatient care (‘capacity’). Few will be helped to regain it before these interventions proceed. This is partly because effective and safe methods to do so are lacking. Our aim is to accelerate their development by testing, for the first time in mental healthcare, the feasibility, acceptability and safety of running an ‘Umbrella’ trial. This involves running, concurrently and under one multi-site infrastructure, multiple assessor-blind randomised controlled trials, each of which is designed to examine the effect on capacity of improving a single psychological mechanism (‘mechanism’). Our primary objectives are to demonstrate feasibility of (i) recruitment and (ii) data retention on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T; planned primary outcome for a future trial) at end-of-treatment. We selected three mechanisms to test: ‘self-stigma’, low self-esteem and the ‘jumping to conclusions’ bias. Each is highly prevalent in psychosis, responsive to psychological intervention, and hypothesised to contribute to impaired capacity. Methods: Sixty participants with schizophrenia-spectrum diagnoses, impaired capacity and one or more mechanism(s) will be recruited from outpatient and inpatient mental health services in three UK sites (Lothian, Scotland; Lancashire and Pennine; North West England). Those lacking capacity to consent to research could take part if the key criteria were met, including either proxy consent (Scotland) or favourable Consultee advice (England). They will be allocated to one of three randomised controlled trials, depending on which mechanism(s) they have. They will then be randomised to receive, over an 8-week period and in addition to treatment as usual (TAU), 6 sessions of either a psychological intervention which targets the mechanism, or 6 sessions of assessment of the causes of their incapacity (control condition). Participants are assessed at 0 (baseline), 8 (end-of-treatment) and 24 (follow-up) weeks post-randomisation using measures of capacity (MacCAT-T), mechanism, adverse events, psychotic symptoms, subjective recovery, quality of life, service use, anxiety, core schemata and depression. Two nested qualitative studies will be conducted; one to understand participant and clinician experiences and one to investigate the validity of MacCAT-T appreciation ratings. Discussion: This will be the first Umbrella trial in mental healthcare. It will produce the first 3 single-blind randomised controlled trials of psychological interventions to support treatment decision-making in schizophrenia-spectrum disorder. Demonstrating feasibility will have significant implications not only for those seeking to support capacity in psychosis, but also for those who wish to accelerate the development of psychological interventions for other conditions. Trial registration: ClinicalTrials.gov NCT04309435. Pre-registered on 16 March 2020.

AB - Background: A high proportion of patients diagnosed with schizophrenia-spectrum disorders will at some point in their lives be assessed as not having the capacity to make their own decisions about pharmacological treatment or inpatient care (‘capacity’). Few will be helped to regain it before these interventions proceed. This is partly because effective and safe methods to do so are lacking. Our aim is to accelerate their development by testing, for the first time in mental healthcare, the feasibility, acceptability and safety of running an ‘Umbrella’ trial. This involves running, concurrently and under one multi-site infrastructure, multiple assessor-blind randomised controlled trials, each of which is designed to examine the effect on capacity of improving a single psychological mechanism (‘mechanism’). Our primary objectives are to demonstrate feasibility of (i) recruitment and (ii) data retention on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T; planned primary outcome for a future trial) at end-of-treatment. We selected three mechanisms to test: ‘self-stigma’, low self-esteem and the ‘jumping to conclusions’ bias. Each is highly prevalent in psychosis, responsive to psychological intervention, and hypothesised to contribute to impaired capacity. Methods: Sixty participants with schizophrenia-spectrum diagnoses, impaired capacity and one or more mechanism(s) will be recruited from outpatient and inpatient mental health services in three UK sites (Lothian, Scotland; Lancashire and Pennine; North West England). Those lacking capacity to consent to research could take part if the key criteria were met, including either proxy consent (Scotland) or favourable Consultee advice (England). They will be allocated to one of three randomised controlled trials, depending on which mechanism(s) they have. They will then be randomised to receive, over an 8-week period and in addition to treatment as usual (TAU), 6 sessions of either a psychological intervention which targets the mechanism, or 6 sessions of assessment of the causes of their incapacity (control condition). Participants are assessed at 0 (baseline), 8 (end-of-treatment) and 24 (follow-up) weeks post-randomisation using measures of capacity (MacCAT-T), mechanism, adverse events, psychotic symptoms, subjective recovery, quality of life, service use, anxiety, core schemata and depression. Two nested qualitative studies will be conducted; one to understand participant and clinician experiences and one to investigate the validity of MacCAT-T appreciation ratings. Discussion: This will be the first Umbrella trial in mental healthcare. It will produce the first 3 single-blind randomised controlled trials of psychological interventions to support treatment decision-making in schizophrenia-spectrum disorder. Demonstrating feasibility will have significant implications not only for those seeking to support capacity in psychosis, but also for those who wish to accelerate the development of psychological interventions for other conditions. Trial registration: ClinicalTrials.gov NCT04309435. Pre-registered on 16 March 2020.

KW - Umbrella trial

KW - Randomised controlled trial

KW - CBT

KW - Patient autonomy

KW - MCT

KW - Schizophrenia

KW - Decision-making capacity

KW - Supported decision-making

U2 - 10.1186/s40814-023-01323-0

DO - 10.1186/s40814-023-01323-0

M3 - Journal article

VL - 9

JO - Pilot and Feasibility Studies

JF - Pilot and Feasibility Studies

SN - 2055-5784

IS - 1

M1 - 117

ER -