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Those affected may experience a range of distressing symptoms, from hallucinations, delusions and conceptual disorganisation to reduced motivation, anhedonia and cognitive impairment. Pre-registered on 16 March 2020.Īpproximately 9–10 people per 1000 will be diagnosed with a schizophrenia-spectrum disorder (‘psychosis’) at some point in their lives. 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. It will produce the first 3 single-blind randomised controlled trials of psychological interventions to support treatment decision-making in schizophrenia-spectrum disorder.
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#Deliberate impression management trial
This will be the first Umbrella trial in mental healthcare. 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. 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. 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). They will be allocated to one of three randomised controlled trials, depending on which mechanism(s) they have. 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). 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). Each is highly prevalent in psychosis, responsive to psychological intervention, and hypothesised to contribute to impaired capacity. We selected three mechanisms to test: ‘self-stigma’, low self-esteem and the ‘jumping to conclusions’ bias. 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. 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 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.
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This is partly because effective and safe methods to do so are lacking. Few will be helped to regain it before these interventions proceed. 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’).
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