Clinical trials for psychosis treatments routinely fail to recruit enough patients, and the people who do take part often don't reflect the wider patient population. This matters because psychosis—including schizophrenia—is a severe mental health problem, and existing treatments don't help many patients enough. New treatments are needed, but trials are the only reliable way to test them. Patients with psychosis can find it hard to trust researchers due to paranoia or negative voices, motivation to engage is often low, and capacity to consent can fluctuate. NHS staff act as gatekeepers to research, yet their readiness to support recruitment is poorly understood. The result is that trials miss their targets and exclude the very patients who might benefit most. If this research succeeds, it will produce a freely available toolkit for better clinical trial recruitment, co-designed with patients, carers, NHS staff, and researchers. It will also generate a psychometrically strong measure of staff readiness for research, allowing trial teams to evaluate new initiatives. More inclusive and effective recruitment would mean fairer access to trials, more efficient use of research funding, and faster, more reliable learning about which treatments actually work for psychosis.
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Background Psychosis - comprising conditions such as schizophrenia - is a severe mental health problem. There are 220,000 patients with schizophrenia attending NHS mental healthcare services in England and Wales. Each year there are about ten thousand hospital admissions for psychosis. The annual NHS costs for these conditions was estimated to be £2.4 billion in 2014. For many patients, existing treatments do not help enough. New treatments are needed and clinical trials are the gold standard method of evaluation. Recruitment into clinical trials is well-known to be challenging; this is amplified for severe mental health conditions. For example, patients with psychosis can find trusting researchers difficult due to paranoia or negative voices, motivation to engage in new activities can be very low, and capacity to consent and cognitive skills can fluctuate. Furthermore, patients who find it harder to access services miss out on opportunities to participate in research. The consequence is that trial recruitment targets are often not met and participants are often unrepresentative of the patient population. Research is needed to improve recruitment into clinicals trials of treatments for psychosis. Aim and objectives The overall aim is to improve the quality and efficiency of clinical trials for psychosis. The objectives are to use a mixed methods research approach to: Develop a better understanding of effective and inclusive recruitment of patients into clinical trials for psychosis; Produce a psychometrically strong measure of clinical staff readiness for research that can be used to evaluate new initiatives; Co-produce a toolkit for better clinical trial recruitment. Methods Phase 1: Developing a multi-perspective understanding of the factors affecting recruitment rates and participant diversity into clinical trials testing treatments for psychosis Study 1: Mixed methods systematic review The review will identify extant factors affecting recruitment into clinical trials for psychosis. Study 2: Stakeholder qualitative interviews Semi-structured interviews will provide a detailed understanding from the perspectives of key stakeholders of factors affecting recruitment. Participants will be patients with psychosis (n=15), carers of patients with psychosis (n=10), NHS secondary care mental health staff (n=10), GPs (n=10), and researchers (n=10), with maximum diversity sought. Interviews will be analysed using reflective thematic analysis. Phase 2: Measurement of NHS staff readiness NHS staff are the key gatekeepers for clinical research on psychosis. A 'readiness for research questionnaire' for NHS clinical staff will be developed using classical test theory. The psychometric evaluation will be with 500 NHS staff. Phase 3: Co-production of a toolkit Three workshops attended by 20-30 key stakeholders will be held to ensure that the toolkit reflects the needs of patients, carers, NHS staff, and researchers. Dissemination and impact The toolkit will be made freely available online. There will be dissemination to trial funders and clinical trials units involved in psychosis research. If participation in clinical trials testing treatments for psychosis is more inclusive and effective, equity of access will be improved, resource use will be more efficient, and better learning about new treatments will be made.
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