Sedation from Antipsychotics (SoFA)

Scientific abstract Background Psychosis is a serious mental illness which in most cases requires long-term treatment with antipsychotic medications. However, these medications have problematic side effects of which the most common is sedation (excessive sleep and sleepiness), affecting around 40% of patients. Patients rate sedation as amongst the most significant side effects from their medication. Problematic sedation affects patients' day to day activities, stops patients re-engaging with employment, affects their physical health, and makes patients less likely to continue taking their medication. Yet sedation is often overlooked, in part due to lack of standardised assessment to identify problematic sedation, alongside understandable reluctance from patients and clinicians to alter medications due to fear of psychosis relapse. However, it is plausible that there are psychological and behavioural approaches that would improve sedation. To develop these interventions a systematic programme of research is required to understand the experience of sedation, measure its impact, and model its interaction with other factors. Aims and Objectives The Sedation from Antipsychotics (SoFA) project aims to advance our understanding of sedation from antipsychotics, with the aim of informing future intervention development. Objective 1: Establish a Lived Experience Advisory Panel (LEAP) and Multidisciplinary Expertise Advisory Panel (MEAP) to guide the research. Objective 2: Use patient interviews and a meta-synthesis to build understanding of sedation. Objective 3: Design and iteratively develop a patient-reported sedation from antipsychotics questionnaire. Objective 4: Validate patient-reported sedation questionnaire for use in clinical practice. Objective 5: Report on prevalence of sedation, relationship with clinical and demographic variables, and impacts on patient functioning. Objective 6: Apply causal modelling to test psychological and behavioural maintaining factors of sedation to inform intervention development. Methods The objectives will be achieved via three work packages alongside stakeholder engagement (LEAP and MEAP) and dissemination via a dedicated project website and social media output alongside peer reviewed publications. WP1: Understanding sedation Study 1: Meta-synthesis of existing research and clinical guidance Study 2: Qualitative interviews to develop patient perspective WP2: Measuring sedation Study 3: Development and iteration of sedation from antipsychotics questionnaire (based on cognitive interviewing approach) Study 4: Validation of sedation questionnaire (including test-retest and behavioural monitoring subsamples) WP3: Modelling sedation Study 5: Prevalence of sedation and relationship with clinical, demographic, and socio-occupational factors Study 6: Causal network analysis of sedation maintenance factors Timeline The project will take place over three years, with an 80:20 indicative split between academic (UEA) and clinical (CPFT) host organisations. Anticipated impact and dissemination The fellowship will produce a sedation assessment measure designed for use in NHS mental health settings, which will improve clinical awareness and management of sedation. It will advance our understanding of the impact of sedation - one of the most overlooked experiences in psychosis, linking to core challenges around poor recovery and outcomes. Research impact will be maximised by incorporation of patient and clinician perspectives, embedding of research work within clinical settings, and dissemination within each work package. In addition to these outcomes, the research will provide the necessary foundations for future intervention development.