Authors' objectives: BACKGROUND: Relapse in schizophrenia is a major cause of distress and disability amongst patients and their families. Relapse is predicted by changes in symptoms such as anxiety, depression and suspiciousness (early warning signs, EWS) and can be used as the basis for timely interventions to prevent relapse and rehospitalisation. Research shows that interventions focused on EWS can reduce these negative outcomes and enhance recovery. The quality of research evidence is poor so that it is not possible to estimate whether these can be applied in routine practice. AIMS: To build an intervention (EMPOWER) that refines existing digital smartphone technology for the monitoring of EWS; that promotes help seeking and minimises the risk of false alarms. Therefore, we will seek to embed our digital technology into a Stepped-Care approach to enhance self- management and facilitate timely intervention from mental health services.? PARTICIPANTS: Eligible service users will be (i) adults (age 16+) (ii) in contact with a local community based services; (iii) who have been admitted to a psychiatric in-patient service at least once in the previous two years for a relapse of psychosis; (iv) a DSM-V diagnosis of Schizophrenia. Service users will also be invited to nominate a carer to participate.? SETTINGS: The study will take place in Glasgow (UK) and Melbourne (Australia).? DESIGN AND PROCEDURES: The study will last for 30-months. During months 3 to 10 we will explore the views of service users, carers and staff in integrate these into refinements to maximise acceptability of our digital technology. Months 11 to 12 we will undertake preliminary tests of this technology to further enhance acceptability. Months 13 to 27 we will undertake a pilot cluster randomised controlled trial where we will randomise Community Mental Health Teams (CMHTs) to EMPOWER or to Treatment as Usual. We aim to recruit 120 service user participants from 8 CMHTs and follow them up for 12-months. This pilot will enable us to investigate the feasibility of a larger scale (definitive) trial and the acceptability and safety of the EMPOWER intervention. Months 22 to 27 we will conduct a Health Economic study and we will also undertake wider engagement of service user, carer and NHS stakeholders to facilitate transition to the main study. Months 28 to 30 will involve analysis and write up of the study findings. INTERVENTION: The EMPOWER intervention involves three levels of stepped care: (i) smartphone based early signs monitoring, (ii) individualised self-management support delivered through smartphone, and (iii) activation of a relapse prevention pathway into secondary care. Service user participants will have access to the EMPOWER App for the full 12-months of the study. EMPOWER will enable service users, their nominated carer and their care coordinator will agree and personalize (i) frequency settings (number of EWS alerts per day/week); (ii) thresholds for increasing the frequency of monitoring and delivery of motivational self-management messages and (iii) thresholds for activating the relapse prevention pathway. OUTCOMES: We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability and safety of the EMPOWER intervention. We will assess relapse, symptom recovery, emotional recovery, empowerment and engagement. We will manualise the intervention and establish the methods to deliver the main (definitive) trial.

Project Status: Ongoing

URL for project: http://www.nets.nihr.ac.uk/projects/hta/1315404

Anticipated Publish Date: 2021

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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