1. Digital smartphone intervention to recognise and manage early warning signs in schizophrenia to prevent relapse: the EMPOWER feasibility cluster RCT
- Author
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Gumley, AI, Bradstreet, S, Ainsworth, J, Allan, S, Alvarez-Jimenez, M, Birchwood, M, Briggs, A, Bucci, S, Cotton, S, Engel, L, French, P, Lederman, R, Lewis, S, Machin, M, Maclennan, G, McLeod, H, McMeekin, N, Mihalopoulos, C, Morton, E, Norrie, J, Reilly, F, Schwannauer, M, Singh, SP, Sundram, S, Thompson, A, Williams, C, Yung, A, Aucott, L, Farhall, J, Gleeson, J, Gumley, AI, Bradstreet, S, Ainsworth, J, Allan, S, Alvarez-Jimenez, M, Birchwood, M, Briggs, A, Bucci, S, Cotton, S, Engel, L, French, P, Lederman, R, Lewis, S, Machin, M, Maclennan, G, McLeod, H, McMeekin, N, Mihalopoulos, C, Morton, E, Norrie, J, Reilly, F, Schwannauer, M, Singh, SP, Sundram, S, Thompson, A, Williams, C, Yung, A, Aucott, L, Farhall, J, and Gleeson, J
- Abstract
Background: Relapse is a major determinant of outcome for people with a diagnosis of schizophrenia. Early warning signs frequently precede relapse. A recent Cochrane Review found low-quality evidence to suggest a positive effect of early warning signs interventions on hospitalisation and relapse. Objective: How feasible is a study to investigate the clinical effectiveness and cost-effectiveness of a digital intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? Design: A multicentre, two-arm, parallel-group cluster randomised controlled trial involving eight community mental health services, with 12-month follow-up. Settings: Glasgow, UK, and Melbourne, Australia. Participants: Service users were aged > 16 years and had a schizophrenia spectrum disorder with evidence of a relapse within the previous 2 years. Carers were eligible for inclusion if they were nominated by an eligible service user. Interventions: The Early signs Monitoring to Prevent relapse in psychosis and prOmote Wellbeing, Engagement, and Recovery (EMPOWER) intervention was designed to enable participants to monitor changes in their well-being daily using a mobile phone, blended with peer support. Clinical triage of changes in well-being that were suggestive of early signs of relapse was enabled through an algorithm that triggered a check-in prompt that informed a relapse prevention pathway, if warranted. Main outcome measures: The main outcomes were feasibility of the trial and feasibility, acceptability and usability of the intervention, as well as safety and performance. Candidate co-primary outcomes were relapse and fear of relapse. Results: We recruited 86 service users, of whom 73 were randomised (42 to EMPOWER and 31 to treatment as usual). Primary outcome data were collected for 84% of participants at 12 months. Feasibility data for people using the smartphone application (app) suggested that the app was easy to use an
- Published
- 2022