Digital smartphone intervention to recognise and manage early warning signs in schizophrenia to prevent relapse : the EMPOWER feasibility cluster RCT

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Gumley, Andrew I. and Bradstreet, Simon and Ainsworth, John and Allan, Stephanie and Alvarez-Jimenez, Mario and Birchwood, Maximillian and Briggs, Andrew and Bucci, Sandra and Cotton, Sue and Engel, Lidia and French, Paul and Lederman, Reeva and Lewis, Shôn and Machin, Matthew and MacLennan, Graeme and McLeod, Hamish and McMeekin, Nicola and Mihalopoulos, Cathy and Morton, Emma and Norrie, John and Reilly, Frank and Schwannauer, Matthias and Singh, Swaran P. and Sundram, Suresh and Thompson, Andrew and Williams, Chris and Yung, Alison and Aucott, Lorna and Farhall, John and Gleeson, John (2022) Digital smartphone intervention to recognise and manage early warning signs in schizophrenia to prevent relapse : the EMPOWER feasibility cluster RCT. Health Technology Assessment, 26 (27). ISSN 2046-4924 (https://doi.org/10.3310/HLZE0479)

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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 and had a positive impact on motivations and intentions in relation to mental health. Actual app usage was high, with 91% of users who completed the baseline period meeting our a priori criterion of acceptable engagement (> 33%). The median time to discontinuation of > 33% app usage was 32 weeks (95% confidence interval 14 weeks to ∞). There were 8 out of 33 (24%) relapses in the EMPOWER arm and 13 out of 28 (46%) in the treatment-as-usual arm. Fewer participants in the EMPOWER arm had a relapse (relative risk 0.50, 95% confidence interval 0.26 to 0.98), and time to first relapse (hazard ratio 0.32, 95% confidence interval 0.14 to 0.74) was longer in the EMPOWER arm than in the treatment-as-usual group. At 12 months, EMPOWER participants were less fearful of having a relapse than those in the treatment-as-usual arm (mean difference –4.29, 95% confidence interval –7.29 to –1.28). EMPOWER was more costly and more effective, resulting in an incremental cost-effectiveness ratio of £3041. This incremental cost-effectiveness ratio would be considered cost-effective when using the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. Limitations: This was a feasibility study and the outcomes detected cannot be taken as evidence of efficacy or effectiveness. Conclusions: A trial of digital technology to monitor early warning signs that blended with peer support and clinical triage to detect and prevent relapse is feasible. Future work: A main trial with a sample size of 500 (assuming 90% power and 20% dropout) would detect a clinically meaningful reduction in relapse (relative risk 0.7) and improvement in other variables (effect sizes 0.3–0.4).

ORCID iDs

Gumley, Andrew I., Bradstreet, Simon, Ainsworth, John, Allan, Stephanie, Alvarez-Jimenez, Mario, Birchwood, Maximillian, Briggs, Andrew, Bucci, Sandra, Cotton, Sue, Engel, Lidia, French, Paul, Lederman, Reeva, Lewis, Shôn, Machin, Matthew, MacLennan, Graeme, McLeod, Hamish, McMeekin, Nicola, Mihalopoulos, Cathy, Morton, Emma, Norrie, John, Reilly, Frank ORCID logoORCID: https://orcid.org/0000-0002-3742-6668, Schwannauer, Matthias, Singh, Swaran P., Sundram, Suresh, Thompson, Andrew, Williams, Chris, Yung, Alison, Aucott, Lorna, Farhall, John and Gleeson, John;
CORE (COnnecting REpositories)