The EMPOWER blended digital intervention for relapse prevention in schizophrenia: a feasibility cluster randomised controlled trial in Scotland and Australia

Andrew I. Gumley*, Simon Bradstreet, John Ainsworth, Stephanie Allan, Mario Alvarez-Jimenez, Lorna Aucott, Maximillian Birchwood, Andrew Briggs, Sandra Bucci, Sue M. Cotton, Lidia Engel, Paul French, Reeva Lederman, Shôn Lewis, Matthew Machin, Graeme MacLennan, Hamish McLeod, Nicola McMeekin, Cathy Mihalopoulos, Emma MortonJohn Norrie, Matthias Schwannauer, Swaran P. Singh, Suresh Sundram, Andrew Thompson, Chris Williams, Alison R. Yung, John Farhall, John Gleeson

*Corresponding author for this work

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Abstract

Background: Early warning signs monitoring by service users with schizophrenia has shown promise in preventing relapse but the quality of evidence is low. We aimed to establish the feasibility of undertaking a definitive randomised controlled trial to determine the effectiveness of a blended digital intervention for relapse prevention in schizophrenia. Methods: This multicentre, feasibility, cluster randomised controlled trial aimed to compare Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) with treatment as usual in community mental health services (CMHS) in Glasgow and Melbourne. CMHS were the unit of randomisation, selected on the basis of those that probably had five or more care coordinators willing to participate. Participants were eligible if they were older than 16 years, had a schizophrenia or related diagnosis confirmed via case records, were able to provide informed consent, had contact with CMHS, and had had a relapse within the previous 2 years. Participants were randomised within stratified clusters to EMPOWER or to continue their usual approach to care. EMPOWER blended a smartphone for active monitoring of early warning signs with peer support to promote self-management and clinical triage to promote access to relapse prevention. Main outcomes were feasibility, acceptability, usability, and safety, which was assessed through face-to-face interviews. App usage was assessed via the smartphone and self-report. Primary end point was 12 months. Participants, research assistants and other team members involved in delivering the intervention were not masked to treatment conditions. Assessment of relapse was done by an independent adjudication panel masked to randomisation group. The study is registered at ISRCTN (99559262). Findings: We identified and randomised eight CMHS (six in Glasgow and two in Melbourne) comprising 47 care coordinators. We recruited 86 service users between Jan 19 and Aug 8, 2018; 73 were randomised (42 [58%] to EMPOWER and 31 [42%] to treatment as usual). There were 37 (51%) men and 36 (49%) women. At 12 months, main outcomes were collected for 32 (76%) of service users in the EMPOWER group and 30 (97%) of service users in the treatment as usual group. Of those randomised to EMPOWER, 30 (71%) met our a priori criterion of more than 33% adherence to daily monitoring that assumed feasibility. Median time to discontinuation of these participants was 31·5 weeks (SD 14·5). There were 29 adverse events in the EMPOWER group and 25 adverse events in the treatment as usual group. There were 13 app-related adverse events, affecting 11 people, one of which was serious. Fear of relapse was lower in the EMPOWER group than in the treatment as usual group at 12 months (mean difference –7·53 (95% CI –14·45 to 0·60; Cohen's d –0·53). Interpretation: A trial of digital technology to monitor early warning signs blended with peer support and clinical triage to detect and prevent relapse appears to be feasible, safe, and acceptable. A further main trial is merited. Funding: UK National Institute for Health Research Health Technology Assessment programme and the Australian National Health and Medical Research Council.

Original languageEnglish
Pages (from-to)477-486
Number of pages10
JournalThe Lancet Psychiatry
Volume9
Issue number6
Early online date12 May 2022
DOIs
Publication statusPublished - Jun 2022

Bibliographical note

Funding Information:
AIG reports personal fees from University of Manchester, personal fees from University of Exeter, personal fees from British Association for Behavioural and Cognitive Psychotherapies and other interests with UK National Health Service (NHS) Education for Scotland outside the submitted work. JA, SL, and SB report other interests with CareLoop Health, outside the submitted work. SB reports grants from the Medical Research Council and UK National Institute for Health Research (NIHR) during the conduct of the study. SL reports grants from the UK Medical Research Council (MRC) during the conduct of the study. JA reports grants from MRC, Engineering and Physical Sciences Research Council, Economic and Social Research Council, NIHR, and the US National Institute for Health, and was a Fellow of the Alan Turing Institute during the conduct of the study. AB reports personal fees from Bayer, Merck, Janssen, Novartis, Sword Health, Amgen, and Daiichi Sankyo outside the submitted work. JF reports grants from National Health and Medical Research Council (Australia) during the conduct of the study and other interests with Melbourne Health (NorthWestern Mental Health) outside the submitted work. HMcL reports grants from NIHR Health Technology Assessment (HTA) during the conduct of the study, and grants with Academy of Medical Sciences, Glasgow Children's Hospital Charity, and Scotland's Chief Scientist's Office. CM reports grants from National Health and Medical Research Council (Australia) during the conduct of the study. JN reports grants from the University of Aberdeen and the University of Edinburgh during the conduct of the study and declares membership of the following NIHR boards: Cardio Pulmonary Resusitation decision making committee; HTA commissioning board; HTA commissioning sub-board (expression of interest); HTA funding boards policy group; HTA general board; HTA post-board funding teleconference; NIHR clinical trials unit standing advisory committee; NIHR HTA and Efficacy Mechanism Evaluation editorial board; pre-exposure prophylaxis impact review panel. PF is a member of the HTA mental health prioritisation panel. CW reports grants from NIHR during the conduct of the study and from the Royal College of Psychiatrists, and other interests with Five Areas outside the submitted work. AY reports an NIHR Senior Investigator Grant. JG reports grants from the National Health Medical Research Council. All other authors declare no competing interests.

Funding Information:
This project was funded in the UK by the NIHR-HTA programme (project number 13/154/04) and in Australia by the National Heath and Medical Research Council (APP1095879). The research will be published in full in the HTA. This study is supported by NHS Research Scotland, through the Chief Scientist Office and the NHS Scotland Mental Health Network. The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health Directorate. MA-J is supported by an Investigator Grant (APP1177235) from the National Health and Medical Research Council and a Dame Kate Campbell Fellowship from The University of Melbourne. MB and SS are supported by NIHR Applied Research Centre (ARC) West Midlands. SA is supported by a Cremore Research Fellowship, donated to the University of Glasgow. This independent research study was funded by the UK NIHR-HTA. The views expressed in this publication are those of the authors and not necessarily of the NHS, the National Institute for Health Research, or the UK Department of Health and Social Care. The study sponsors and funders were not involved in the study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication. We would like to thank health and care providers in Scotland and Australia who contributed to the study and of course to all the service users and their supporters who participated in this research. We sincerely hope we have met your expectations in taking part. We would like to acknowledge and recognise the contribution of members of the research team not listed as authors. These include Imogen Bell, Emily Castagnini, Andrea Clark, Amy Hood, Maria Lambrou, Casey Lynch, Casey McCrae, Ishani Majmudar, Claire Matrunola, Giada Micolucci, Sophie Norman, Lesley Smith, Suzy Syrett, David Thomson, Helen Whitehill, and Alison Wilson Kay. We also express our gratitude to our Study Steering Committee members: Prof David Kingdon (Chair), Prof Daniel Freeman (independent member), Prof Fiona Lobban (independent member), David Kavanagh (independent member), and Graham Morgan (Independent Public and Patient Involvement Representative). We also express our gratitude to our Data Monitoring and Ethics Committee members: Prof Emmanuelle Peters (Chair), Dr Alison Brabban (Independent Clinician), Prof Rod Taylor (Independent Statistician), and Prof Greg Murray (Independent Statistician).

Funding Information:
This project was funded in the UK by the NIHR-HTA programme (project number 13/154/04) and in Australia by the National Heath and Medical Research Council (APP1095879). The research will be published in full in the HTA. This study is supported by NHS Research Scotland, through the Chief Scientist Office and the NHS Scotland Mental Health Network. The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health Directorate. MA-J is supported by an Investigator Grant (APP1177235) from the National Health and Medical Research Council and a Dame Kate Campbell Fellowship from The University of Melbourne. MB and SS are supported by NIHR Applied Research Centre (ARC) West Midlands. SA is supported by a Cremore Research Fellowship, donated to the University of Glasgow. This independent research study was funded by the UK NIHR-HTA. The views expressed in this publication are those of the authors and not necessarily of the NHS, the National Institute for Health Research, or the UK Department of Health and Social Care. The study sponsors and funders were not involved in the study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication. We would like to thank health and care providers in Scotland and Australia who contributed to the study and of course to all the service users and their supporters who participated in this research. We sincerely hope we have met your expectations in taking part. We would like to acknowledge and recognise the contribution of members of the research team not listed as authors. These include Imogen Bell, Emily Castagnini, Andrea Clark, Amy Hood, Maria Lambrou, Casey Lynch, Casey McCrae, Ishani Majmudar, Claire Matrunola, Giada Micolucci, Sophie Norman, Lesley Smith, Suzy Syrett, David Thomson, Helen Whitehill, and Alison Wilson Kay. We also express our gratitude to our Study Steering Committee members: Prof David Kingdon (Chair), Prof Daniel Freeman (independent member), Prof Fiona Lobban (independent member), David Kavanagh (independent member), and Graham Morgan (Independent Public and Patient Involvement Representative). We also express our gratitude to our Data Monitoring and Ethics Committee members: Prof Emmanuelle Peters (Chair), Dr Alison Brabban (Independent Clinician), Prof Rod Taylor (Independent Statistician), and Prof Greg Murray (Independent Statistician).

Publisher Copyright:
© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license

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