Early signs monitoring to prevent relapse in psychosis and promote well-being, engagement, and recovery: protocol for a feasibility cluster randomized controlled trial harnessing mobile phone technology blended with peer support

Gumley, A. et al. (2020) Early signs monitoring to prevent relapse in psychosis and promote well-being, engagement, and recovery: protocol for a feasibility cluster randomized controlled trial harnessing mobile phone technology blended with peer support. JMIR Research Protocols, 9(1), e15058. (doi:10.2196/15058) (PMID:31917372)

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Abstract

Background: Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. Objective: This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. Methods: We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. Results: Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. Conclusions: The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262 International Registered Report Identifier (IRRID): DERR1-10.2196/15058.

Item Type:Articles
Additional Information:This project was funded in the UK by the National Institute for Health Research Health Technology Assessment programme (project number 13/154/04) and in Australia by the National Heath and Medical Research Council (APP1095879). It will be published in full in the Health Technology Assessment. 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. M.A-J. is supported by a Career Development Fellowship (APP1082934) from the National Health and Medical Research Council. SA is supported by a Cremore Research Fellowship, bequested to the University of Glasgow.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Farhall, Professor John and Williams, Professor Chris and Bradstreet, Dr Simon and Wilson Kay, Mrs Alison and Beattie, Dr Louise and Mcmeekin, Mrs Nicola and Briggs, Professor Andrew and Allan, Ms Stephanie and Whitehill, Miss Helen and Norrie, Prof John and Matrunola, Miss Claire and Clark, Miss Andrea and Thomson, Mr David and Gumley, Professor Andrew and McLeod, Professor Hamish
Authors: Gumley, A., Bradstreet, S., Ainsworth, J., Allan, S., Alvarez-Jiminez, M., Beattie, L., Bell, I., Birchwood, M., Briggs, A., Bucci, S., Castagnini, E., Clark, A., Cotton, S. M., Engel, L., French, P., Lederman, R., Lewis, S., Machin, M., MacLennan, G., Matrunola, C., McLeod, H., McMeekin, N., Mihalopolous, C., Morton, E., Norrie, J., Reilly, F., Schwannauer, M., Singh, S. P., Smith, L., Sundram, S., Thomson, D., Thompson, A., Whitehill, H., Wilson-Kay, A., Williams, C., Yung, A., Farhall, J., and Gleeson, J.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Mental Health and Wellbeing
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:JMIR Research Protocols
Publisher:JMIR Publications
ISSN:1929-0748
ISSN (Online):1929-0748
Published Online:09 January 2020
Copyright Holders:Copyright © 2020 The Authors
First Published:First published in JMIR Research Protocols 9(1): e15058
Publisher Policy:Reproduced under a Creative Commons License

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