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 |
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| 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: | Mcmeekin, Dr Nicola and Williams, Professor Christopher and Bradstreet, Dr Simon and Wilson Kay, Mrs Alison and Whitehill, Miss Helen and Matrunola, Miss Claire and Thomson, Mr David and McLeod, Professor Hamish and Farhall, Professor John and Allan, Ms Stephanie and Norrie, Prof John and Beattie, Dr Louise and Briggs, Professor Andrew and Clark, Miss Andrea and Gumley, Professor Andrew |
| 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 > School of Health & Wellbeing > Health Economics and Health Technology Assessment College of Medical Veterinary and Life Sciences > School of Health & 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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