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
Andrew Gumley, Simon Bradstreet, John Ainsworth, Stephanie Allan, Mario Alvarez-Jimenez, Louise Beattie, Imogen Bell, Max Birchwood, Andrew Briggs, Sandra Bucci, Emily Castagnini, Andrea Clark, Sue M Cotton, Lidia Engel, Paul French, Reeva Lederman, Shon Lewis, Matthew Machin, Graeme MacLennan, Claire Matrunola Show all
JMIR Research Protocols | JMIR PUBLICATIONS, INC | Published : 2020
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 paramete..View full abstract
Awarded by National Institute for Health Research Health Technology Assessment program
Awarded by National Health and Medical Research Council
The authors are grateful to all the service users, carers, and mental health staff and CMHSs who gave their time and resources to contribute to the development of this study during the consultation phase. This was critical in shaping the refinement of the EMPOWER intervention and outcomes. The authors are grateful to all the service users, carers, and mental health staff and CMHSs who gave their time and resources to contribute to the cRCT. The authors also express their gratitude to their SSC members, Professor David Kingdon (Chair), Professor Daniel Freeman (independent member), Professor Fiona Lobban (independent member), David Kavanagh (independent member), Frances Simpson (independent public and patient involvement representative), and Graham Morgan (independent public and patient involvement representative). The authors express their gratitude to their Data Monitoring and Ethics Committee members, Professor Emmanuelle Peters (Chair), Dr Alison Brabban (independent clinician), Professor Rod Taylor (independent statistician), and Professor Greg Murray (independent statistician). This study was funded in the United Kingdom by the National Institute for Health Research Health Technology Assessment program (project number 13/154/04) and in Australia by the National Health 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. MA-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. The study sponsors and funders were not involved in the study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.