Understanding implementation of a digital self-monitoring intervention for relapse prevention in psychosis: protocol for a mixed methods process evaluation

Allan, S., McLeod, H. , Bradstreet, S. , Beedie, S., Moir, B., Gleeson, J., Farhall, J., Morton, E. and Gumley, A. (2019) Understanding implementation of a digital self-monitoring intervention for relapse prevention in psychosis: protocol for a mixed methods process evaluation. JMIR Research Protocols, 8(12), e15634. (doi: 10.2196/15634) (PMID:31821154) (PMCID:PMC6930509)

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Background: Relapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility. Objective: This study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report. Methods: The overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies. Results: The results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019. Conclusions: The findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial.

Item Type:Articles
Additional Information:The EMPOWER trial 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 Health and MRC (APP1095879). It will be published in full in the Health Technology Assessment. The EMPOWER 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. SA was funded by the Cremore Research Fellowship.
Glasgow Author(s) Enlighten ID:Bradstreet, Dr Simon and Moir, Miss Bethany and McLeod, Professor Hamish and Farhall, Professor John and Allan, Ms Stephanie and Beedie, Dr Sara and Gumley, Professor Andrew
Authors: Allan, S., McLeod, H., Bradstreet, S., Beedie, S., Moir, B., Gleeson, J., Farhall, J., Morton, E., and Gumley, A.
College/School: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
College of Science and Engineering > School of Psychology
Journal Name:JMIR Research Protocols
Publisher:JMIR Publications
ISSN (Online):1929-0748
Published Online:10 December 2019
Copyright Holders:Copyright © 2019 Stephanie Allan, Hamish Mcleod, Simon Bradstreet, Sara Beedie, Bethany Moir, John Gleeson, John Farhall, Emma Morton, Andrew Gumley
First Published:First published in JMIR Research Protocols 8(12):e15634
Publisher Policy:Reproduced under a Creative Commons License

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