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

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Gumley, Andrew and Bradstreet, Simon and Ainsworth, John and Allan, Stephanie and Alvarez-Jimenez, Mario and Beattie, Louise and Bell, Imogen and Birchwood, Maximillian and Briggs, Andrew and Bucci, Sandra and Castagnini, Emily and Clark, Andrea and Cotton, Sue M and Engel, Lidia and French, Paul and Lederman, Reeva and Lewis, Shon and Machin, Matthew and MacLennan, Graeme and Matrunola, Claire and McLeod, Hamish and McMeekin, Nicola and Mihalopoulos, Cathrine and Morton, Emma and Norrie, John and Reilly, Francis and Schwannauer, Matthias and Singh, Swaran P and Smith, Lesley and Sundram, Suresh and Thomson, David and Thompson, Andrew and Whitehill, Helen and Wilson-Kay, Alison and Williams, Christopher and Yung, Alison and Farhall, John and Gleeson, John (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. ISSN 1929-0748 (https://doi.org/10.2196/15058)

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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

ORCID iDs

Gumley, Andrew, Bradstreet, Simon, Ainsworth, John, Allan, Stephanie, Alvarez-Jimenez, Mario, Beattie, Louise, Bell, Imogen, Birchwood, Maximillian, Briggs, Andrew, Bucci, Sandra, Castagnini, Emily, Clark, Andrea, Cotton, Sue M, Engel, Lidia, French, Paul, Lederman, Reeva, Lewis, Shon, Machin, Matthew, MacLennan, Graeme, Matrunola, Claire, McLeod, Hamish, McMeekin, Nicola, Mihalopoulos, Cathrine, Morton, Emma, Norrie, John, Reilly, Francis ORCID logoORCID: https://orcid.org/0000-0002-3742-6668, Schwannauer, Matthias, Singh, Swaran P, Smith, Lesley, Sundram, Suresh, Thomson, David, Thompson, Andrew, Whitehill, Helen, Wilson-Kay, Alison, Williams, Christopher, Yung, Alison, Farhall, John and Gleeson, John;
CORE (COnnecting REpositories)