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.
| Original language | English |
|---|---|
| Article number | e15058 |
| Pages (from-to) | e15058 |
| Number of pages | 19 |
| Journal | JMIR Research Protocols |
| Volume | 9 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 9 Jan 2020 |
Bibliographical note
AcknowledgmentsThe 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.
Authors' Contributions
Keywords
- MHealth
- Psychosis
- Randomized controlled trial
- Relapse
- Schizophrenia
Access to Document
- Gumley_EarlySignsMonitoring_VOR
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