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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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(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 ISSN 1929-0748.
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WRAP-early-signs-monitoring-prevent-relapse-psychosis-promote-well-being-engagement-recovery-Singh-2020.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1025Kb) | Preview |
Official URL: http://dx.doi.org/10.2196/15058
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.
| Item Type: | Journal Article | ||||||||||||||||||
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| Subjects: | B Philosophy. Psychology. Religion > BF Psychology R Medicine > R Medicine (General) R Medicine > RC Internal medicine |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Mental Health and Wellbeing Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Schizophrenia, Schizophrenia -- Treatment, Schizophrenics -- Care, Schizophrenics -- Mental health services, Schizophrenics -- Rehabilitation -- Social aspects, Schizophrenia -- Relapse, Psychoses, Psychoses -- Patients -- Treatment, Psychoses -- Relapse, Clinical trials, Peer counseling , Hotlines (Counseling) | ||||||||||||||||||
| Journal or Publication Title: | JMIR Research Protocols | ||||||||||||||||||
| Publisher: | JMIR Publications, Inc. | ||||||||||||||||||
| ISSN: | 1929-0748 | ||||||||||||||||||
| Official Date: | 9 January 2020 | ||||||||||||||||||
| Dates: |
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| Volume: | 9 | ||||||||||||||||||
| Number: | 1 | ||||||||||||||||||
| Article Number: | e15058 | ||||||||||||||||||
| DOI: | 10.2196/15058 | ||||||||||||||||||
| Status: | Peer Reviewed | ||||||||||||||||||
| Publication Status: | Published | ||||||||||||||||||
| Reuse Statement (publisher, data, author rights): | Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.01.2020. | ||||||||||||||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||||||||||||||
| Date of first compliant deposit: | 4 March 2021 | ||||||||||||||||||
| Date of first compliant Open Access: | 5 March 2021 | ||||||||||||||||||
| RIOXX Funder/Project Grant: |
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| Is Part Of: | 1 |
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