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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

Gumley, A., Bradstreet, S., Ainsworth, J., Allan, S., Alvarez-Jimenez, M., Beattie, L., Bell, I., Birchwood, M., Briggs, A., Bucci, S., Castagnini, E., Clark, A., Cotton, S.M., Engel, Lidia, French, P., Lederman, R., Lewis, S., Machin, M., MacLennan, G., Matrunola, C., McLeod, H., McMeekin, N., Mihalopoulos, Cathrine, Morton, E., Norrie, J., Reilly, F., Schwannauer, M., Singh, S.P., Smith, L., Sundram, S., Thomson, D., Thompson, A., Whitehill, H., Wilson-Kay, A., Williams, C., Yung, A., Farhall, J. and Gleeson, J. 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, vol. 9, no. 1, pp. 1-19, doi: 10.2196/15058.

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Title 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
Author(s) Gumley, A.
Bradstreet, S.
Ainsworth, J.
Allan, S.
Alvarez-Jimenez, M.
Beattie, L.
Bell, I.
Birchwood, M.
Briggs, A.
Bucci, S.
Castagnini, E.
Clark, A.
Cotton, S.M.
Engel, LidiaORCID iD for Engel, Lidia orcid.org/0000-0002-7959-3149
French, P.
Lederman, R.
Lewis, S.
Machin, M.
MacLennan, G.
Matrunola, C.
McLeod, H.
McMeekin, N.
Mihalopoulos, CathrineORCID iD for Mihalopoulos, Cathrine orcid.org/0000-0002-7127-9462
Morton, E.
Norrie, J.
Reilly, F.
Schwannauer, M.
Singh, S.P.
Smith, L.
Sundram, S.
Thomson, D.
Thompson, A.
Whitehill, H.
Wilson-Kay, A.
Williams, C.
Yung, A.
Farhall, J.
Gleeson, J.
Journal name JMIR Research Protocols
Volume number 9
Issue number 1
Article ID e15058
Start page 1
End page 19
Total pages 19
Publisher JMIR Publications
Place of publication Toronto, Ont.
Publication date 2020-01
ISSN 1929-0748
1929-0748
Keyword(s) Science & Technology
Life Sciences & Biomedicine
Health Care Sciences & Services
schizophrenia
psychosis
relapse
mHealth
randomized controlled trial
ANTIPSYCHOTIC MEDICATION
1ST-EPISODE PSYCHOSIS
CONSTRUCT-VALIDITY
RATING-SCALE
PROGRAM
PREDICTORS
INTERVENTION
RELIABILITY
IMPLEMENTATION
Summary 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
Language eng
DOI 10.2196/15058
Indigenous content off
Field of Research 111714 Mental Health
140208 Health Economics
1103 Clinical Sciences
1117 Public Health and Health Services
Socio Economic Objective 920410 Mental Health
HERDC Research category C1 Refereed article in a scholarly journal
Free to Read? Yes
Persistent URL http://hdl.handle.net/10536/DRO/DU:30133707

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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.