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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, Andrew; Bradstreet, Simon; Ainsworth, John; Allan, Stephanie; Alvarez-Jimenez, Mario; Beattie, Louise; Bell, Imogen; Birchwood, Max; 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, Frank; Schwannauer, Matthias; Singh, Swaran P; Smith, Lesley; Sundram, Suresh; Thomson, David; Thompson, Andrew; Whitehill, Helen; Wilson-Kay, Alison; Williams, Christopher; Yung, Alison; Farhall, John; Gleeson, John.
Afiliação
  • Gumley A; Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.
  • Bradstreet S; NHS Greater Glasgow and Clyde, Glasgow, United Kingdom.
  • Ainsworth J; Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.
  • Allan S; Division of Informatics, Imaging, and Data Sciences, School of Health Sciences, University of Manchester, Manchester, United Kingdom.
  • Alvarez-Jimenez M; Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.
  • Beattie L; Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, Australia.
  • Bell I; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia.
  • Birchwood M; Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.
  • Briggs A; Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, Australia.
  • Bucci S; Division of Mental Health and Wellbeing, University of Warwick, Warwick, United Kingdom.
  • Castagnini E; London School of Hygiene and Tropical Medicine, London, United Kingdom.
  • Clark A; Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, United Kingdom.
  • Cotton SM; Greater Manchester Mental Health NHS Foundation Trust, Manchester, United Kingdom.
  • Engel L; La Trobe University, Melbourne, Australia.
  • French P; NorthWestern Mental Health, Melbourne, Australia.
  • Lederman R; Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.
  • Lewis S; NHS Research Scotland Mental Health Network, Glasgow, United Kingdom.
  • Machin M; Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, Australia.
  • MacLennan G; Deakin University, Melbourne, Australia.
  • Matrunola C; Manchester Metropolitan University, Manchester, United Kingdom.
  • McLeod H; School of Computing and Information Systems, Melbourne School of Engineering, University of Melbourne, Melbourne, Australia.
  • McMeekin N; Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, United Kingdom.
  • Mihalopoulos C; Greater Manchester Mental Health NHS Foundation Trust, Manchester, United Kingdom.
  • Morton E; Division of Informatics, Imaging, and Data Sciences, School of Health Sciences, University of Manchester, Manchester, United Kingdom.
  • Norrie J; The Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, United Kingdom.
  • Reilly F; Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.
  • Schwannauer M; NHS Research Scotland Mental Health Network, Glasgow, United Kingdom.
  • Singh SP; Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.
  • Smith L; NHS Greater Glasgow and Clyde, Glasgow, United Kingdom.
  • Sundram S; Glasgow Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.
  • Thomson D; Deakin University, Melbourne, Australia.
  • Thompson A; Australian Catholic University, Melbourne, Australia.
  • Whitehill H; Usher Institute, University of Edinburgh, Edinburgh, United Kingdom.
  • Wilson-Kay A; Scottish Recovery Network, Glasgow, United Kingdom.
  • Williams C; School of Health and Social Sciences, University of Edinburgh, Edinburgh, United Kingdom.
  • Yung A; Division of Mental Health and Wellbeing, University of Warwick, Warwick, United Kingdom.
  • Farhall J; Scottish Recovery Network, Glasgow, United Kingdom.
  • Gleeson J; Monash University, Melbourne, Australia.
JMIR Res Protoc ; 9(1): e15058, 2020 Jan 09.
Article em En | MEDLINE | ID: mdl-31917372
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Diagnostic_studies / Prognostic_studies Idioma: En Revista: JMIR Res Protoc Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Reino Unido

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Diagnostic_studies / Prognostic_studies Idioma: En Revista: JMIR Res Protoc Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Reino Unido