TY - JOUR
T1 - Early signs monitoring to prevent relapse in psychosis and promote well-being, engagement, and recovery
T2 - Protocol for a feasibility cluster randomized controlled trial harnessing mobile phone technology blended with peer support
AU - Gumley, Andrew
AU - Bradstreet, Simon
AU - Ainsworth, John
AU - Allan, Stephanie
AU - Alvarez-Jimenez, Mario
AU - Beattie, Louise
AU - Bell, Imogen
AU - Birchwood, Max
AU - Briggs, Andrew
AU - Bucci, Sandra
AU - Castagnini, Emily
AU - Clark, Andrea
AU - Cotton, Sue M
AU - Engel, Lidia
AU - French, Paul
AU - Lederman, Reeva
AU - Lewis, Shon
AU - Machin, Matthew
AU - MacLennan, Graeme
AU - Matrunola, Claire
AU - McLeod, Hamish
AU - McMeekin, Nicola
AU - Mihalopoulos, Cathrine
AU - Morton, Emma
AU - Norrie, John
AU - Reilly, Frank
AU - Schwannauer, Matthias
AU - Singh, Swaran P
AU - Smith, Lesley
AU - Sundram, Suresh
AU - Thomson, David
AU - Thompson, Andrew
AU - Whitehill, Helen
AU - Wilson-Kay, Alison
AU - Williams, Christopher
AU - Yung, Alison
AU - Farhall, John
AU - Gleeson, John
N1 - Funding Information:
AG reports personal fees from the University of Manchester, personal fees from the University of Exeter, personal fees from BABCP, and other interests with NHS Education for Scotland outside the submitted work. JA and SB report other interests with Affigo CIC, outside the submitted work. AB reports personal fees from Bayer, Merck, Janssen, Novartis, Sword Health, Amgen, and Daiichi Sankyo outside the submitted work. JF reports grants from National Health & Medical Research Council (Australia) during the conduct of the study and other interests with Melbourne Health (NorthWestern Mental Health) outside the submitted work. SL reports grants from MRC, nonfinancial support from Affigo CIC, and personal fees from Xenzone PLC outside the submitted work. HMcL reports grants from NIHR HTA during the conduct of the study. CM reports grants from National Health & Medical Research Council (Australia) during the conduct of the study. JN reports grants from the University of Aberdeen and the University of Edinburgh during the conduct of the study and declares membership of the following NIHR boards: CPR decision-making committee; HTA Commissioning Board; HTA Commissioning Sub-Board (EOI); HTA Funding Boards Policy Group; HTA General Board; HTA Post-Board funding teleconference; NIHR CTU Standing Advisory Committee; NIHR HTA & EME Editorial Board; and Pre-exposure Prophylaxis Impact Review Panel. CW reports grants from NIHR during the conduct of the study and other interests with Five Areas Ltd outside the submitted work. MA-J was supported by a Career Development Fellowship (APP1082934) from the National Health and Medical Research Council. SA, SBr, SS, MS, FR, MB, SSu, PF, SC, LE, EM, GMacL, NMcM, AT, MM, RL, DT, HW, IB, AW-K, and LB all declare no conflicts of interest outside the submitted work.
Funding Information:
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 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.
Publisher Copyright:
© Andrew Gumley, Simon Bradstreet, John Ainsworth, Stephanie Allan, Mario Alvarez-Jimenez, Louise Beattie, Imogen Bell, Max Birchwood, Andrew Briggs, Sandra Bucci, Emily Castagnini, Andrea Clark, Sue M Cotton, Lidia Engel, Paul French, Reeva Lederman, Shon Lewis, Matthew Machin, Graeme MacLennan, Claire Matrunola, Hamish McLeod, Nicola McMeekin, Cathrine Mihalopoulos, Emma Morton, John Norrie, Frank Reilly, Matthias Schwannauer, Swaran P Singh, Lesley Smith, Suresh Sundram, David Thomson, Andrew Thompson, Helen Whitehill, Alison Wilson-Kay, Christopher Williams, Alison Yung, John Farhall, John Gleeson.
PY - 2020/1/9
Y1 - 2020/1/9
N2 - 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.
AB - 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.
KW - MHealth
KW - psychosis
KW - randomized controlled trial
KW - relapse
KW - schizophrenia
UR - http://www.scopus.com/inward/record.url?eid=2-s2.0-85083214430&partnerID=MN8TOARS
U2 - 10.2196/15058
DO - 10.2196/15058
M3 - Article
C2 - 31917372
SN - 1929-0748
VL - 9
SP - 1
EP - 19
JO - JMIR research protocols
JF - JMIR research protocols
IS - 1
M1 - e15058
ER -