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

被引：23

作者：

Gumley, Andrew ^{[1
,2
]}

Bradstreet, Simon ^{[1
]}

Ainsworth, John ^{[3
]}

Allan, Stephanie ^{[1
]}

Alvarez-Jimenez, Mario ^{[4
,5
]}

Beattie, Louise ^{[1
]}

Bell, Imogen ^{[4
]}

Birchwood, Max ^{[6
]}

Briggs, Andrew ^{[7
]}

Bucci, Sandra ^{[8
,9
]}

Castagnini, Emily ^{[10
,11
]}

Clark, Andrea ^{[1
,12
]}

Cotton, Sue M. ^{[4
]}

Engel, Lidia ^{[13
]}

French, Paul ^{[14
]}

Lederman, Reeva ^{[15
]}

Lewis, Shon ^{[8
,9
]}

Machin, Matthew ^{[3
]}

MacLennan, Graeme ^{[16
]}

Matrunola, Claire ^{[1
,12
]}

McLeod, Hamish ^{[1
,2
]}

McMeekin, Nicola ^{[17
]}

Mihalopoulos, Cathrine ^{[13
]}

Morton, Emma ^{[18
]}

Norrie, John ^{[19
]}

Reilly, Frank ^{[20
]}

Schwannauer, Matthias ^{[21
]}

Singh, Swaran P. ^{[5
]}

Smith, Lesley ^{[20
]}

Sundram, Suresh ^{[22
]}

Thomson, David ^{[1
,2
]}

Thompson, Andrew ^{[3
,5
]}

Whitehill, Helen ^{[1
,20
]}

Wilson-Kay, Alison ^{[1
,2
]}

Williams, Christopher ^{[1
]}

Yung, Alison ^{[7
]}

Farhall, John ^{[9
,10
]}

Gleeson, John ^{[18
]}

机构：

[1] Univ Glasgow, Glasgow Mental Hlth Res Facil, Glasgow Inst Hlth & Wellbeing, Fleming Pavil,West Scotland Sci Pk,Todd Campus, Glasgow G20 0XA, Lanark, Scotland

[2] NHS Greater Glasgow & Clyde, Glasgow, Lanark, Scotland

[3] Univ Manchester, Sch Hlth Sci, Div Informat Imaging & Data Sci, Manchester, Lancs, England

[4] Natl Ctr Excellence Youth Mental Hlth, Orygen, Melbourne, Vic, Australia

[5] Univ Melbourne, Ctr Youth Mental Hlth, Melbourne, Vic, Australia

[6] Univ Warwick, Div Mental Hlth & Wellbeing, Warwick, England

[7] London Sch Hyg & Trop Med, London, England

[8] Univ Manchester, Sch Hlth Sci, Div Psychol & Mental Hlth, Manchester, Lancs, England

[9] Greater Manchester Mental Hlth NHS Fdn Trust, Manchester, Lancs, England

[10] La Trobe Univ, Melbourne, Vic, Australia

[11] NorthWestern Mental Hlth, Melbourne, Vic, Australia

[12] NHS Res Scotland Mental Hlth Network, Glasgow, Lanark, Scotland

[13] Deakin Univ, Melbourne, Vic, Australia

[14] Manchester Metropolitan Univ, Manchester, Lancs, England

[15] Univ Melbourne, Melbourne Sch Engn, Sch Comp & Informat Syst, Melbourne, Vic, Australia

[16] Univ Aberdeen, Ctr Healthcare Randomised Trials, Aberdeen, Scotland

[17] Univ Glasgow, Glasgow Inst Hlth & Wellbeing, Glasgow, Lanark, Scotland

[18] Australian Catholic Univ, Melbourne, Vic, Australia

[19] Univ Edinburgh, Usher Inst, Edinburgh, Midlothian, Scotland

[20] Scottish Recovery Network, Glasgow, Lanark, Scotland

[21] Univ Edinburgh, Sch Hlth & Social Sci, Edinburgh, Midlothian, Scotland

[22] Monash Univ, Melbourne, Vic, Australia

来源：

JMIR RESEARCH PROTOCOLS | 2020年 / 9卷 / 01期

基金：

英国医学研究理事会;

关键词：

schizophrenia; psychosis; relapse; mHealth; randomized controlled trial; ANTIPSYCHOTIC MEDICATION; 1ST-EPISODE PSYCHOSIS; CONSTRUCT-VALIDITY; RATING-SCALE; PROGRAM; SCHIZOPHRENIA; PREDICTORS; INTERVENTION; RELIABILITY; IMPLEMENTATION;

D O I：

10.2196/15058

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

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.

引用

页数：19