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

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

mHealth for schizophrenia spectrum disorders management: A systematic review

“…Due to the ability to capture slight changes in behavior, this technology may permit surveillance for early signs of symptomatic relapse. The EMA approach creates an opportunity to extend knowledge on disease and to find correlations between symptoms and risk factors, for example, anxiety, depression and suspiciousness can contribute to relapse in schizophrenia (Gumley et al, 2020). In addition, it may, through the gathering of large volumes of data by EMA applications, allow for prediction of future symptom exacerbation – as in ITAREPS (Komatsu et al, 2013; Španiel et al, 2012; Španiel, Vohlidka, Hrdlicka, et al, 2008; Španiel, Vohlídka, Kožený, et al, 2008) and CrossCheck (Ben-Zeev et al, 2017; Wang et al, 2016, 2017).…”

Trial staff views on barriers recruitment in a digital intervention for psychosis and how to work around them: A qualitative study within a trial

“…Recovery (38), ISRCTN: 99559262) aimed to develop and evaluate a Mobile App for use with adults who experience psychosis. The EMPOWER App is a digital self-management tool (augmented with peer support) to enhance the identi cation of, and communication about early warning signs of relapse in people diagnosed with schizophrenia.…”

“…Therefore, developing an understanding of recruitment both within and across sites appears important in contextualising the recruitment process in a cRCT. Full details of the intervention are reported in the protocol (38). In a feasibility study such as EMPOWER, process evaluators are usually interested in facilitators and barriers to implementation so that strategies to enhance implementation of key processes such as recruitment can be put in place for a de nitive trial (17).…”

“…NVIVO (50) software was used for all analysis. SA is a PhD student working on a process evaluation for the EMPOWER cRCT (38). The PhD funding SA receives is independent of any funding associated with the trial.…”

Innovative digitale Versorgungsformen zur Personalisierung der stationsäquivalenten Behandlung in der alltäglichen Lebenswelt bei schweren psychischen Erkrankungen [Innovative digital forms of service delivery for personalized crisis resolution and home treatment for people with severe mental health problems]

“…im Bereich der Gerontopsychiatrie (Nijhof et al, 2013, Realdon et al, 2016. Im Bereich der StäB bei langandauernden und schweren psychischen (Byrne et al, 2020, Ebner-Priemer et al, 2006, Faurholt-Jepsen et al, 2016, Gumley et al, 2020, Hartmann et al, 2015, Kramer et al, 2014, Muhlbauer et al, 2018, Stahl et al, 2020. Dabei muss sich das digitale Monitoring nicht ausschließlich auf die Erfassung von Symptomen und Bedarfen beschränken, sondern könnte das multiprofessionelle Team auch bei weiteren wichtigen Aufgaben, wie der klinisch psychologischen Diagnostik, Dokumentation des Pflegeprozesses,…”