# Digital smartphone intervention to recognise and manage early warning signs in schizophrenia to prevent relapse: the EMPOWER feasibility cluster RCT Gumley, A. I.; Bradstreet, S.; Ainsworth, J.; Allan, S.; Alvarez-Jimenez, M.; Birchwood, M.; Briggs, A.; Bucci, S.; Cotton, S.; Engel, L.; French, P.; Lederman, R.; Lewis, S.; Machin, M.; MacLennan, G.; McLeod, H.; McMeekin, N.; Mihalopoulos, C.; Morton, E.; Norrie, J.; Reilly, F.; Schwannauer, M.; Singh, S. P.; Sundram, S.; Thompson, A.; Williams, C.; Yung, A.; Aucott, L.; Farhall, J.; Gleeson, J. Health technology assessment (Winchester, England) 2022;26(27):1-174 United Kingdom NLM (Medline) 2022 DOI: [10.3310/HLZE0479](https://dx.doi.org/10.3310/HLZE0479) ![[2039698.pdf]] --- Assessements used. 1. Feasibility at baseline, 3, 6, 12 months 2. Acceptability and usability, baseline, 3, 6, 12 3. Relapse at 3, 6, 12 4. PANSS baseline 3, 6, 12 5. Personal and Social Performance Scale 6. CDSS 7. Timeline feedback 8. HADS 9. PBIQ-R 10. Service Attachment Questionnaire 11. Medication Adherence Rating Scale 12. EuroQol-5 Dimensions 13. Assessment of Quality of Life 14. Resource Use Questionnaire 15. Questionnaire about the process of recovery 16. General Self-Efficacy Scale 17. Psychosis Attacement Measure 18. Percieved Criticism and Warmth Measure Carer Assessments 1. Feasibility 2. Carer Quality of Life-7 Dimensions 3. EuroQol-5 Dimensions, Five-level Version 4. Resource use questionnaire 5. Percieved Critisim and Warmth Measure 6. Involvement Evaluation Questionnare Care Coordinator 1. Feasibility 2. Service Engagement Scale --- Daily monitoring of well-being was initiated by pseudo-random mobile phone notifications to complete the EMPOWER questionnaire (see Report Supplementary Material 2). Notification reminders were sent after 5 minutes (when there had been no response), after which app users were allowed a 5-hour time window within which they could respond to questions. The questionnaire contains 22 items reflecting 13 domains (e.g. mood, anxiety, coping, psychotic experiences, self-esteem, connectedness to others, fear of relapse and personalised EWS). Items included both positive (e.g. ‘I’ve been feeling close to others’) and negative (e.g. ‘I’ve been worrying about relapse’) content. Each item was completed using a simple screen swipe, which enabled quick and efficient completion by users. Each item was automatically scored on a scale of 1–7. Where particular items scored > 3, users were invited to complete supplementary questions to enable a more fine-grained assessment of that domain. This provided up to a maximum of 56 questionnaire item Digital procedures The analysis and handling of questionnaire data was governed by the EMPOWER algorithm. The EMPOWER algorithm is a class 1 medical device (CI/2017/0039) that forms one part of a broader system that was designed to identify and respond to changes in well-being that were suggestive of EWS. Figure 2 provides a graphical representation of the system’s high-level components and data flow. Participants used a mobile phone app that prompted them to answer a daily questionnaire about the potential EWS of psychosis. The data were then submitted to the EMPOWER server and analysed by the ChIP algorithm. The algorithm, which is summarised in Figure 3, compared a participant’s latest data entry against their personal baseline. If changes exceeded predefined thresholds, a ChIP was generated for the participant. The consequences of the ChIP were that the research team, which included a registered mental health nurse (in the UK), clinical psychologists (in the UK and Australia) and a general psychologist (in Australia only), were e-mailed about the participant and that participant’s status was set to ‘alert’ and was highly visible on a secure web-based researcher interface. In addition to viewing and handling ChIPs, researchers could view longitudinal graphs of their participants’ well- being and possible EWS, filtered by question or by domain (group of questions). ChIPs were initially screened by a member of the research team, followed by (1), in Australia, sharing a summary of relevant ChIP data with the clinical team, and (2), in the UK, a member of the research team checking in with the participant. Based on the outcome of this triage assessment the researcher could share an update with the participant’s care co-ordinator, who could, if indicated, escalate increased support to the participant from their local CMHS to reduce risk of relapse. We aimed to respond to ChIPs in some way within 24 hours or the next working day. The alert algorithm also ran a separate process scanning for EWS changes against the baseline. Based on these changes, the logic selected a message from the most appropriate of several content-based message pools (i.e. one message pool contained helpful messages about ‘mood’, another had messages about ‘anxiety and coping’, etc.). This message was delivered back to, and displayed on, the participant’s EMPOWER app. Messages were intended to help people have a greater sense of control over their mental health and well-being and to support self-management. We set up a specific patient and public involvement group to assist us in the co-design of the message function in the app. The group advised on the curation, content and delivery of messages. This group met on four occasions and had public representation from four people with direct lived experience of psychosis. ![[Screenshot 2023-02-06 at 8.42.06 AM.png]] What is "small change" and "larger change?"?