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BackgroundMobile phone–based assessment may represent a cost-effective and clinically effective method of monitoring psychotic symptoms in real-time. There are several software options, including the use of native smartphone applications and text messages (short message service, SMS). Little is known about the strengths and limitations of these two approaches in monitoring symptoms in individuals with serious mental illness. ObjectiveThe objective of this study was to compare two different delivery modalities of the same diagnostic assessment for individuals with non-affective psychosis—a native smartphone application employing a graphical, touch user interface against an SMS text-only implementation. The overall hypothesis of the study was that patient participants with sewrious mental illness would find both delivery modalities feasible and acceptable to use, measured by the quantitative post-assessment feedback questionnaire scores, the number of data points completed, and the time taken to complete the assessment. It was also predicted that a native smartphone application would (1) yield a greater number of data points, (2) take less time, and (3) be more positively appraised by patient participant users than the text-based system. MethodsA randomized repeated measures crossover design was employed. Participants with currently treated Diagnostic and Statistical Manual (Fourth Edition) schizophrenia or related disorders (n=24) were randomly allocated to completing 6 days of assessment (four sets of questions per day) with a native smartphone application or the SMS text-only implementation. There was then a 1-week break before completing a further 6 days with the alternative delivery modality. Quantitative feedback questionnaires were administered at the end of each period of sampling. ResultsA greater proportion of data points were completed with the native smartphone application in comparison to the SMS text-only implementation (β = -.25, SE=.11, P=.02), which also took significantly less time to complete (β =.78, SE= .09, P

BackgroundImproving recovery from acute symptoms and preventing relapse are two significant challenges in severe mental illness. We developed a personalized smartphone-based app to monitor symptoms in real time and validated its acceptance, reliability, and validity. ObjectiveTo assess (i) acceptability of continuous monitoring to SMI patients and health professionals over 3 months; (ii) impact of active self-monitoring on positive psychotic symptoms assessed at 6 and 12 weeks; and (iii) the feasibility of detecting early warning signs of relapse. MethodsThe active symptom monitoring smartphone app was built into an end-to-end system in two NHS Trusts to enable real-time symptom self-monitoring and detection by the clinical team of early signs of relapse in people with severe mental illness. We conducted an open randomized controlled trial of active symptom monitoring compared to usual management to assess: (i) acceptability and safety of continuous monitoring over 3 months; (ii) impact of active self-monitoring on positive psychotic symptoms assessed at 6 and 12 weeks; (iii) feasibility of detecting early warning signs of relapse communicated to the healthcare staff via an app streaming data to the electronic health record. Eligible participants with a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of schizophrenia and related disorders, and a history of relapse within the previous two years were enrolled from an early intervention team and a community mental health team. ResultsOf 181 eligible patients, 81 (45%) consented and were randomized to either active symptom monitoring or management as usual. At 12 weeks, 90% (33/36) of those in the active monitoring group continued to use the system and exhibited an adherence rate (defined as responding to >33% of alerts) of 84% (30/36}. Active symptom monitoring was associated with no difference on the empowerment scale in comparison to the usual management group at 12 weeks. The pre-planned intent-to-treat analysis of the primary outcome, a positive score on the Positive and Negative Syndrome Scale (PANSS) scale, showed a significant reduction in the active symptom monitoring group over 12 weeks in the early intervention center. Alerts for personalized early warning signs of relapse were built into the workflows of both NHS Trusts, and 100% of health professional staff used the system in a new digital workflow. Qualitative analyses supported the acceptability of the system to participants and staff. ConclusionsThe active smartphone monitoring system is feasible and was accepted by users in a 3-month study of people with severe mental illness, with surprisingly high levels of adherence. App use was associated with psychotic symptom improvement in recent-onset participants, but not those with longstanding illness, supporting the notion of improved self-management. When built into clinical management workflows to enable personalized alerts of symptom deterioration, the app has demonstrated utility in promoting earlier intervention for relapse. Trial RegistrationISRCTN Registry ISRCTN88145142; http://www.isrctn.com/ISRCTN88145142

BackgroundRelapse 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. ObjectiveThis 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. MethodsWe 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. ResultsRecruitment 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. ConclusionsThe 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 RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262 International Registered Report Identifier (IRRID)DERR1-10.2196/15058

Background: Psychosis is one of the most disabling mental health conditions and causes significant personal, social, and economic burden. Accurate and timely symptom monitoring is critical to offering prompt and time-sensitive clinical services. Digital health is a promising solution for the barriers encountered by conventional symptom monitoring approaches, including accessibility, the ecological validity of assessments, and recall bias. However, to date, there has been no digital health technology developed to support self-management for people with psychosis in China., Objective: We report the study protocol to evaluate the validity, feasibility, acceptability, usability, and safety of a symptom self-monitoring smartphone app (YouXin; Chinese name ) for people with psychosis in China., Methods: This is a nonrandomized validity and feasibility study with a mixed methods design. The study was approved by the University of Manchester and Beijing Anding Hospital Research Ethics Committee. YouXin is a smartphone app designed to facilitate symptom self-monitoring for people with psychosis. YouXin has 2 core functions: active monitoring of symptoms (ie, smartphone survey) and passive monitoring of behavioral activity (ie, passive data collection via embedded smartphone sensors). The development process of YouXin utilized a systematic coproduction approach. A series of coproduction consultation meetings was conducted by the principal researcher with service users and clinicians to maximize the usability and acceptability of the app for end users. Participants with psychosis aged 16 years to 65 years were recruited from Beijing Anding Hospital, Beijing, China. All participants were invited to use the YouXin app to self-monitor symptoms for 4 weeks. At the end of the 4-week follow-up, we invited participants to take part in a qualitative interview to explore the acceptability of the app and trial procedures postintervention., Results: Recruitment to the study was initiated in August 2022. Of the 47 participants who were approached for the study from August 2022 to October 2022, 41 participants agreed to take part in the study. We excluded 1 of the 41 participants for not meeting the inclusion criteria, leaving a total of 40 participants who began the study. As of December 2022, 40 participants had completed the study, and the recruitment was complete., Conclusions: This study is the first to develop and test a symptom self-monitoring app specifically designed for people with psychosis in China. If the study shows the feasibility of YouXin, a potential future direction is to integrate the app into clinical workflows to facilitate digital mental health care for people with psychosis in China. This study will inform improvements to the app, trial procedures, and implementation strategies with this population. Moreover, the findings of this trial could lead to optimization of digital health technologies designed for people with psychosis in China., International Registered Report Identifier (irrid): DERR1-10.2196/45170., (©Xiaolong Zhang, Shôn Lewis, Lesley-Anne Carter, Sandra Bucci. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 12.09.2023.)