Smartphone-Enhanced Symptom Management In Psychosis: An Open, Randomized Controlled Trial

Background: Improving recovery from acute symptoms and preventing relapse are two major challenges in serious mental illness. We developed a smartphone-based personalised technology to monitor symptoms in real time with good acceptability, reliability and validity. Objective: To 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. Methods: The active symptom monitoring smartphone 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 SMI. We conducted an open randomised controlled trial of active symptom monitoring (ASM) compared to usual management with the aim of assessing: (i) acceptability of continuous monitoring over 3 months; (ii) feasibility of detecting early warning signs of relapse; (iii) impact of active self-monitoring on positive psychotic symptoms assessed at 6 and 12 weeks. Eligible participants with a DSM4 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. Results: Of 181 eligible, 81 (45%) consented and were randomised to either active symptom monitoring or management as usual. Of those in the ASM, 90% continued to use the system at the 12 week follow up. Adherence, defined as responding to >33% of alerts, was 84%. At 12 weeks, ASM compared to usual management was associated with no difference on the empowerment scale. Although the primary outcome (positive symptom score on the PANSS scale) was not significant, the pre-planned intent-to-treat analysis of this outcome showed a significant reduction only in the ASM group over 12 weeks in the early intervention centre. Alerts for personalised early warning sign of relapse were able to be built into the workflows of the two 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. Conclusions: The active smartphone monitoring system is feasible and acceptable over three months to users with SMI, with surprisingly high levels of adherence. It 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 personalised alerts of symptom deterioration, it was shown to have potential use in promoting earlier intervention for relapse. Clinical Trial: The trial was approved by the South Birmingham NHS Research Ethics Committee reference 14/WM/0045. The trial was registered with the National Institute of Health Research CRN portfolio: 16361, and ISRCTN 88145142.