Digital technology coupled with peer support and clinical triage appeared to be feasible, safe, and acceptable for preventing relapse among patients with schizophrenia, according to results of a study published in The Lancet Psychiatry.
The Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) study was a multicenter, 2 parallel group, feasibility cluster randomized controlled trial conducted at 2 centers in Australia and 6 in Scotland in 2018. Patients aged ≥16 years with schizophrenia were randomized to receive usual care (n=31) or a combined peer support, clinical triage, and digital technology intervention (n=42). The primary outcomes were feasibility, acceptability, and safety.
The digital intervention comprised the EMPOWER phone application which monitored daily changes in wellbeing and sent tailored messages based on patient input. For peer support, patients were encouraged to monitor their wellbeing and were contacted by telephone every 2 weeks by staff.
The intervention and control cohorts were 50% and 52% men, aged a mean of 42 (SD, 13) and 43 (SD, 12) years, and 48% and 39% were in full remission at baseline, respectively.
Among the EMPOWER group, 81% completed a 4-week baseline monitoring period and used the application for 31.5 weeks 4.5 days per week on average. The investigators observed, that although there was high engagement with the application, patients were less likely to share their data with caregivers or clinic staff.
Using an adapted Mobile Application Rating Scale user version (uMARs), the patients indicated the application was interesting to use (range, 3.52-3.93), easy to learn (range, 4.12-4.17), the content was well written (range, 4.04-4.13), and the content was credible (range, 4.45-4.57).
The application was associated with increased awareness (range, 3.97-4.46), knowledge (range, 3.76-4.19), better attitude (range, 3.72-4.04), motivation (range, 3.87-4.35), and they were encouraged seek help when needed (range, 4.09-4.14).
Patients who received the EMPOWER intervention had a decreased fear of relapse than the controls (mean difference [MD], -7.53; 95% CI, -14.45 to 0.60).
Adverse events occurred among 19 EMPOWER participants and 10 controls, in which 11 events were serious in the EMPOWER cohort and 15 in the control cohort. A total of 13 events among 11 patients were considered to be related to the intervention. One of the application-related events was serious, resulting in hospital admission due to feeling overwhelmed during the application installation process.
The major limitation of the EMPOWER intervention was that patients in the active treatment arm had higher attrition which could have been related to additional burden and adverse effects due to self-monitoring.
The study authors concluded, “We established the feasibility of a definitive randomized controlled trial and tested acceptability, usability, and safety of the EMPOWER intervention. […] Taken together, these results provide support for the feasibility, recruitment, and follow-up of service user participants in a future trial.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Gumley AI, Bradstreet S, Ainsworth J, et al. The EMPOWER blended digital intervention for relapse prevention in schizophrenia: a feasibility cluster randomised controlled trial in Scotland and Australia. Lancet Psychiatry. 2022;9(6):477-486. doi:10.1016/S2215-0366(22)00103-1