You selected:'No' -Are the participants in your study randomised to different groups? 'No' -Does your study protocol demand changing treatment/ patient care from accepted standards for any of the patients involved? 'No' -Are your findings going to be generalisable? Your study would NOT be considered Research by the NHS.You may still need other approvals.Researchers requiring further advice (e.g. those not confident with the outcome of this tool) should contact their R&D office or sponsor in the first instance, or the HRA to discuss your study. If contacting the HRA for advice, do this by sending an outline of the project (maximum one page), summarising its purpose, methodology, type of participant and planned location as well as a copy of this results page and a summary of the aspects of the decision(s) that you need further advice on to the HRA Queries
BACKGROUND There is growing evidence highlighting a significant gap between mental health and wellbeing needs and available support. Digital interventions, such as mental health apps, have been identified as an appropriate medium for addressing the problem. However, a number of apps are being developed and made available without the relevant evidence base. Thus, there is a need to conduct user testing and early evaluations of new apps to provide sufficient information for users and prescribers. OBJECTIVE The primary aim of this feasibility study is to describe the acceptability, engagement, and preliminary outcomes of using an app (Paradym) designed to promote emotional wellbeing and positive mental health. METHODS This is a mixed methods single-arm study with a pre- and post- design, aggregate with digital analytics data. We anonymously collected real world data on demographics, mental health and wellbeing, and usability and acceptance using validated questionnaires and open ended-questions. Participants were asked to download the app and use the intervention for a minimum of 2 weeks before completing follow up measures. Google Analytics was used to record levels of engagement with the app. Chi Square and t-tests were conducted to analyze quantitative data, and a thematic analysis approach was adopted for qualitative data. RESULTS A total of 116 participants accessed the study, of which 91 users downloaded the app. The sample was diverse in terms of ethnicity (43.5% belonging to minority ethnic groups) and included majority females (67.24%) between the ages 18-25 from the USA. Participants who completed the study (n=34) provided favorable feedback in terms of the app’s content, functionality and underlying principles. Although usability feedback varied across items, a high percentage of participants found that the app was easy to use. Based on descriptive data, the mean mental health and wellbeing scores improved. Post hoc analyses indicated that the reduction in PHQ-9 depression scores (t33 = -2.16) and the change in scores on one of the wellbeing measures (WHO-5) (t33 = 2.87) were statistically significant. No adverse events were reported and anxiety levels of the participants were found to be mild during the intervention period. CONCLUSIONS The findings of this study are encouraging and potentially show preliminary evidence of effectiveness. The findings also suggest scope for further research with underrepresented groups, such as ethnic minority populations. Furthermore, the research provides valuable information for future app upgrades and further evaluations of the intervention. CLINICALTRIAL Eisenstadt A, Liverpool S. User Testing Service Evaluation. doi:10.17605/OSF.IO/TVJBA.
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