Evaluating a mobile-based intervention to promote the mental health of informal dementia caregivers in Singapore: Study protocol for a pilot two-armed randomised controlled trial.

BackgroundInformal caregivers of persons with dementia (PWD) often suffer adverse impacts on their mental health and require interventions for effective support. As they are often occupied with providing care, web-based interventions could be more convenient and efficient for them. However, there is currently a dearth of evidence-based mobile interventions to enhance the mental well-being of dementia caregivers locally, especially ones that are user-centered and culturally relevant. Hence, having designed an app based on feedback from local dementia caregivers, this study will evaluate the effectiveness of this mobile app in promoting the mental health of informal caregivers of PWD in Singapore.MethodsA pilot two-armed randomised controlled trial will be conducted on 60 informal caregivers of PWD recruited via convenience and snowball sampling. Thirty participants will be assigned to the intervention group, while another 30 will be in a waiting-list control group. Questionnaires will be administered at baseline and one month after, with the primary outcome being the difference in the change of depressive symptoms among the two groups.Statistical analysisPrimary analyses will follow the intention-to-treat principle and compare changes from baseline to the one-month follow-up time point relative to the control group. A repeated measures ANOVA will be conducted to examine differences between the groups over time.SignificanceTo our knowledge, this is the first study in Singapore that seeks to promote the mental health of informal dementia caregivers through a mobile-based intervention. The findings can inform the development and evaluation of future evidence-based digital interventions for local informal caregivers of PWD to address the gap in availability of such resources for them.Trial registrationClinicalTrials.gov (NCT05551533). Registration date: September 22, 2022.