Ho, Rainbow Tin HungRainbow Tin HungHoCheong, Allen Ming YanAllen Ming YanCheongWan, Adrian Ho YinAdrian Ho YinWanLo, Lee Ting TemmyLee Ting TemmyLoFong, Ted Chun TatTed Chun TatFongDr. CHAN Kar-pui, CaitlinCaitlinDr. CHAN Kar-puiLi, QingQingLiLi, Wai ChinWai ChinLi2026-06-222026-06-222024BMJ Open, 2024, vol. 14(12), article no. e088311.2044-6055http://hdl.handle.net/20.500.11861/27617Open access<jats:sec> <jats:title>Introduction</jats:title> <jats:p>Age-related macular degeneration (AMD) is a prevalent eye disease among middle-aged and older adults. AMD leaves the patient with irreversible deteriorating vision, which profoundly impacts their daily lives and psychosocial well-being. Given the limited studies addressing the psychosocial needs of adults with AMD and, in particular, using an expressive arts-based intervention (EXABI) as an intervention, this study aims to investigate the effectiveness of such an intervention in enhancing the psychosocial well-being of adults with AMD.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and analysis</jats:title> <jats:p> This study will employ a mixed-methods randomised controlled trial design. One hundred fifty-four participants with AMD will be recruited and randomised into either the EXABI or treatment-as-usual waitlist control group. Participants will respond to a battery of measurements regarding their psychosocial condition at four time points: baseline (T <jats:sub>0</jats:sub> ), 2 months after baseline (postintervention, T <jats:sub>1</jats:sub> ), 5 months after baseline (T <jats:sub>2</jats:sub> ) and 8 months after baseline (T <jats:sub>3</jats:sub> ). A subgroup of participants will also share their experiences through in-depth interviews at T <jats:sub>1</jats:sub> and T <jats:sub>3</jats:sub> to help further understand the mechanism and effect of the intervention. Quantitative data will be analysed by mixed-effects models and path analysis, whereas qualitative data will be analysed by adopting the thematic analysis approach. The two sets of data will be integrated to provide a comprehensive view of the effectiveness and mechanisms of the intervention. </jats:p> </jats:sec> <jats:sec> <jats:title>Ethics and dissemination</jats:title> <jats:p>This study has obtained ethical approval from the Human Research Ethics Committee of the University of Hong Kong (Ref. no.: EA210606). All research procedures will be conducted upon receiving signed written consent forms from participants. The findings of the study will also be presented at international conferences and published in peer-reviewed academic journals.</jats:p> </jats:sec> <jats:sec> <jats:title>Trial registration number</jats:title> <jats:p> <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT05675150">NCT05675150</jats:ext-link> , prospectively registered. </jats:p> </jats:sec>enProtocol for a mixed-methods randomised controlled trial evaluating the psychosocial effects of an expressive arts-based intervention on adults with age-related macular degenerationPeer Reviewed Journal Article10.1136/bmjopen-2024-088311