Protocol for a mixed-methods randomised controlled trial evaluating the psychosocial effects of an expressive...

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.

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 (T₀), 2 months after baseline (postintervention, T₁), 5 months after baseline (T₂) and 8 months after baseline (T₃). A subgroup of participants will also share their experiences through in-depth interviews at T₁ and T₃ 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.

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.

NCT05675150, prospectively registered.