Protocol for a mixed-methods randomised controlled trial evaluating the psychosocial effects of an expressive arts-based intervention on adults with age-related macular degeneration

BMJ Open. 2024 Dec 20;14(12):e088311. doi: 10.1136/bmjopen-2024-088311.

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: NCT05675150, prospectively registered.

Keywords: GERIATRIC MEDICINE; OPHTHALMOLOGY; Randomized Controlled Trial.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Aged
  • Art Therapy* / methods
  • Female
  • Humans
  • Macular Degeneration* / psychology
  • Macular Degeneration* / therapy
  • Male
  • Middle Aged
  • Quality of Life
  • Randomized Controlled Trials as Topic

Associated data

  • ClinicalTrials.gov/NCT05675150