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

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 psychosoc...

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Main Authors: Qing Li, Temmy Lee Ting Lo, Rainbow Tin Hung Ho, Adrian Ho Yin Wan, Ted Chun Tat Fong, Caitlin Kar Pui Chan, Allen Ming Yan Cheong, Wai Chi Chan
Format: Article
Language:English
Published: BMJ Publishing Group 2024-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/14/12/e088311.full
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author Qing Li
Temmy Lee Ting Lo
Rainbow Tin Hung Ho
Adrian Ho Yin Wan
Ted Chun Tat Fong
Caitlin Kar Pui Chan
Allen Ming Yan Cheong
Wai Chi Chan
author_facet Qing Li
Temmy Lee Ting Lo
Rainbow Tin Hung Ho
Adrian Ho Yin Wan
Ted Chun Tat Fong
Caitlin Kar Pui Chan
Allen Ming Yan Cheong
Wai Chi Chan
author_sort Qing Li
collection DOAJ
description 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.
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spelling doaj-art-971751e9550a4166ab6bea1d91f9343c2025-01-14T12:45:10ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-088311Protocol for a mixed-methods randomised controlled trial evaluating the psychosocial effects of an expressive arts-based intervention on adults with age-related macular degenerationQing Li0Temmy Lee Ting Lo1Rainbow Tin Hung Ho2Adrian Ho Yin Wan3Ted Chun Tat Fong4Caitlin Kar Pui Chan5Allen Ming Yan Cheong6Wai Chi Chan7Institute of Digestive Disease, Department of Medicine and Therapeutics, State Key Laboratory of Digestive Disease, Li Ka Shing Institute of Health Sciences, CUHK Shenzhen Research Institute, The Chinese University of Hong Kong, Hong Kong, China1 Centre on Behavioral Health, The University of Hong Kong, Hong Kong, China1 Centre on Behavioral Health, The University of Hong Kong, Hong Kong, China1 Centre on Behavioral Health, The University of Hong Kong, Hong Kong, China1 Centre on Behavioral Health, The University of Hong Kong, Hong Kong, China1 Centre on Behavioral Health, The University of Hong Kong, Hong Kong, China3 School of Optometry, The Hong Kong Polytechnic University, Hong Kong, China6 Department of Psychiatry, University of Hong Kong, Hong Kong, ChinaIntroduction 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.https://bmjopen.bmj.com/content/14/12/e088311.full
spellingShingle Qing Li
Temmy Lee Ting Lo
Rainbow Tin Hung Ho
Adrian Ho Yin Wan
Ted Chun Tat Fong
Caitlin Kar Pui Chan
Allen Ming Yan Cheong
Wai Chi Chan
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://bmjopen.bmj.com/content/14/12/e088311.full
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