Art therapy and music reminiscence activity in the prevention of cognitive decline: study protocol for a randomized controlled trial Page: 1
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Mahendran et al. Trials (2017) 18:324
DOI 10.1186/si13063-017-2080-7 Trials
STUDY PROTOCOL "penAcces
Art therapy and music reminiscence activity!CrossMark
in the prevention of cognitive decline:
study protocol for a randomized controlled
trial
Rathi Mahendran,2,B* , Iris Rawtaer1'2, Johnson Fam1'2, Jonathan Wong1, Alan Prem Kumar4'5'6'7, Mihir Gandhi8'9'10
Kenny Xu Jing8, Lei Feng1'2 and Ee Heok Kua1'2
Abstract
Background: Attention has shifted to the use of non-pharmacological interventions to prevent cognitive decline as
a preventive strategy, as well as for those at risk and those with mild cognitive impairment. Early introduction of
psycho-social interventions can address cognitive decline and significantly impact quality of life and the wellbeing
of elderly individuals. This pilot study explores the feasibility of using art therapy and music reminiscence activity to
improve the cognition of community living elderly with mild cognitive impairment.
Methods/Design: This open-label, interventional study involves a parallel randomized controlled trial design with
three arms (two intervention arms and a control group) over a nine-month period. Participants will be community-
living elderly individuals aged 60-85 years, both genders, who meet predefined inclusion and exclusion criteria. In
the initial three months, interventions will be provided weekly and for the remaining six months fortnightly. A
sample size of 90 participants is targeted based on expected neuropsychological test performance, a primary
outcome measure, and drop-out rates. The randomization procedure will be carried out via a web-based
randomization system. Interventions will be provided by trained staff with a control group not receiving any
intervention but continuing life as usual. Assessments will be done at baseline, three months, and nine months, and
include neuroimaging to measure cerebral changes and neuropsychological tests to measure for changes in
cognition. Secondary outcome measures will include mood changes in anxiety and depression and telomere
lengths. Statistical analysis will be undertaken by statisticians; all efficacy analysis will be carried out on an intention-
to-treat basis. Primary and secondary outcomes will be modeled using the linear mixed model for repeated
measurements and further analysis may be undertaken to adjust for potential confounders.
Discussion: This will be the first study to compare the effectiveness of art therapy and music reminiscence activity
in a randomized controlled trial. We expect that the trial will provide useful evidence for developing psychosocial
interventions for the elderly with mild cognitive impairment.
Trial registration: The study was registered on 7 July 2016 at Clinical Trials.gov, a service of the US National
Institute of Health (NCT02854085), retrospectively.
Keywords: Art therapy, Music reminiscence activity, Mild cognitive impairment, Randomized controlled trial
* Correspondence: medrm@nus.edu.sg
'Department of Psychological Medicine, Yong Loo Lin School of Medicine,
National University of Singapore, Singapore, Republic of Singapore
2Department of Psychological Medicine, National University Hospital, Tower
Block, Level 9, 1 E Kent Ridge Road, Singapore, Republic of Singapore
Full list of author information is available at the end of the articleQ The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
Bio~lled Central International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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Mahendran, Rathi; Rawtaer, Iris; Fam, Johnson; Wong, Jonathan; Kumar, Alan Prem; Gandhi, Mihir et al. Art therapy and music reminiscence activity in the prevention of cognitive decline: study protocol for a randomized controlled trial, article, July 12, 2017; London, United Kingdom. (https://digital.library.unt.edu/ark:/67531/metadc987446/m1/1/: accessed April 25, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT College of Science.