A randomized controlled trial on the effects and acceptability of individual mindfulness techniques – meditation and yoga – on anxiety and depression in people with Parkinson’s disease: a study protocol

Abstract Background Between 40 and 50% of patients with Parkinson’s disease (PD) experience anxiety and depression, associated with impaired physical function, high care dependency and mortality. Recently, the United States National Institutes of Health has urged the implementation of mindfulness pr...

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Main Authors: Jojo Yan Yan Kwok, Man Auyeung, Shirley Yin Yu Pang, Philip Wing Lok Ho, Doris Sau Fung Yu, Daniel Yee Tak Fong, Chia-chin Lin, Richard Walker, Samuel Yeung-shan Wong, Rainbow Tin Hung Ho
Format: Article
Language:English
Published: BMC 2023-07-01
Series:BMC Complementary Medicine and Therapies
Subjects:
Online Access:https://doi.org/10.1186/s12906-023-04049-x
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author Jojo Yan Yan Kwok
Man Auyeung
Shirley Yin Yu Pang
Philip Wing Lok Ho
Doris Sau Fung Yu
Daniel Yee Tak Fong
Chia-chin Lin
Richard Walker
Samuel Yeung-shan Wong
Rainbow Tin Hung Ho
author_facet Jojo Yan Yan Kwok
Man Auyeung
Shirley Yin Yu Pang
Philip Wing Lok Ho
Doris Sau Fung Yu
Daniel Yee Tak Fong
Chia-chin Lin
Richard Walker
Samuel Yeung-shan Wong
Rainbow Tin Hung Ho
author_sort Jojo Yan Yan Kwok
collection DOAJ
description Abstract Background Between 40 and 50% of patients with Parkinson’s disease (PD) experience anxiety and depression, associated with impaired physical function, high care dependency and mortality. Recently, the United States National Institutes of Health has urged the implementation of mindfulness practices in chronic illness care. Most research to date has examined the effects on chronically ill patients of complex interventions using a combination of mindfulness techniques. In PD patients, however, such complex modalities appear to hinder the technique mastery. Hence, the aim of this trial is to investigate the effects and underlying mechanism of individual mindfulness techniques among PD patients, as well as exploring participants’ experience in using individual mindfulness techniques as a lifestyle intervention for stress and symptom management. Methods We will conduct an assessor-blind three-arm randomized waitlist-controlled trial with a descriptive qualitative evaluation. Up to 168 PD patients will be recruited from community settings and out-patient clinics, and randomized to meditation, yoga, or usual care group. Meditation and yoga sessions of 90-minute are held weekly for 8 weeks. Primary outcomes include anxiety and depression. Secondary outcomes include PD-related motor and non-motor symptoms and quality-of-life; and level of mindfulness and biomarkers of stress and inflammatory responses will be measured as mediating variables. All outcome evaluations will be assessed at baseline, 8 weeks, and 24 weeks. Following the intention-to-treat principle, generalized estimating equation models and path analysis will be used to identify the treatment effects and the mediating mechanisms. A subsample of 30 participants from each intervention group will be invited for qualitative interviews. Discussion The study would also generate important insights to enhance the patients’ adaptation to debilitating disease. More specifically, symptom management and stress adaptation are highly prioritized healthcare agenda in managing PD. The research evidence will further inform the development of community-based, nurse-led compassionate care models for neurodegenerative conditions, which is complementary to existing health services. Trial registration WHO Primary Registry – Chinese Clinical Trials Registry number: ChiCTR2100045939; registered on 2021/04/29 ( https://www.chictr.org.cn/showproj.html?proj=125878 ).
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spelling doaj.art-df6db1af18e842b7b54718866732c8db2023-07-23T11:06:40ZengBMCBMC Complementary Medicine and Therapies2662-76712023-07-0123111410.1186/s12906-023-04049-xA randomized controlled trial on the effects and acceptability of individual mindfulness techniques – meditation and yoga – on anxiety and depression in people with Parkinson’s disease: a study protocolJojo Yan Yan Kwok0Man Auyeung1Shirley Yin Yu Pang2Philip Wing Lok Ho3Doris Sau Fung Yu4Daniel Yee Tak Fong5Chia-chin Lin6Richard Walker7Samuel Yeung-shan Wong8Rainbow Tin Hung Ho9School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong KongDepartment of Medicine, Pamela Youde Nethersole Eastern HospitalDepartment of Medicine, Queen Mary HospitalDivision of Neurology, Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong KongSchool of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong KongSchool of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong KongSchool of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong KongNorthumbria Healthcare NHS Foundation Trust, North Tyneside General HospitalThe Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong KongCentre on Behavioral Health, The University of Hong KongAbstract Background Between 40 and 50% of patients with Parkinson’s disease (PD) experience anxiety and depression, associated with impaired physical function, high care dependency and mortality. Recently, the United States National Institutes of Health has urged the implementation of mindfulness practices in chronic illness care. Most research to date has examined the effects on chronically ill patients of complex interventions using a combination of mindfulness techniques. In PD patients, however, such complex modalities appear to hinder the technique mastery. Hence, the aim of this trial is to investigate the effects and underlying mechanism of individual mindfulness techniques among PD patients, as well as exploring participants’ experience in using individual mindfulness techniques as a lifestyle intervention for stress and symptom management. Methods We will conduct an assessor-blind three-arm randomized waitlist-controlled trial with a descriptive qualitative evaluation. Up to 168 PD patients will be recruited from community settings and out-patient clinics, and randomized to meditation, yoga, or usual care group. Meditation and yoga sessions of 90-minute are held weekly for 8 weeks. Primary outcomes include anxiety and depression. Secondary outcomes include PD-related motor and non-motor symptoms and quality-of-life; and level of mindfulness and biomarkers of stress and inflammatory responses will be measured as mediating variables. All outcome evaluations will be assessed at baseline, 8 weeks, and 24 weeks. Following the intention-to-treat principle, generalized estimating equation models and path analysis will be used to identify the treatment effects and the mediating mechanisms. A subsample of 30 participants from each intervention group will be invited for qualitative interviews. Discussion The study would also generate important insights to enhance the patients’ adaptation to debilitating disease. More specifically, symptom management and stress adaptation are highly prioritized healthcare agenda in managing PD. The research evidence will further inform the development of community-based, nurse-led compassionate care models for neurodegenerative conditions, which is complementary to existing health services. Trial registration WHO Primary Registry – Chinese Clinical Trials Registry number: ChiCTR2100045939; registered on 2021/04/29 ( https://www.chictr.org.cn/showproj.html?proj=125878 ).https://doi.org/10.1186/s12906-023-04049-xMindfulnessPsychological distressAnxietyDepressionParkinson’s diseaseQuality of life
spellingShingle Jojo Yan Yan Kwok
Man Auyeung
Shirley Yin Yu Pang
Philip Wing Lok Ho
Doris Sau Fung Yu
Daniel Yee Tak Fong
Chia-chin Lin
Richard Walker
Samuel Yeung-shan Wong
Rainbow Tin Hung Ho
A randomized controlled trial on the effects and acceptability of individual mindfulness techniques – meditation and yoga – on anxiety and depression in people with Parkinson’s disease: a study protocol
BMC Complementary Medicine and Therapies
Mindfulness
Psychological distress
Anxiety
Depression
Parkinson’s disease
Quality of life
title A randomized controlled trial on the effects and acceptability of individual mindfulness techniques – meditation and yoga – on anxiety and depression in people with Parkinson’s disease: a study protocol
title_full A randomized controlled trial on the effects and acceptability of individual mindfulness techniques – meditation and yoga – on anxiety and depression in people with Parkinson’s disease: a study protocol
title_fullStr A randomized controlled trial on the effects and acceptability of individual mindfulness techniques – meditation and yoga – on anxiety and depression in people with Parkinson’s disease: a study protocol
title_full_unstemmed A randomized controlled trial on the effects and acceptability of individual mindfulness techniques – meditation and yoga – on anxiety and depression in people with Parkinson’s disease: a study protocol
title_short A randomized controlled trial on the effects and acceptability of individual mindfulness techniques – meditation and yoga – on anxiety and depression in people with Parkinson’s disease: a study protocol
title_sort randomized controlled trial on the effects and acceptability of individual mindfulness techniques meditation and yoga on anxiety and depression in people with parkinson s disease a study protocol
topic Mindfulness
Psychological distress
Anxiety
Depression
Parkinson’s disease
Quality of life
url https://doi.org/10.1186/s12906-023-04049-x
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