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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.

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

BMC Complementary Medicine and Therapies July 17, 2023 DOI: 10.1186/s12906-023-04049-x (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Qualitative Peer reviewed
Sample size 168
Population Patients with Parkinson's disease from community settings and outpatient clinics
Interventions Meditation Yoga
Duration 8-week intervention, 24-week follow-up
Topics Anxiety Depression Meditation
Keywords Chronic illness care Parkinson’s disease Psychological distress Quality of life Rehabilitation Yoga
Citations 6
Key findings The trial will investigate whether individual mindfulness techniques (meditation or yoga) reduce anxiety and depression in Parkinson's disease patients compared to usual care.

Abstract

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. 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. 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. WHO Primary Registry - Chinese Clinical Trials Registry number: ChiCTR2100045939; registered on 2021/04/29 ( https://www.chictr.org.cn/showproj.html?proj=125878 ).

Comparable studies

Other randomized controlled trials on anxiety, most cited first.

Study Year Design Participants
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety 2016 Randomized controlled trial n = 51
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance Hallucinogen-naïve adults reporting regular participation in religious or spiritual... 2006 Double-blind study n = 36
Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer Adults with advanced-stage cancer and anxiety 2010 Double-blind, placebo-controlled study n = 12

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