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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.

BMC complementary medicine and therapies
January 1, 1970
Jojo Yan Yan Kwok et al. (10 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to investigate the effects and mechanisms of individual mindfulness techniques (meditation and yoga) on anxiety, depression, and symptom management in Parkinson's disease patients.

Results Summary

The study will evaluate primary outcomes (anxiety and depression) and secondary outcomes (motor/non-motor symptoms, quality of life, mindfulness levels, and stress/inflammatory biomarkers) at baseline, 8 weeks, and 24 weeks, but results are not yet reported in the abstract.

Population

Parkinson's disease patients (n=168) recruited from community settings and outpatient clinics.

Effective Dosage

90-minute weekly sessions of meditation or yoga for 8 weeks.

Duration

8 weeks (with follow-up at 24 weeks).

Interactions

None mentioned

Extracted Claims (14)
InterventionDirectionEndpointPopulationDosageImpactClaim #
meditation
neutral
anxiety and depression
PD patients
-
investigate the effects
#1
yoga
neutral
anxiety and depression
PD patients
-
investigate the effects
#2
meditation
neutral
PD-related motor and non-motor symptoms
PD patients
-
investigate the effects
#3
yoga
neutral
PD-related motor and non-motor symptoms
PD patients
-
investigate the effects
#4
meditation
neutral
quality-of-life
PD patients
-
investigate the effects
#5
yoga
neutral
quality-of-life
PD patients
-
investigate the effects
#6
meditation
neutral
level of mindfulness
PD patients
-
measured as mediating variables
#7
yoga
neutral
level of mindfulness
PD patients
-
measured as mediating variables
#8
meditation
neutral
biomarkers of stress
PD patients
-
measured as mediating variables
#9
yoga
neutral
biomarkers of stress
PD patients
-
measured as mediating variables
#10
meditation
neutral
inflammatory responses
PD patients
-
measured as mediating variables
#11
yoga
neutral
inflammatory responses
PD patients
-
measured as mediating variables
#12
individual mindfulness techniques
neutral
stress and symptom management
PD patients
-
exploring participants' experience in using
#13
mindfulness practices
neutral
-
chronically ill patients
-
urged the implementation
#14
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 ).

Medical Subject Headings (MeSH)
United StatesHumansYogaMeditationDepressionParkinson DiseaseMindfulnessAnxietyRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations3
Citations/Year1.5
Relative Citation Ratio1.14
NIH Percentile55%
Research Impact Scores
APT Score0.50
Weight Score1.58
Normalized Score0.67
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