Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers
Recruiting now · Not applicable
Conditions studied: Mindfulness, Caregivers, Movement Disorders, Neurodegenerative Disease, Dyadic Intervention, Psychosocial Health, Parkinsons Disease
In brief
The proposed two-arm randomized waitlist-controlled trial will use a mixed-methods design to investigate the effects of dyadic mindfulness on physio-psycho-spiritual outcomes in people with Parkinson's Disease (PwPD) and their family caregivers. One hundred Chinese patient-caregiver dyads will be randomized to receive eight weekly 90-minute dyadic mindfulness sessions or usual care. Outcome measures include negative emotions (primary outcome), patient-caregiver relationship, mindfulness, HRQOL, gut microbiome, PD-related symptoms, and caregiving burden. An actor-partner interdependence model will be used to explore the interactions of treatment effects within the dyads. The dyads will be assessed at baseline(T0), post-intervention(T1), and 4-months post-intervention(T2). The investigators will also invite 25 dyads to attend in-depth interviews exploring their experiences, perceived changes, and factors attributable to the effectiveness/ineffectiveness of the intervention. Generalized linear mixed-effects (GLME) with intention-to-treat analysis will be used to compare the changes in outcomes over time within and between the two arms. The findings will be triangulated to provide a comprehensive evaluation of the intervention's effectiveness. This study will generate rigorous scientific evidence to inform the application of dyadic mindfulness as a public health practice preventing the progression of psychological distress in PwPD and caregivers to clinically severe levels. Its self-help nature also enriches the primary care for this clinical cohort.
Key facts
- Study ID
- NCT06821230
- Run by
- The University of Hong Kong
- People needed
- 200
- Starts
- 2025-02-11
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-06-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Engage in regular supervised mind-body practices such as Tai Chi, yoga, or other forms of mindfulness training (>2 times per week)
- Have a pre-existing acute psychotic disease
- Currently participating in any other behavioral or pharmacological trial
- Have significant cognitive impairment, as indicated by an Abbreviated Mental Test score≤ 6
- Have other contraindications that may limit their full participation (e.g., severe hearing/vision impairment)
Where it is running
- School of Nursing, The University of Hong Kong — Hong Kong, Hong Kong (enrolling)
Full record on ClinicalTrials.gov
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