Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers
Recruiting · NCT06821230 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- f PwPD:
- Chinese patients with idiopathic mild-moderate PD (as indicated by the Hoehn and Yahr Scale stages I-III: those with unilateral/bilateral symptoms, with/without postural instability who are able to walk/stand unassisted)
- Aged ≥18 years
- Inclusion Criteria of caregivers of PwPD:
- \- Self-identified as the primary caregivers of their patient
- Either patient or caregiver needs to experience at least mild negative emotions (as indicated by the 21-item Depression, Anxiety and Stress Scale \[DASS21\] score of Depression subscale ≥10, Anxiety subscale ≥8, or Stress subscale ≥15)
- Both need to be able to communicate in Cantonese and provide written consent.
Exclusion criteria
- 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
1 location listed.
- School of Nursing, The University of Hong Kong - Hong Kong, Hong Kong