NCT06821230 Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers
| NCT ID | NCT06821230 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Mindfulness |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-02-11 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria of 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06821230 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mindfulness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06821230 currently recruiting?
Yes, NCT06821230 is actively recruiting participants. Contact the research team at jojoyyk@hku.hk for enrollment information.
Where is the NCT06821230 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06821230 clinical trial?
NCT06821230 is sponsored by The University of Hong Kong. The trial plans to enroll 200 participants.