NCT06821230Recruiting
Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers
Enhancing Psychological Wellbeing and the Patient-caregiver Relationship Through Dyadic Mindfulness: A Randomized Controlled Trial in People With Parkinson's Disease and Their Caregivers
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 6 Feb 2025
- Start date
- 11 Feb 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- The University of Hong Kong
- Diseases
- Parkinson disease
- NCT number
- NCT06821230
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 11 Feb 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have a pre-existing acute psychotic disease
- 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)
Other
- Engage in regular supervised mind-body practices such as Tai Chi, yoga, or other forms of mindfulness training (\>2 times per week)
- Currently participating in any other behavioral or pharmacological trial
Who the study is looking for
- 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
- \- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| School of Nursing, The University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.