NCT06821230

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mindfulness
• Caregivers
• Movement Disorders
• Neurodegenerative Disease
• Dyadic Intervention
• Psychosocial Health
• Parkinsons Disease

Interventions

Type	Name	Description
BEHAVIORAL	Dyadic mindfulness	The dyadic mindfulness intervention group will receive 8 weekly 90-min sessions, with a total of 12 contact hours. The intervention will be delivered in a small group format with 6-8 dyads each and led by a certified yoga instructor with mindfulness qualifications. The program content mindfulness meditation, mindful breathing, and yoga sequences with warm-up and cool-down and each component is modified to pair-based practices.

Timeline

• Start date: 2025-02-11
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2025-02-11
• Last updated: 2026-03-20

Locations

1 site across 1 country: Hong Kong