RecruitingNot ApplicableNCT06821230

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


Sponsor

The University of Hong Kong

Enrollment

200 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a mindfulness program practiced together by patients with Parkinson's disease and their family caregivers (called dyadic mindfulness) can reduce emotional distress and improve wellbeing for both people. **You may be eligible if...** - You are a Chinese patient with mild to moderate Parkinson's disease (able to walk and stand unassisted), aged 50 to 80, AND experiencing at least mild depression, anxiety, or stress - OR you are the primary caregiver of that patient - Both patient and caregiver must be able to communicate in Cantonese and provide written consent **You may NOT be eligible if...** - You already practice supervised mindfulness or meditation regularly - The patient has significant cognitive impairment (dementia) - Either person has a serious psychiatric condition - Either person cannot communicate in Cantonese Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDyadic 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.


Locations(1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong

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NCT06821230


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