Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers

The University of Hong Kong200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

200

Conditions

Interventions

Dyadic mindfulnessBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Negative emotions

Negative emotions (primary outcome) will be measured by validated Chinese DASS-21 using a one-week recall period, which was developed to measure three related and clinically significant negative emotional states of depression, anxiety and stress. Each item is rated on a 0-3 scale (0="Did not apply to me at all" to 3="Applied to me very much or most of the time"). The score of each subscale ranges from 0-42 and the total score ranges from 0-126, with higher score indicating greater self-reported levels of depression, anxiety and stress.