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

Sponsor
The University of Hong Kong
Study ID
NCT06821230
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dyadic mindfulness — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Feb 11, 2025
Start date
Feb 11, 2025
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Dyadic mindfulness group
  • No Intervention: Wait-list usual care control group
    The wait-list, usual care control group will continue with routine outpatient services (medication follow-up care with minimal health education on disease management/drug care) and then receive dyadic mindfulness training after the 6-month study period.

Primary Outcome Measure

Negative emotions [ Time Frame: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months). ]

Central Contacts

Find similar trials

Nationwide
Parkinson's disease trialsNeurology trialsBrain disorders trials

Related Studies