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
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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 50-80

• 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)

⁃ \- Self-identified as the primary caregivers of their patient

⁃ Both need to be able to communicate in Cantonese and provide written consent.

Locations
Other Locations
Hong Kong Special Administrative Region
School of Nursing, The University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Jojo Yan Yan Kwok
jojoyyk@hku.hk
852 39176644
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Research Grants Council, Hong Kong
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov