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

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Psychosocial Health; Movement Disorders; Mindfulness; Dyadic Intervention; Parkinsons Disease; Neurodegenerative Disease; Caregivers

Treatments: Behavioral: Dyadic mindfulness

Study type: Interventional

Funder types: Other

Identifiers

NCT06821230

17605424

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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)

Inclusion Criteria of caregivers of PwPD:

• Self-identified as the primary caregivers of their patient

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Dyadic mindfulness group

Experimental group

Treatment:

Behavioral: Dyadic mindfulness

Wait-list usual care control group

No Intervention group

Description:

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.