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

NCT ID: NCT06821230

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2027-06-30

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Dyadic mindfulness group

Group Type: EXPERIMENTAL

Dyadic mindfulness

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dyadic 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Grants Council, Hong Kong

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Kwok Yan Yan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Nursing, The University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Jojo Yan Yan Kwok

Role: CONTACT

jojoyyk@hku.hk

852 39176644

Facility Contacts

Jojo Yan Yan Kwok

Role: primary

jojoyyk@hku.hk

+852 39176644

Other Identifiers

17605424

Identifier Type: -

Identifier Source: org_study_id