Clinical trial NCT06821230: Dyadic Mindfulness for People with Parkinson's Disease and Their Caregivers
Official title: Enhancing Psychological Wellbeing and the Patient-caregiver Relationship Through Dyadic Mindfulness: a Randomized Controlled Trial in People with Parkinson's Disease and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mindfulness
Caregivers
Movement Disorders
Neurodegenerative Disease
Dyadic Intervention
Psychosocial Health
Parkinsons Disease
Keywords: Parkinsons disease
Mindfulness
dyadic care
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Research Grants Council, Hong Kong
First posted: 2025-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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)

Primary outcomes:
measure: Negative emotions
timeFrame: 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).
Secondary outcomes:
measure: Patient-caregiver relationship
timeFrame: 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).
measure: Mindfulness
timeFrame: 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).
measure: HRQOL
timeFrame: 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).
measure: Gut microbiome
timeFrame: 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).
measure: PD-related motor and non-motor symptoms
timeFrame: 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).
measure: Caregiving burden
timeFrame: 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).
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
References: