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

Официальное название

Enhancing Psychological Wellbeing and the Patient-caregiver Relationship Through Dyadic Mindfulness: A Randomized Controlled Trial in People With Parkinson's Disease and Their Caregivers

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Negative emotions [Срок оценки: 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).]

Вторичные конечные точки (6)

• Patient-caregiver relationship [Срок оценки: 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).]
• Mindfulness [Срок оценки: 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).]
• HRQOL [Срок оценки: 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).]
• Gut microbiome [Срок оценки: 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).]
• PD-related motor and non-motor symptoms [Срок оценки: 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).]
• Caregiving burden [Срок оценки: 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).]

Критерии участия

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 ≥18 years

Inclusion Criteria of caregivers of PwPD:

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

Either patient or caregiver needs to 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)

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Гонконг · 1 центр

• School of Nursing, The University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT06821230 · 17605424

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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