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临床试验/NCT04548089
NCT04548089Unknown不适用

Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) - Empowering Resilience and Holistic Wellbeing for Sustaining Family Caregiving: A Waitlist Randomized Controlled Trial

Nanyang Technological University6 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2019年10月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
102
试验地点
6
主要终点
Change in scores on Caregiver Distress (HADS) from baseline

研究概览

简要总结

The current study builds on the empirical foundation of Mindful-Compassion Art Therapy (MCAT) to test its efficacy as a multicomponent, holistic, psycho-socio-spiritual intervention for supporting dementia family caregivers. MCAT is a group-based intervention that integrates mindfulness meditation and art therapy, with reflective awareness complementing emotional expression, to foster self-compassion and inner-resilience among professional caregivers. A wait-list RCT design is adopted to refine and extend the application of MCAT to empower self-care and resilience among 102 dementia family caregivers recruited via community-based dementia-care organizations in Singapore. The expected outcomes will advance theory and practice for sustainable dementia family caregiving in Singapore and around the globe.

详细描述

Background: Dementia is a neurodegenerative disease that leads to irreversible decline in one's cognitive and functional capacity, identity, and personhood. In Singapore, the number of persons with dementia is expected to soar to 187,000 by 2050. Hence, it is imperative to render comprehensive support to dementia sufferers, and especially their family caregivers. While local initiatives have raised public awareness and developed services for dementia care, they do not adequately address the psycho-socio-spiritual needs of family caregivers, as caregiving stress can greatly impede one's mental and emotional health. International research for dementia family caregivers has thus focused on developing multicomponent interventions that accentuate holistic support to promote healthy and sustainable caregiving.

Objective and Methods: Building on the established MCAT protocol (Ho et al., 2019), this study will adopt a wait-list randomized controlled trial design to test the efficacy of the refined version of Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) among 102 dementia family caregivers in Singapore. This study aims to: 1) develop a disease-specific version of MCAT for Dementia Care (MCAT-DC); 2) assess MCAT-DC's effectiveness in reducing caregiver stress and burden; 3) assess MCAT-DC's effectiveness for reducing caregivers' depressive symptoms and psychophysiological distress, while enhancing resilience, hope, spirituality, meaning and quality-of-life; and 4) assess the feasibility and acceptability of a standardized MCAT-DC protocol for large-scale implementation.

Significance: MCAT is an effective psycho-social-spiritual intervention for reducing stress and promoting holistic wellbeing among professional caregivers. It has received wide recognition and distinction among palliative care and research communities for its clinical innovation and effectiveness. Given the robust evidence on MCAT's positive impact on professional caregivers, it is anticipated that a refined version of MCAT will have similar, if not greater, benefits for family caregivers. The study findings will form new knowledge to advance both theory and practice for sustainable dementia family caregiving in Singapore and around the globe.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informal caregiver of a family member with diagnosed with dementia
  • Fluent in written and verbal english

排除标准

  • Unable to provide informed consent
  • Diagnosed with major mental conditions or cognitive impairment

结局指标

主要结局

Change in scores on Caregiver Distress (HADS) from baseline

时间窗: Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].

Caregiver Distress is assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item scale that evaluates levels of anxiety and depression (Zigmond \& Snaith, 1983; Snaith, 2003)

Change in scores on Caregiver Burden (ZBI-12) from baseline

时间窗: Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].

Caregiver burden is assessed by the Zarit Burden Interview-Short (ZBI-12), a 12-item self-reported questionnaire comprising of three subscales of role-strain, self-criticism, and negative emotions (Tang et al., 2016).

次要结局

  • Change in scores on Support with Grief (ISS) from baseline(Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].)
  • Change in scores on Depressive Symptoms (PHQ-4) from baseline(Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].)
  • Change in scores on Resilience (ER89-R) from baseline(Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].)
  • Change in scores on Quality of Life (WHOQoL-8) from baseline(Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].)
  • Change in scores on Spirituality (FACIT-Sp) from baseline(Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].)
  • Change in scores on Hope (HHI) from baseline(Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andy Hau Yan Ho, PhD, EdD

Principal Investigator

Nanyang Technological University

研究点 (6)

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