跳至主要内容
临床试验/NCT02667782
NCT02667782已完成不适用

Use of a Mindfulness-based Intervention for Family Carers of People With Dementia in the Community: A Feasibility Study

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2016年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Change of Perceived Stress Scale (PSS)

研究概览

简要总结

The aim of this study is to examine which mindfulness-based intervention protocol, MBCT or MBSR, is more suited for use among local carers of people with dementia (PWD), as measured by better mental health outcomes in PWD such as reductions in stress and improvements in mental well-being.

详细描述

60 subjects will be recruited in the community and randomized into either the MBCT or MBSR group. Both MBSR and MBCT will be delivered through a face-to-face teaching session followed by regular telephone follow-ups.

The primary outcome measures of the dementia caregivers will be stress with Perceived Stress Scale (PSS; Cohen & Williamson, 1988). The secondary outcome measures of the dementia caregiver will be 1) anxiety with Hospital Anxiety and Depression Scale (HADS; Zigmon & Snaith, 1983), 2) depression with Center for Epidemiologic Studies Depression Scale (CESD; Radloff, 1977), and 3) burden with Zarit Burden Inventory (ZBI; Zarit, Reever, & Bach-Peterson, 1980). The control measure will be their level of mastery of the five facets mindfulness with Five Facets Mindfulness Questionnaire (FFMQ; Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006). Focus group interviews with each group of participants will be conducted post-intervention to explore their experiences and perceptions.

Data will be collected at baseline (T0), at 2 months (the mid-point of the intervention; T1), 4 months (immediately after the intervention; T2), and 7 months (the follow-up assessment; T3). Adherence rates, response rates, and drop-out rates will be collected and analyzed. The triangulation of both qualitative and quantitative data will be performed to determine the suitability and benefits of MBSR and MBCT for carers of PWD in the local setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • has a major active psychiatric illness such as bipolar disorder or schizophrenia.
  • is currently undergoing cancer treatment.
  • has severe chronic pain (lasting more than six months).

研究组 & 干预措施

Mindfulness-Based Stress Reduction

Experimental

Mindfulness-Based Stress Reduction (MBSR) is developed by Jon Kabat-Zinn in 1979 (Kabat-Zinn, 1990). It is an eight-week Program that includes practices such as gentle mindful movement (awareness of the body), a body scan (to systematically nurture awareness of the body region by region), and sitting meditation (awareness of the breath to include the four foundations of mindfulness, namely, body, feeling tone, mental state, and mental content) (Cullen, 2011).

干预措施: Mindfulness-Based Stress Reduction (MBSR) (Behavioral)

Mindfulness-Based Cognitive Therapy

Experimental

Mindfulness-Based Cognitive Therapy (MBCT), developed by Zindel Segal, Mark Williams and John Teasdale, employs a cognitive theoretical framework (Cullen, 2011; Segal, Williams, & Teasdale, 2002). It is also delivered as an eight-session group treatment. The first four sessions teach the fundamental concepts and skills of the practice of mindfulness. The remaining four sessions teach the individual how to notice his/her own thoughts and the impact of such thoughts on his/her own physical and emotional experiences.

干预措施: Mindfulness-Based Cognitive Therapy (MBCT) (Behavioral)

结局指标

主要结局

Change of Perceived Stress Scale (PSS)

时间窗: [Time Frame: At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3).

Comparisons of changes of Perceived Stress Scale will be considered as follows: 1. T0 - T1 2. T0 - T2 3. T0 - T3 4. T1 - T2 5. T1 - T3 6. T2 - T3

次要结局

  • Change of Hospital Anxiety and Depression Scale (HADS)(At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3).)
  • Zarit Burden Inventory (ZBI)(At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3).)
  • Center for Epidemiologic Studies Depression Scale (CESD)(At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3).)

研究者

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

Wai-Tong Chien

Professor

The Hong Kong Polytechnic University

研究点 (2)

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