Feasibility and Acceptability of Implementation of Mindfulness-Based Intervention for Community-Dwelling Older Adults With Emigrant Children Suffering From Loneliness: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Feasibility of Mindfulness-based Intervention (MBI)
研究概览
简要总结
This study is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study.
详细描述
The goal of this 3-arm randomized controlled trial is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study. It will identify the acceptability, feasibility, and potential effectiveness of the MBI for lonely older adults (OAs) with emigrant children. The main questions it aims to answer are:
- To what extent is the MBI study process feasible and acceptable for lonely OAs whose children have emigrated?
- Do subjects in the intervention group show significant improvements in loneliness levels, sleep quality, stress levels, and quality of life (QoL) during follow-up assessments at weeks 12 and 24 compared to baseline?
- How practical and effective is the recruitment process for enrolling the target study subjects?
Researchers will compare lonely adults with or without out emigrant children to see if MBI to reduce the loneliness level.
Participants will attend a 12-week programme with 8-section face-to-face MBI training, guided by 7 mindfulness video clips plus 4 individual support phone calls, and follow-up at week 12 and 24. In addition, an individual semi-structured interview will be carried out to explore the experience and perceived programme effects of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese adults aged 65 to 75 years,
- •able to communicate and understand Cantonese (class will be held in Cantonese),
- •OAs with or without emigrant children,
- •feeling of loneliness (3-item UCLA ≥6) [25], and
- •living in public housing, reliant on pension, savings, or living in subvented housing.
排除标准
- •Acute or severe physical symptoms such as impaired mobility, COPD or respiratory failure, uncontrolled epilepsy, and severe chronic pain syndrome,
- •Abbreviated Mental Test (AMT)< 6 [26],
- •met DSM-V TR criteria for treated or untreated major depressive disorder, bipolar disorder, cyclothymic disorder and/or on regular medication treatment,
- •have significant suicidal risk, and
- •previous experience in instructor-led mindfulness training within the half year prior to the commencement of the study.
结局指标
主要结局
Feasibility of Mindfulness-based Intervention (MBI)
时间窗: After the 12-week MBI training
The feasibility of the MBI will be evaluated using the following criteria: recruitment and retention rates. The recruitment rate is ≥80% of subject recruitment of the study, time required to recruit to target sample size (≤4 months for recruiting 45 subjects; ≤9 months for recruiting 90 subjects), Adverse Effects reported by the subjects is ≤5% for the whole study, attendance rate is ≥75% of subjects attend each session of health education, reasons for drop out or withdrawal from the study record in number and percentage, program completion rate of the subject ≥70%.
Acceptability of the Mindfulness-based Intervention (MBI)
时间窗: After the 12-week MBI training
Acceptability will be assessed via a self-developed evaluation form completed after the 12-week MBI training. The form has three-part: Part 1 includes 4 questions on perceived benefits of MBI; Part 2 includes 8 questions on satisfaction with MBI class arrangement; Part 3 includes 3 questions for suggestions and feedbacks. Questions 1 to 12 (part 1 and 2) use a five-point Likert Scale (5 = "Strongly agree", 1 = "strongly not agree"). Question 10 assesses subjects' willingness to continue MBI practice. Questions 13 and 15 (part 3) are open-ended, collecting "other comments" and suggestions for improving the MBI class, respectively.
次要结局
- Loneliness(Baseline, week 12 and week 24)
- Sleep quality(Baseline, week 12 and week 24)
- Stress level(Baseline, week 12 and week 24)
- Participants' Quality of Life(Baseline, week 12 and week 24)
- Mindfulness(Baseline, week 12 and week 24)
- Cardiometabolic outcomes(Baseline, week 12 and week 24)
- Others(Baseline, week 12 and week 24)
研究者
Dr Leona LEUNG Yuen Ling
Assistant Professor
Hong Kong Metropolitan University