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| ID | Type | Description | Link |
|---|---|---|---|
| 23240241 | Other Grant/Funding Number | Health and Medical Research Fund |
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| Name | Class |
|---|---|
| Health and Medical Research Fund | OTHER_GOV |
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This study is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lonely adults with emigrant children (ME) | Experimental | Attend eight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice |
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| Lonely adults without emigrant children (MW) | Experimental | Attend eight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice |
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| Lonely adults with emigrant children (C) | Active Comparator | Receive eight health education and craft sessions, seven instant messages individually, four phone calls, and maintain usual activities without participating in mind-body exercise/ activities or stress reduction programme in 12-week |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Eight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Mindfulness-based Intervention (MBI) | 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%. | After the 12-week MBI training |
| Acceptability of the Mindfulness-based Intervention (MBI) | 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. | After the 12-week MBI training |
| Measure | Description | Time Frame |
|---|---|---|
| Loneliness | The Chinese version of the Revised University of California Los Angeles (R-UCLA) 3-item Loneliness Short Scale used to measure subjective feelings of loneliness. This 3-item, 4-point Likert scale (0 = "never", 3 = "always") yields scores from 0 to 9, with higher scores indicating greater perceived loneliness. Cronbach's for the Chinese R-UCLA is 0.87. | Baseline, week 12 and week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuen Ling LEUNG, Doctor of Nursing | Contact | (852)39708751 | lleung@hkmu.edu.hk | |
| Wing Yee HO, PhD | Contact | (852)27685835 | wyho@hkmu.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Yuen Ling Leung | Hong Kong Metropolitan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Metropolitan University | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Active Control | Other | Eight health education and craft sessions, seven instant messages individually, four phone calls, and maintain usual activities without participating in mind-body exercise/ activities or stress reduction programme in 12-week |
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| Sleep quality | The Chinese Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality over past month across seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunctions. This 19-item, 4-point Likert scale (0 = "no difficulty, 3 = "severe difficulty") generates scores from 0 to 21, with ≥8 indicates sleep disturbance. Cronbach's α for the Chinese PSQI is 0.79. | Baseline, week 12 and week 24 |
| Stress level | The Chinese 10-item Perceived Stress Scale (PSS-10) measures stress using a 5-point Likert scale (0 = "never", 4 = "very often") generate score from 0 to 40. It includes four positive items assessing stress adaptation and six negative items evaluating negative affective reactions and lack of control. Higher scores indicate greater stress. Cronbach's α for PSS-10 is 0.83. | Baseline, week 12 and week 24 |
| Participants' Quality of Life | The EuroQol 5-Dimension 5-Level (EQ-5D-5L) HK evaluates QoL across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels (no problem to extreme problems). A utility score (-1 to 1; <1 = "worse than death", 0 = "death", 1 = "full health") is derived for clinical and economic appraisal. | Baseline, week 12 and week 24 |
| Mindfulness | Chinese Five Facet Mindfulness Questionnaire (FFMQ-15) measures five mindfulness facets: Observe (Items 5, 8, 10, 12), Describing (Items 6, 13, 15), Act with awareness (Items 1, 2, 4, 7), Nonjudging (Items 9, 11, 14), and Nonreactive (Item 3). Each item is scored on a 5-point Likert scale (1 = "never or very rarely true", 5 = "very often or always true" for Observing, Describing, Nonreactivity; reversed for Acting with Awareness, Nonjudging). Higher summed scores indicate greater mindfulness. Cronbach's α for FFMQ-15 is 0.82 . | Baseline, week 12 and week 24 |
| Cardiometabolic outcomes |
| Baseline, week 12 and week 24 |
| Others | Behavioural outcomes, including change in dietary pattern, change in smoking and drinking habits including the type and amount, will be collected via a self-designed data sheet at each follow-up visit. | Baseline, week 12 and week 24 |
| D001523 |
| Mental Disorders |