Loneliness, Quality of Life, Sleep Quality, Stress
Conditions
Keywords
Mindfulness-based intervention, loneliness, older adults with emigrant children
Brief summary
This study is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study.
Detailed description
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: 1. To what extent is the MBI study process feasible and acceptable for lonely OAs whose children have emigrated? 2. 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? 3. 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.
Interventions
BEHAVIORALIntervention
Eight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice
OTHERActive Control
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
Sponsors
Hong Kong Metropolitan University
Health and Medical Research Fund
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Chinese adults aged 65 to 75 years, 2. able to communicate and understand Cantonese (class will be held in Cantonese), 3. OAs with or without emigrant children, 4. feeling of loneliness (3-item UCLA ≥6) \[25\], and 5. living in public housing, reliant on pension, savings, or living in subvented housing.
Exclusion criteria
1. Acute or severe physical symptoms such as impaired mobility, COPD or respiratory failure, uncontrolled epilepsy, and severe chronic pain syndrome, 2. Abbreviated Mental Test (AMT)\< 6 \[26\], 3. met DSM-V TR criteria for treated or untreated major depressive disorder, bipolar disorder, cyclothymic disorder and/or on regular medication treatment, 4. have significant suicidal risk, and 5. previous experience in instructor-led mindfulness training within the half year prior to the commencement of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Mindfulness-based Intervention (MBI) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Loneliness | Baseline, week 12 and week 24 | 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. |
| Sleep quality | Baseline, week 12 and week 24 | 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. |
| Stress level | Baseline, week 12 and week 24 | 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. |
| Participants' Quality of Life | Baseline, week 12 and week 24 | 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. |
| Mindfulness | Baseline, week 12 and week 24 | 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 . |
| Cardiometabolic outcomes | Baseline, week 12 and week 24 | * Blood pressure (BP) is measured using a validated upper-arm automated system after a 10-minute rest; averaging two readings taken 1-minute apart. * Anthropometric measures include waist circumference (nearest 0.1 cm), height (nearest 0.5cm no shoes), and body weight (nearest 0.1kg, light clothing, no shoes/socks, emptying bladder). * Body mass index is calculated as weight (kg) divided by height (m2). |
| Others | Baseline, week 12 and week 24 | 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. |
Countries
Hong Kong
Contacts
CONTACTYuen Ling LEUNG, Doctor of Nursing
CONTACTWing Yee HO, PhD
PRINCIPAL_INVESTIGATORYuen Ling Leung
Hong Kong Metropolitan University
Outcome results
None listed