LonelinessNCT07711860
Mindfulness for Lonely Older Adults With Emigrant Children
A study testing Intervention in people with Loneliness and Sleep Quality, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial summary
This study is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Sleep Quality, Quality of Life
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Hong Kong Metropolitan University
Hong Kong
Yuen Ling LEUNG, (852)39708751, lleung@hkmu.edu.hk
About this study
Official title: 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
This study is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study.
Read the 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:
- 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.
- Conditions
- Loneliness, Sleep Quality, Quality of Life, Stress
- Being tested
- Intervention, Active Control
- Keywords
- Mindfulness-based intervention, loneliness, older adults with emigrant children
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Eight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice
Active ControlOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Intervention |
| 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 Receives: Behavioral: Intervention |
| 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 Receives: Other: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: After the 12-week MBI training
Secondary outcomes (7)
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.
Measured: Baseline, week 12 and week 24
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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: Baseline, week 12 and week 24
Cardiometabolic outcomes
- 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).
Measured: 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.
Measured: Baseline, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Principal investigator, Dr Leona LEUNG Yuen Ling, Hong Kong Metropolitan University
- Investigators
- Yuen Ling Leung, Principal investigator, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711860
- Sponsor's protocol ID
- HE-HMRF2025/10
- Other IDs
- 23240241
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07711860
- Acronym / sponsor ID
- HE-HMRF2025/10
- Conditions
- Loneliness, Sleep Quality, Quality of Life, Stress
- Keywords
- Mindfulness-based intervention, loneliness, older adults with emigrant children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lonely adults with emigrant children (ME) | Experimental | Behavioral: InterventionAttend eight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice |
| Lonely adults without emigrant children (MW) | Experimental | Behavioral: InterventionAttend eight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice |
| Lonely adults with emigrant children (C) | Active comparator | Other: Active ControlReceive 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 |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionEight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice | Behavioural | Lonely adults with emigrant children (ME), Lonely adults without emigrant children (MW) |
| Active ControlEight 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 | Other | Lonely adults with emigrant children (C) |
Primary outcome
Feasibility of Mindfulness-based Intervention (MBI)
Time frame: 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)
Time frame: 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.
7 secondary outcomes
Loneliness
Time frame: Baseline, week 12 and week 24
Sleep quality
Time frame: Baseline, week 12 and week 24
Stress level
Time frame: Baseline, week 12 and week 24
Participants' Quality of Life
Time frame: Baseline, week 12 and week 24
Mindfulness
Time frame: Baseline, week 12 and week 24
Cardiometabolic outcomes
Time frame: Baseline, week 12 and week 24
Others
Time frame: Baseline, week 12 and week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuen Ling Leung principal investigator
Hong Kong Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Loneliness and Sleep Quality, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuen Ling LEUNG, Doctor of Nursing ((852)39708751, lleung@hkmu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Mindfulness-based Intervention (MBI) (time frame: After the 12-week MBI training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.