Long Term Care FacilityNCT06932731
Mind-Body Intervention for Older Adults in Long-term Care
A study testing Mind-body Intervention and Befriending Intervention in people with Long Term Care Facility, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
Loneliness is a global health issue, particularly affecting the physical and mental health of older adults residing in long term care. The COVID-19 pandemic has further exacerbated isolation in these settings, calling for an urgent attention for finding an effective intervention to alleviate loneliness among long term… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long Term Care Facility
- What is being tested?
- Mind-body Intervention and Befriending Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesHong Kong
- Study dates
- 17 Apr 2025to Jun 2027
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Long-term care residents aged 60 or above
- Communicable in Cantonese/Chinese
- Mentally competent (Abbreviated Mental Test score >6)
- Could read, write and understand Chinese language
- Able to provide written consent
Who cannot join
- Have regular practice of mindfulness once a week or more during the past 6 months
- Have any other contraindication or severe comorbidity that may limit their full participation (e.g. acute psychiatric conditions, severe hearing, vision impairment, or severe medical condition etc).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Not yet recruiting
School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
Hong Kong
Cheuk Yan Szeto, MScN, +85236536780, jodies@connect.hku.hk
Cheuk Yan Szeto, MSc
- Recruiting
School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
Hong Kong
Cheuk Yan Szeto, MScN, +85236536780, jodies@connect.hku.hk
Cheuk Yan Szeto, MScN
About this study
Official title: The Effects of Mind-Body Intervention Versus Befriending Intervention on Loneliness for Older Adults in Long-term Care: A Randomised Controlled Trial
Loneliness is a global health issue, particularly affecting the physical and mental health of older adults residing in long term care. The COVID-19 pandemic has further exacerbated isolation in these settings, calling for an urgent attention for finding an effective intervention to alleviate loneliness among long term care residents. Mind-body interventions (MBIs) present as a potentially promising approach aimed at reducing loneliness and mental wellbeing. This study aims to examine the effect of a nurse-led MBI compared to a befriending intervention on loneliness, quality of life, depression and level of mindfulness among older adults in long term care. The primary outcome is loneliness while secondary outcome is quality of life, depression and level of mindfulness.
Read the detailed description
Loneliness is becoming a global health threat particularly in older population due to natural life events such as illness, death of a spouse and a lack of friends In Hong Kong, it has been reported the 58.1% of the older people experienced a high level of loneliness. Loneliness can have a devastating impact on mental and physical health by increasing the risk of dementia, depression, anxiety, stroke, myocardial infarction and poor quality of sleep.The associated mortality rate can be as high as 26% which is comparable to the harm of prime health dangers like alcohol and cigarette. The problem is particularly pressing for the older adults residing in long term care facilities during the COVID-19 pandemic. Outbreaks occurred in more than 90% of long-term care facility in Hong Kong. Resulting in further isolation in their own facilities or community isolation facilities. Preventing institutionalized older adults from being trapped in loneliness is of key importance. A promotion of intervention that is driven by theoretical framework and suitable for long-term care setting is required.
Mind-body practice has been extensively studied in different population such as chronic pain, heart disease, respiratory disease and community dwelling older adults. However, there is little evidence of wellbeing and loneliness reduction in mind-body practice among long term care older adults. This study will adopt befriending intervention as the control group. As befriending intervention is common in Hong Kong by volunteer visiting.
This study describes a randomised controlled trial designed to compare the effectiveness of a nurse-led MBI versus befriending intervention for LTC residents to reduce loneliness and enhance wellbeing.
- Conditions
- Long Term Care Facility
- Being tested
- Mind-body Intervention, Befriending Intervention
- Keywords
- loneliness, mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body InterventionBehavioural
The Mind-Body Intervention group designed to included several elements with mind and body involvement such as mindful breathing, body scan, stretching, mindful movement as well as adapting mindful practice in their routine. Mind-Body Intervention group will join the activities in a group setting for 5 sessions. Each session 45 to 60 minutes. Intervention is led by a registered nurse. Each session (except for the first session) will start by sharing of practice from the past week. Followed by mind-body practices. Before the end of session, a group discussion on the practice of that day and reflection will be done.
Befriending InterventionBehavioural
In this group, volunteer will spend time with the participants, engaging in conversation and join their routine activities by the time of visit or other scheduled activities in the institution (such as arts and crafts, playing board games or reminiscing activities).
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body Intervention Group | Experimental | The entire intervention will be conducted in a group setting for 5 sessions. Each session 45 to 60 minutes weekly. Intervention is led by a registered nurse. Participants will be instructed to perform mind-body intervention during session and encouraged to have home practice between the next session. Receives: Behavioral: Mind-body Intervention |
| Befriending Intervention Group | Active comparator | This group will receive befriending intervention provided by volunteers with health care background. Volunteers are either studying or graduated from a health science related programme. Participants will meet volunteers each week in a group setting for 5 sessions. Each session 45 to 60 minutes. Receives: Behavioral: Befriending Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
For Mind-Body Intervention group and Befriending Intervention group, measured by UCLA 8-item Loneliness Scale is the shortened version of UCLA Loneliness Scale. The shortened scale consists of 8 questions with 4-point Likert scale ranged from 'never' to 'often'. The higher the score, the higher the level of perceived loneliness. Item 3 and Item 5 are reversely scored. Higher the score, the higher loneliness level.
Measured: Baselines , 5 weeks, and 12 weeks after baseline
Secondary outcomes (3)
Level of mindfulness
For Mind-Body Intervention group and Befriending Intervention group, measured by Multidimentional Assessment of Interoceptive Awareness (MAIA). It is a 32 items state-trait self reported questionnaires and is categorized into eight scales in 6 point Likert scale from 0 (never ) to 5 (always). A higher score indicates a more appraised interoceptive awareness and higher level of mindfulness.
Measured: Baselines , 5 weeks, and 12 weeks after baseline
Depression
For Mind-Body Intervention group and Befriending Intervention group, measured by Geriatric Depression Scale 4 items (GDS-4) is a brief version of Geriatric Depression Scale 30 items (GDS-30). GDS-4 consists of 4 items from the original items of GDS-30. Total scores more than 2 is considered at risk of depression.
Measured: Baseline, 5 weeks, and 12 weeks after baseline
Health-related quality of life
For Mind-Body Intervention group and Befriending Intervention group, measured by World Health Organization Well-Being Index (WHO-5 scale). It is a five items 6-point Likert-type scale from 0 (at no time) to 5 (all of the time). It focuses on positive emotions that included 5 items: "I have felt cheerful and in good spirits", "I have felt calm and relaxed", "I have felt cheerful and in good spirits", "I woke up feeling fresh and rested" and "I have felt active and vigorous". The participants are asked how well each of the items applied to them in the past two weeks. The higher the score, the better the mental wellbeing.
Measured: Baseline , 5 weeks, and 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start17 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Care FacilityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Szeto Cheuk Yan, The University of Hong Kong
- Investigators
- Jojo Yan Yan Kwok, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932731
- Sponsor's protocol ID
- UW 25-016
- Status last verified
- Aug 2025
- First submitted
- 10 Apr 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data supporting the findings of this study are available upon request from the principal investigator, Ms Szeto. These data are not publicly available, as they contain information that could compromise the privacy of research participants.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mind-Body Intervention Versus Befriending Intervention on Loneliness for Older Adults in Long-term Care: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06932731
- Acronym / sponsor ID
- UW 25-016
- Conditions
- Long Term Care Facility
- Keywords
- loneliness, mindfulness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Apr 2025 (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.
Loneliness is a global health issue, particularly affecting the physical and mental health of older adults residing in long term care. The COVID-19 pandemic has further exacerbated isolation in these settings, calling for an urgent attention for finding an effective intervention to alleviate loneliness among long term care residents. Mind-body interventions (MBIs) present as a potentially promising approach aimed at reducing loneliness and mental wellbeing. This study aims to examine the effect of a nurse-led MBI compared to a befriending intervention on loneliness, quality of life, depression and level of mindfulness among older adults in long term care. The primary outcome is loneliness while secondary outcome is quality of life, depression and level of mindfulness.
Detailed description
Loneliness is becoming a global health threat particularly in older population due to natural life events such as illness, death of a spouse and a lack of friends In Hong Kong, it has been reported the 58.1% of the older people experienced a high level of loneliness. Loneliness can have a devastating impact on mental and physical health by increasing the risk of dementia, depression, anxiety, stroke, myocardial infarction and poor quality of sleep.The associated mortality rate can be as high as 26% which is comparable to the harm of prime health dangers like alcohol and cigarette. The problem is particularly pressing for the older adults residing in long term care facilities during the COVID-19 pandemic. Outbreaks occurred in more than 90% of long-term care facility in Hong Kong. Resulting in further isolation in their own facilities or community isolation facilities. Preventing institutionalized older adults from being trapped in loneliness is of key importance. A promotion of intervention that is driven by theoretical framework and suitable for long-term care setting is required.
Mind-body practice has been extensively studied in different population such as chronic pain, heart disease, respiratory disease and community dwelling older adults. However, there is little evidence of wellbeing and loneliness reduction in mind-body practice among long term care older adults. This study will adopt befriending intervention as the control group. As befriending intervention is common in Hong Kong by volunteer visiting.
This study describes a randomised controlled trial designed to compare the effectiveness of a nurse-led MBI versus befriending intervention for LTC residents to reduce loneliness and enhance wellbeing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Intervention Group | Experimental | Behavioral: Mind-body InterventionThe entire intervention will be conducted in a group setting for 5 sessions. Each session 45 to 60 minutes weekly. Intervention is led by a registered nurse. Participants will be instructed to perform mind-body intervention during session and encouraged to have home practice between the next session. |
| Befriending Intervention Group | Active comparator | Behavioral: Befriending InterventionThis group will receive befriending intervention provided by volunteers with health care background. Volunteers are either studying or graduated from a health science related programme. Participants will meet volunteers each week in a group setting for 5 sessions. Each session 45 to 60 minutes. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Long-term care residents aged 60 or above
- Communicable in Cantonese/Chinese
- Mentally competent (Abbreviated Mental Test score >6)
- Could read, write and understand Chinese language
- Able to provide written consent
Key exclusion criteria (2 listed)
- Have regular practice of mindfulness once a week or more during the past 6 months
- Have any other contraindication or severe comorbidity that may limit their full participation (e.g. acute psychiatric conditions, severe hearing, vision impairment, or severe medical condition etc).
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 |
|---|---|---|
| Mind-body InterventionThe Mind-Body Intervention group designed to included several elements with mind and body involvement such as mindful breathing, body scan, stretching, mindful movement as well as adapting mindful practice in their routine. Mind-Body Intervention group will join the activities in a group setting for 5 sessions. Each session 45 to 60 minutes. Intervention is led by a registered nurse. Each session (except for the first session) will start by sharing of practice from the past week. Followed by mind-body practices. Before the end of session, a group discussion on the practice of that day and reflection will be done. | Behavioural | Mind-Body Intervention Group |
| Befriending InterventionIn this group, volunteer will spend time with the participants, engaging in conversation and join their routine activities by the time of visit or other scheduled activities in the institution (such as arts and crafts, playing board games or reminiscing activities). | Behavioural | Befriending Intervention Group |
Primary outcome
Loneliness
Time frame: Baselines , 5 weeks, and 12 weeks after baseline
For Mind-Body Intervention group and Befriending Intervention group, measured by UCLA 8-item Loneliness Scale is the shortened version of UCLA Loneliness Scale. The shortened scale consists of 8 questions with 4-point Likert scale ranged from 'never' to 'often'. The higher the score, the higher the level of perceived loneliness. Item 3 and Item 5 are reversely scored. Higher the score, the higher loneliness level.
3 secondary outcomes
Level of mindfulness
Time frame: Baselines , 5 weeks, and 12 weeks after baseline
Depression
Time frame: Baseline, 5 weeks, and 12 weeks after baseline
Health-related quality of life
Time frame: Baseline , 5 weeks, and 12 weeks after baseline
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 14 Apr 2026.
- Individual participant dataSharing planned: No. The data supporting the findings of this study are available upon request from the principal investigator, Ms Szeto. These data are not publicly available, as they contain information that could compromise the privacy of research participants.
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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.
Jojo Yan Yan Kwok, PhD principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-body Intervention and Befriending Intervention in people with Long Term Care Facility, run by The University of Hong Kong at 2 sites 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 2 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Cheuk Yan Szeto, MScN (+85236536780, jodies@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: Baselines , 5 weeks, and 12 weeks after baseline). 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 14 Apr 2026.