LonelinessNCT07308613
Developing and Testing a Machine Learning Enabled Mindfulness Intervention for Reducing Loneliness Among Hong Kong Chinese Older Adults
A study testing Mindfulness - Continue, Mindfulness - Enhance human coaching and Mindfulness - Booster in people with Loneliness, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
Develop and test an effective machine learning enabled application-based (app-based) mindfulness intervention for reducing loneliness of Hong Kong Chinese older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- Mindfulness - Continue, Mindfulness - Enhance human coaching and Mindfulness - Booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2026to 31 Dec 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 or older
- Possess a smartphone with an Android or iOS operating system
- Communicable in Cantonese
- Lonely (cut-off >/=6 on the three-item UCLA Loneliness Scale)
Who cannot join
- Cognitive impairment, psychiatric disorder, learning disability
- Active suicide ideation
- Engaged in psychotherapy and psychosocial interventions in the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Testing a Machine Learning Enabled Mindfulness Intervention for Reducing Loneliness Among Hong Kong Chinese Older Adults: A Hybrid Experimental Design Study
Develop and test an effective machine learning enabled application-based (app-based) mindfulness intervention for reducing loneliness of Hong Kong Chinese older adults.
Read the detailed description
This study will utilize a hybrid Sequential Multiple Assignment Randomized Trial-Micro Randomized Trial (Hybrid SMART-MRT) to: 1) evaluate the effectiveness of a single-session intervention (SSI) of mindfulness on reducing loneliness; 2) identify the optimal first-line coaching approach after the SSI of mindfulness; 3) examine whether increasing the intensity of human coaching or adding a telephone-based human-delivered booster session will benefit participants who do not respond to the first-line coaching; 4) determine whether sending push notifications increases the engagement of our app-based coaching, by comparing its results with those of no push notification; 5) determine whether sending a recommended activity increases the engagement of our app-based coaching, by comparing its results with those of no recommended activity; and 6) determine whether sending a personalized motivational message increases the engagement of our app-based coaching, by comparing its results with those of a standard motivational message.
- Conditions
- Loneliness
- Being tested
- Mindfulness - Continue, Mindfulness - Enhance human coaching, Mindfulness - Booster, Active Control
- Keywords
- Loneliness, Older Adults, Mindfulness, hybrid SMART-MRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness - ContinueBehavioural
Second-line of coaching (4 weeks):
Continue with existing intervention plan
Mindfulness - Enhance human coachingBehavioural
Second-line of coaching (4 weeks):
Increase intensity of human coaching
Mindfulness - BoosterBehavioural
Second-line of coaching (4 weeks):
Add a booster session
Active ControlBehavioural
No rerandomization, no mindfulness, No MRT
| Study group | Role | What they receive |
|---|---|---|
| App & Human Coaching + Continue Intervention | Experimental | First-line of coaching (4 weeks):
Single-Session Intervention of Mindfulness (App + Human Coaching) Responder Receives: Behavioral: Mindfulness - Continue |
| Active Control | Active comparator | Active Control Receives: Behavioral: Active Control |
| App & Human Coaching + Increase intensity in human coaching | Experimental | First-line of coaching (4 weeks):
Single-Session Intervention of Mindfulness (App + Human Coaching) Non-Responder Receives: Behavioral: Mindfulness - Enhance human coaching |
| App & Human Coaching + Booster | Experimental | First-line of coaching (4 weeks):
Single-Session Intervention of Mindfulness (App + Human Coaching) Non-Responder Receives: Behavioral: Mindfulness - Booster |
| App Coaching + Continue Intervention | Experimental | First-line of coaching (4 weeks):
Single-Session Intervention of Mindfulness (App Coaching) Responder Receives: Behavioral: Mindfulness - Continue |
| App Coaching + Increase intensity in human coaching | Experimental | First-line of coaching (4 weeks):
Single-Session Intervention of Mindfulness (App Coaching) Non-Responder Receives: Behavioral: Mindfulness - Enhance human coaching |
| App Coaching + Booster | Experimental | First-line of coaching (4 weeks):
Single-Session Intervention of Mindfulness (App Coaching) Non-Responder Receives: Behavioral: Mindfulness - Booster |
| Human Coaching + Continue Intervention | Experimental | First-line of coaching (4 weeks):
Single-Session Intervention of Mindfulness (Human Coaching) Responder Receives: Behavioral: Mindfulness - Continue |
| Human Coaching + Increase intensity in human coaching | Experimental | First-line of coaching (4 weeks):
Single-Session Intervention of Mindfulness (Human Coaching) Non-Responder Receives: Behavioral: Mindfulness - Enhance human coaching |
| Human Coaching + Booster | Experimental | First-line of coaching (4 weeks):
Single-Session Intervention of Mindfulness (Human Coaching) Non-Responder Receives: Behavioral: Mindfulness - Booster |
| No Coaching + Continue Intervention | Experimental | First-line of coaching (4 weeks):
No Single-Session Intervention of Mindfulness Responder Receives: Behavioral: Mindfulness - Continue |
| No Coaching + Increase intensity in human coaching | Experimental | First-line of coaching (4 weeks):
No Single-Session Intervention of Mindfulness Non-Responder Receives: Behavioral: Mindfulness - Enhance human coaching |
| No Coaching + Booster | Experimental | First-line of coaching (4 weeks):
No Single-Session Intervention of Mindfulness Non-Responder Receives: Behavioral: Mindfulness - Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
UCLA Loneliness Scale; each item will be rated from 1=Never to 4=Always. Total scores range from 20 to 80
Measured: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Secondary outcomes (11)
Loneliness
De Jong Gierveld Loneliness Scale; each item will be rated from 1=Yes to 3=No. Total scores range from 0 to 6, with subscale score ranging from 0 to 3.
Measured: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Stress
Perceived Stress Scale; each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 56.
Measured: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Sleep Quality
Pittsburgh Sleep Quality Index; each item will be rated from 0=No difficulty to 3=Severe difficulty. Total scores range from 0 to 21.
Measured: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Depression
Patient Health Questionnaire-9; Each item will be rated from 0=Not at all to 3=nearly everyday. Total scores range from 0 to 27
Measured: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Anxiety
Generalised Anxiety Disorder; each item will be rated from 0=not at all to 3=nearly every day. Total score range from 0 to 21.
Measured: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Physical Health
Lawton Instrumental Activities of Daily Living; each item will be rated 0=dependent to 1=independent. Total scores range from 0 to 8.
Measured: Baseline (T0), 6 months after 2nd-line of coaching (T4)
Physical Health
Activities of Daily Living; each item will be rate from 0=dependent to 5/10=independent. Total scores range from 0 to 100.
Measured: Baseline (T0), 6 months after 2nd-line of coaching (T4)
Physical Symptoms
Wahler Physical Symptoms Inventory; each item will be rated from 0=almost never agree to 5=agree almost every day. Total score range from 0 to 210.
Measured: Baseline (T0), 6 months after 2nd-line of coaching (T4)
Chronic Illness
Participants will indicate any presence of chronic illness (e.g., diabetes, asthma, high blood pressure).
Measured: Baseline (T0), 6 months after 2nd-line of coaching (T4)
Multidimensional Scale of Perceived Social Support
MSPSS evaluates the social support derived from three key sources: family, friends, and significant others. Each item will be rated from 1=Strongly disagree to 7=Strongly agree. Total scores range from 12 to 84.
Measured: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Lubben Social Network Scale
LSNS is used to assess the social networks of participants. Each item will be rated 0=None to 5=9 or more. Total scores range from 0 to 30.
Measured: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A hybrid factorial-SMART-MRT experimental design with a 2x2+1 factorial design (with five arms) randomized clinical trial, a two-stage SMART, and three MRTs will be utilized.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin
- Responsible party
- Principal investigator, Chou Kee Lee, Education University of Hong Kong
- Investigators
- Kee Lee Chou, PhD, Principal investigator, The Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308613
- Sponsor's protocol ID
- 2023-2024-0147
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Machine Learning Enabled Mindfulness Intervention for Reducing Loneliness Among Hong Kong Chinese Older Adults: A Hybrid Experimental Design Study
- ClinicalTrials.gov ID
- NCT07308613
- Acronym / sponsor ID
- 2023-2024-0147
- Conditions
- Loneliness
- Keywords
- Loneliness, Older Adults, Mindfulness, hybrid SMART-MRT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Collaborators
- University of Texas at Austin
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Dec 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.
Develop and test an effective machine learning enabled application-based (app-based) mindfulness intervention for reducing loneliness of Hong Kong Chinese older adults.
Detailed description
This study will utilize a hybrid Sequential Multiple Assignment Randomized Trial-Micro Randomized Trial (Hybrid SMART-MRT) to: 1) evaluate the effectiveness of a single-session intervention (SSI) of mindfulness on reducing loneliness; 2) identify the optimal first-line coaching approach after the SSI of mindfulness; 3) examine whether increasing the intensity of human coaching or adding a telephone-based human-delivered booster session will benefit participants who do not respond to the first-line coaching; 4) determine whether sending push notifications increases the engagement of our app-based coaching, by comparing its results with those of no push notification; 5) determine whether sending a recommended activity increases the engagement of our app-based coaching, by comparing its results with those of no recommended activity; and 6) determine whether sending a personalized motivational message increases the engagement of our app-based coaching, by comparing its results with those of a standard motivational message.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 13
- Model description
- A hybrid factorial-SMART-MRT experimental design with a 2x2+1 factorial design (with five arms) randomized clinical trial, a two-stage SMART, and three MRTs will be utilized.
| Arm | Type | Receives |
|---|---|---|
| App & Human Coaching + Continue Intervention | Experimental | Behavioral: Mindfulness - ContinueFirst-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App + Human Coaching) Responder |
| Active Control | Active comparator | Behavioral: Active ControlActive Control |
| App & Human Coaching + Increase intensity in human coaching | Experimental | Behavioral: Mindfulness - Enhance human coachingFirst-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App + Human Coaching) Non-Responder |
| App & Human Coaching + Booster | Experimental | Behavioral: Mindfulness - BoosterFirst-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App + Human Coaching) Non-Responder |
| App Coaching + Continue Intervention | Experimental | Behavioral: Mindfulness - ContinueFirst-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App Coaching) Responder |
| App Coaching + Increase intensity in human coaching | Experimental | Behavioral: Mindfulness - Enhance human coachingFirst-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App Coaching) Non-Responder |
| App Coaching + Booster | Experimental | Behavioral: Mindfulness - BoosterFirst-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App Coaching) Non-Responder |
| Human Coaching + Continue Intervention | Experimental | Behavioral: Mindfulness - ContinueFirst-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (Human Coaching) Responder |
| Human Coaching + Increase intensity in human coaching | Experimental | Behavioral: Mindfulness - Enhance human coachingFirst-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (Human Coaching) Non-Responder |
| Human Coaching + Booster | Experimental | Behavioral: Mindfulness - BoosterFirst-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (Human Coaching) Non-Responder |
| No Coaching + Continue Intervention | Experimental | Behavioral: Mindfulness - ContinueFirst-line of coaching (4 weeks): No Single-Session Intervention of Mindfulness Responder |
| No Coaching + Increase intensity in human coaching | Experimental | Behavioral: Mindfulness - Enhance human coachingFirst-line of coaching (4 weeks): No Single-Session Intervention of Mindfulness Non-Responder |
| No Coaching + Booster | Experimental | Behavioral: Mindfulness - BoosterFirst-line of coaching (4 weeks): No Single-Session Intervention of Mindfulness Non-Responder |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65 or older
- Possess a smartphone with an Android or iOS operating system
- Communicable in Cantonese
- Lonely (cut-off >/=6 on the three-item UCLA Loneliness Scale)
Key exclusion criteria (3 listed)
- Cognitive impairment, psychiatric disorder, learning disability
- Active suicide ideation
- Engaged in psychotherapy and psychosocial interventions in the past year
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 |
|---|---|---|
| Mindfulness - ContinueSecond-line of coaching (4 weeks): Continue with existing intervention plan | Behavioural | App & Human Coaching + Continue Intervention, App Coaching + Continue Intervention, Human Coaching + Continue Intervention, No Coaching + Continue Intervention |
| Mindfulness - Enhance human coachingSecond-line of coaching (4 weeks): Increase intensity of human coaching | Behavioural | App & Human Coaching + Increase intensity in human coaching, App Coaching + Increase intensity in human coaching, Human Coaching + Increase intensity in human coaching, No Coaching + Increase intensity in human coaching |
| Mindfulness - BoosterSecond-line of coaching (4 weeks): Add a booster session | Behavioural | App & Human Coaching + Booster, App Coaching + Booster, Human Coaching + Booster, No Coaching + Booster |
| Active ControlNo rerandomization, no mindfulness, No MRT | Behavioural | Active Control |
Primary outcome
Loneliness
Time frame: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
UCLA Loneliness Scale; each item will be rated from 1=Never to 4=Always. Total scores range from 20 to 80
11 secondary outcomes
Loneliness
Time frame: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Stress
Time frame: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Sleep Quality
Time frame: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Depression
Time frame: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Anxiety
Time frame: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Physical Health
Time frame: Baseline (T0), 6 months after 2nd-line of coaching (T4)
Physical Health
Time frame: Baseline (T0), 6 months after 2nd-line of coaching (T4)
Physical Symptoms
Time frame: Baseline (T0), 6 months after 2nd-line of coaching (T4)
Chronic Illness
Time frame: Baseline (T0), 6 months after 2nd-line of coaching (T4)
Multidimensional Scale of Perceived Social Support
Time frame: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Lubben Social Network Scale
Time frame: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
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 Sep 2026.
- Individual participant dataSharing planned: Yes. Data sharing will be available upon reasonable request.
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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. This study is not recruiting at the moment.
Kee Lee Chou, PhD principal investigator
The Education University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness - Continue, Mindfulness - Enhance human coaching and Mindfulness - Booster in people with Loneliness, run by Education University of Hong Kong 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)). 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 Sep 2026.