LonelinessNCT07283549
Reducing Loneliness Among Older Adults in Hong Kong by Volunteer-delivered Mindfulness and Behavioral Activation Intervention
A study testing Tele-BA, Tele-MF and Tele-BF in people with Loneliness and Mental Health, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to recruit and train retirees and young people to be volunteers who will deliver the layperson-delivered, telephone-based behavioral activation and mindfulness intervention to older adults. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Mental Health
- What is being tested?
- Tele-BA, Tele-MF and Tele-BF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2024to 23 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 65 years older and above
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to recruit and train retirees and young people to be volunteers who will deliver the layperson-delivered, telephone-based behavioral activation and mindfulness intervention to older adults.
Read the detailed description
Retirees and young people will be recruited, trained, and delivered telephone-based psychosocial interventions to older adults.
- Conditions
- Loneliness, Mental Health
- Being tested
- Tele-BA, Tele-MF, Tele-BF
- Keywords
- Loneliness, Older Adults, Mental Health, Volunteers, Psychosocial Interventions
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-BABehavioural
Behavioral Activation
Tele-MFBehavioural
Mindfulness
Tele-BFOther
Befriending
| Study group | Role | What they receive |
|---|---|---|
| Tele-BA | Experimental | Behavioral Activation Receives: Behavioral: Tele-BA |
| Tele-MF | Experimental | Mindfulness Receives: Behavioral: Tele-MF |
| Tele-BF | Active comparator | Befriending Receives: Other: Tele-BF |
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, 4 weeks, 3 months
Secondary outcomes (5)
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, 4 weeks, 3 months
Anxiety
Hospital Anxiety and Depression Scale; Each item will be rated from 0=Not at all to 3=Most of the time. Total score range from 0 to 42.
Measured: Baseline, 4 weeks, 3 months
Sleep Quality
Sleep Condition Indicator; Each item will be rated from 0 to 4. Total score range from 0 to 32.
Measured: Baseline, 4 weeks, 3 months
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, 4 weeks, 3 months
Well-Being
Psychological Well-Being Scale; Each item will be rated from 1=strongly agree to 7=strongly disagree.
Measured: Baseline, 4 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Dec 2024
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chou Kee Lee, Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283549
- Sponsor's protocol ID
- 2023-2024-0570
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Loneliness Among Older Adults in Hong Kong by Volunteer-delivered Mindfulness and Behavioral Activation Intervention
- ClinicalTrials.gov ID
- NCT07283549
- Acronym / sponsor ID
- 2023-2024-0570
- Conditions
- Loneliness, Mental Health
- Keywords
- Loneliness, Older Adults, Mental Health, Volunteers, Psychosocial Interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 16 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.
This study aims to recruit and train retirees and young people to be volunteers who will deliver the layperson-delivered, telephone-based behavioral activation and mindfulness intervention to older adults.
Detailed description
Retirees and young people will be recruited, trained, and delivered telephone-based psychosocial interventions to older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tele-BA | Experimental | Behavioral: Tele-BABehavioral Activation |
| Tele-MF | Experimental | Behavioral: Tele-MFMindfulness |
| Tele-BF | Active comparator | Other: Tele-BFBefriending |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 65 years older and above
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Tele-BABehavioral Activation | Behavioural | Tele-BA |
| Tele-MFMindfulness | Behavioural | Tele-MF |
| Tele-BFBefriending | Other | Tele-BF |
Primary outcome
Loneliness
Time frame: Baseline, 4 weeks, 3 months
UCLA Loneliness Scale; Each item will be rated from 1=Never to 4=Always. Total scores range from 20 to 80.
5 secondary outcomes
Loneliness
Time frame: Baseline, 4 weeks, 3 months
Anxiety
Time frame: Baseline, 4 weeks, 3 months
Sleep Quality
Time frame: Baseline, 4 weeks, 3 months
Stress
Time frame: Baseline, 4 weeks, 3 months
Well-Being
Time frame: Baseline, 4 weeks, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Loneliness
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Hangeoreum: A Self-Paced Web-Based Program for Loneliness and Connectedness Among Korean Immigrants Aged 50 and Older
Loneliness, Korean
Not yet recruiting
Interpersonal Relational Role Analysis Group Therapy for Nursing Students at Risk of Internet Addiction
Internet Addiction
Active, not recruiting
PREWELL Digital Well-being Promotion Intervention With the BitHabit App
General Mental Health and Well-Being, Mental Disorders
Recruiting
Intergenerational Interaction Program for Nursing Home Residents and Nursing Students
Ageism, Loneliness
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-BA, Tele-MF and Tele-BF in people with Loneliness and Mental Health, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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, 4 weeks, 3 months). 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 19 Dec 2025.