LonelinessNCT07123064
Alleviating Loneliness in Older Adults Living in Poverty: A Multi-level Intervention
A study testing Individual Level, Interpersonal Level and Community Level in people with Loneliness and Poverty, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
The study aims to reduce loneliness among Hong Kong Chinese older adults living in poverty with a multi-level intervention involving components at the individual, interpersonal, and community levels. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Poverty
- What is being tested?
- Individual Level, Interpersonal Level and Community Level
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,344 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2026to 31 May 2029
- 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 years or older
- living in poverty (defined: inability to afford at least 5 items on the material deprivation index)
- proficiency in spoken Cantonese
- experiencing loneliness (defined: score of ≥ 6 on the 3-item UCLA Loneliness Scale)
Who cannot join
- cognitive impairments, psychiatric disorders, learning disabilities, or active suicidal ideation
- actively participating in other psychotherapy or psychosocial interventions in the past 1 year
- -
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, 1 recruiting
- Recruiting
The Education University of Hong Kong
Hong Kong
Kee Lee Chou, PhD, +85229487473, klchou@eduhk.hk
Vivien Tang, MSc, s1135125@s.eduhk.hk
About this study
The study aims to reduce loneliness among Hong Kong Chinese older adults living in poverty with a multi-level intervention involving components at the individual, interpersonal, and community levels.
Read the detailed description
Loneliness is widespread, with negative impacts on both individuals and society and associated direct and indirect healthcare and long-term care costs. Thus, it is imperative to alleviate loneliness in old age by implementing effective, accessible, affordable, and scalable interventions. Loneliness is often erroneously considered an individual problem due to personal failure. Still, growing evidence indicates that loneliness is caused by factors at multiple levels, including the individual, interpersonal, and community levels. Hence, a multi-level approach is recommended to alleviate loneliness.
However, multi-level interventions for reducing loneliness are in their infancy, and there is yet to be evidence to suggest that they are more effective than single-level interventions. The investigators will conduct an innovative and impactful study to fill this important research gap. This study is a single-blinded cluster, four-arm randomized controlled trial (RCT) designed to test the effect and cost-effectiveness of a multi-level intervention to alleviate loneliness among Hong Kong Chinese older adults living in poverty. The investigators will also adopt the modified biopsychosocial (BPS) model, called the BPS-Pathways model, as the theoretical framework to guide our selection of interventions, mediators, secondary outcomes, long-term outcomes, and impact.
- Conditions
- Loneliness, Poverty
- Being tested
- Individual Level, Interpersonal Level, Community Level, Education Control
- Keywords
- Loneliness, Poverty, Cluster Randomized Controlled Trials, Older Adults, Mindfulness, SOLUS-D Programme, Group 4 Health, Neighbour Every Day, Hong Kong
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual LevelBehavioural
A 8-weekly, 1hour telephone-delivered sessions using mindfulness and SOLUS-D program. Key contents include: introduction to mindfulness - Body awareness and present moment experiences, emotional awareness and mind-body labeling, relaxation techniques and sensory discrimination, deepening awareness and accepting feelings, personal values, interconnection between thought patterns and emotions, identifying and analyzing of thought traps, and challenging thoughts and future planning. Maintenance sessions which focus on embedding mindfulness practices and SOLUS-D program among older adults as a persistent habit will be conducted.
Interpersonal LevelBehavioural
A 8 weekly, 1hr sessions through telephone or Zoom using the Group 4 Health. Key contents include: understanding the benefits of social connections, exploring self and community, community and action, support and breakthrough, summary and moving forward. Maintenance sessions which focus on continuous practice of support and community will be conducted.
Community LevelBehavioural
A 4 weekly, 2hour in-person sessions through (1) strengthening collective efficacy via neighbor identification with the community. Key contents include: building neighbourhood connections, getting to know each other, health aging, neighbourhood care, vibrant exploration, thriving community, connecting the dots.
Education ControlOther
Monthly monthly messages via text, graphics or voice recordings will be sent over a period of 6 months. Key content includes: healthy diet tips, recognizing warning signs of health, understanding dementia, fall prevention tips, health message, and anti-fraud tips.
| Study group | Role | What they receive |
|---|---|---|
| First Arm | Experimental | Individual-level Receives: Behavioral: Individual Level |
| Second Arm | Experimental | Individual- and Interpersonal-level Receives: Behavioral: Individual Level; Behavioral: Interpersonal Level |
| Third Arm | Experimental | Individual-, Interpersonal-, and Community-level Receives: Behavioral: Individual Level; Behavioral: Interpersonal Level; Behavioral: Community Level |
| Forth Arm | Active comparator | Education Control Group Receives: Other: Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Loneliness Scale
The 20-item UCLA Loneliness Scale is a reliable self-assessment tool designed to evaluate feelings of loneliness. Each item will be rated from 1=Never to 4=Always. Total scores range from 20 to 80.
Measured: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month
Secondary outcomes (11)
Pittsburgh Sleep Quality Index
PSQI evaluates seven components of sleep: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. Each item will be rated from 0=No difficulty to 3=Severe difficulty. Total scores range from 0 to 21,
Measured: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month
Satisfaction with Life Scale
SWLS measures the subjective well-being and life satisfaction. Each item will be rated from 1=Strongly disagree to 7=Strongly agree. Total scores range from 5 to 35.
Measured: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month
De Jong Gierveld Loneliness Scale
The De Jong Gierveld Loneliness Scale is known for assessing loneliness with social and emotional loneliness subscale. 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, 2-month, 4-month, 6-month, 12-month, 24-month
Lawton Instrumental Activities of Daily Living
IADL is used to measure participant's ability in performing instrumental activities. Each item will be rated 0=dependent to 1=independent. Total scores range from 0 to 8.
Measured: Baseline, 12-month, 24-month
Activities of Daily Living
ADL is used to measure participant's independence in completing 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, 12-month, 24-month
Physical Symptoms Inventory
Participants will rate the presence of each physical symptom in the past 30 days from 0=Never to 4=Often. Total scores range from 0 to 72.
Measured: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month
Charlson Comorbidity Index
Participants will rate the presence a list of 16 comorbid condition. Total scores range from 0 to 37.
Measured: Baseline, 12-month, 24-month
Perceived Stress Scale
PSS is use to measure perceived stress levels. Each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 56.
Measured: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month
6-Minutes Walking Test
Participants will be asked to walk the furthest distance possible in 6 minutes, rate their level of breathlessness using the Borg scale from 0=No breathlessness to 10=Maximal breathlessness.
Measured: Baseline, 12-month, 24-month
Hospital Anxiety and Depression Scale
HADS measure the severity of anxiety and depression. 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, 2-month, 4-month, 6-month, 12-month, 24-month
Montreal Cognitive Assessment - Hong Kong
MoCA-HK is a tool to evaluate cognitive functioning in older adults, which compromises of seven cognitive domains. Total score range from 0 to 30.
Measured: Baseline, 12-month, 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Apr 2026
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- 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
- Model description
- Single Blinded, 4-arm cluster randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, The Hong Kong Polytechnic University, University of Texas at Austin, Australian National University, The University of Hong Kong, Medical School Berlin, Chinese University of Hong Kong, University of Bern, Linkoeping University
- 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
- NCT07123064
- Sponsor's protocol ID
- 2023-2024-0624
- Other IDs
- R8002-24
- Status last verified
- Feb 2026
- First submitted
- 8 Aug 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Surkalim DL, Luo M, Eres R, Gebel K, van Buskirk J, Bauman A, Ding D. The prevalence of loneliness across 113 countries: systematic review and meta-analysis. BMJ. 2022 Feb 9;376:e067068. doi: 10.1136/bmj-2021-067068.
PubMed 35140066Seguin-Fowler RA, Graham ML, Demment M, Uribe ALM, Rethorst CD, Szeszulski J. Multilevel Interventions Targeting Obesity: State of the Science and Future Directions. Annu Rev Nutr. 2024 Aug;44(1):357-381. doi: 10.1146/annurev-nutr-122123-020340. Epub 2024 Aug 12.
PubMed 38885446Santini ZI, Koyanagi A, Tyrovolas S, Haro JM, Fiori KL, Uwakwa R, Thiyagarajan JA, Webber M, Prince M, Prina AM. Social network typologies and mortality risk among older people in China, India, and Latin America: A 10/66 Dementia Research Group population-based cohort study. Soc Sci Med. 2015 Dec;147:134-43. doi: 10.1016/j.socscimed.2015.10.061. Epub 2015 Nov 4.
PubMed 26575604Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
PubMed 20957426Masi CM, Chen HY, Hawkley LC, Cacioppo JT. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66. doi: 10.1177/1088868310377394. Epub 2010 Aug 17.
PubMed 20716644Lloyd-Evans B, Frerichs J, Stefanidou T, Bone J, Pinfold V, Lewis G, Billings J, Barber N, Chhapia A, Chipp B, Henderson R, Shah P, Shorten A, Giorgalli M, Terhune J, Jones R, Johnson S. The Community Navigator Study: Results from a feasibility randomised controlled trial of a programme to reduce loneliness for people with complex anxiety or depression. PLoS One. 2020 May 29;15(5):e0233535. doi: 10.1371/journal.pone.0233535. eCollection 2020.
PubMed 32469922Lengnick-Hall R, Williams NJ, Ehrhart MG, Willging CE, Bunger AC, Beidas RS, Aarons GA. Eight characteristics of rigorous multilevel implementation research: a step-by-step guide. Implement Sci. 2023 Oct 23;18(1):52. doi: 10.1186/s13012-023-01302-2.
PubMed 37872618Hunter RF, de la Haye K, Murray JM, Badham J, Valente TW, Clarke M, Kee F. Social network interventions for health behaviours and outcomes: A systematic review and meta-analysis. PLoS Med. 2019 Sep 3;16(9):e1002890. doi: 10.1371/journal.pmed.1002890. eCollection 2019 Sep.
PubMed 31479454Hickin N, Kall A, Shafran R, Sutcliffe S, Manzotti G, Langan D. The effectiveness of psychological interventions for loneliness: A systematic review and meta-analysis. Clin Psychol Rev. 2021 Aug;88:102066. doi: 10.1016/j.cpr.2021.102066. Epub 2021 Jul 18.
PubMed 34339939Harada K, Masumoto K, Katagiri K, Fukuzawa A, Touyama M, Sonoda D, Chogahara M, Kondo N, Okada S. Three-year effects of neighborhood social network intervention on mental and physical health of older adults. Aging Ment Health. 2021 Dec;25(12):2235-2245. doi: 10.1080/13607863.2020.1839858. Epub 2020 Oct 29.
PubMed 33118392Fong P, Cruwys T, Robinson SL, Haslam SA, Haslam C, Mance PL, Fisher CL. Evidence that loneliness can be reduced by a whole-of-community intervention to increase neighbourhood identification. Soc Sci Med. 2021 May;277:113909. doi: 10.1016/j.socscimed.2021.113909. Epub 2021 Apr 6.
PubMed 33866082Ernst M, Niederer D, Werner AM, Czaja SJ, Mikton C, Ong AD, Rosen T, Brahler E, Beutel ME. Loneliness before and during the COVID-19 pandemic: A systematic review with meta-analysis. Am Psychol. 2022 Jul-Aug;77(5):660-677. doi: 10.1037/amp0001005. Epub 2022 May 9.
PubMed 35533109Cruwys T, Fong P, Evans O, Rathbone JA. A community-led intervention to build neighbourhood identification predicts better wellbeing following prolonged COVID-19 lockdowns. Front Psychol. 2022 Dec 9;13:1030637. doi: 10.3389/fpsyg.2022.1030637. eCollection 2022.
PubMed 36571042Creswell JD, Irwin MR, Burklund LJ, Lieberman MD, Arevalo JM, Ma J, Breen EC, Cole SW. Mindfulness-Based Stress Reduction training reduces loneliness and pro-inflammatory gene expression in older adults: a small randomized controlled trial. Brain Behav Immun. 2012 Oct;26(7):1095-101. doi: 10.1016/j.bbi.2012.07.006. Epub 2012 Jul 20.
PubMed 22820409Chung GK, Robinson M, Marmot M, Woo J. Monitoring socioeconomic inequalities in health in Hong Kong: insights and lessons from the UK and Australia. Lancet Reg Health West Pac. 2022 Nov 11;31:100636. doi: 10.1016/j.lanwpc.2022.100636. eCollection 2023 Feb.
PubMed 36879790
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviating Loneliness in Older Adults Living in Poverty: A Multi-level Intervention
- ClinicalTrials.gov ID
- NCT07123064
- Acronym / sponsor ID
- 2023-2024-0624
- Conditions
- Loneliness, Poverty
- Keywords
- Loneliness, Poverty, Cluster Randomized Controlled Trials, Older Adults, Mindfulness, SOLUS-D Programme, Group 4 Health, Neighbour Every Day
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,344 participants (estimated)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Collaborators
- University College, London, The Hong Kong Polytechnic University, University of Texas at Austin, Australian National University, The University of Hong Kong, Medical School Berlin, Chinese University of Hong Kong, University of Bern, Linkoeping University
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 14 Aug 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.
The study aims to reduce loneliness among Hong Kong Chinese older adults living in poverty with a multi-level intervention involving components at the individual, interpersonal, and community levels.
Detailed description
Loneliness is widespread, with negative impacts on both individuals and society and associated direct and indirect healthcare and long-term care costs. Thus, it is imperative to alleviate loneliness in old age by implementing effective, accessible, affordable, and scalable interventions. Loneliness is often erroneously considered an individual problem due to personal failure. Still, growing evidence indicates that loneliness is caused by factors at multiple levels, including the individual, interpersonal, and community levels. Hence, a multi-level approach is recommended to alleviate loneliness.
However, multi-level interventions for reducing loneliness are in their infancy, and there is yet to be evidence to suggest that they are more effective than single-level interventions. The investigators will conduct an innovative and impactful study to fill this important research gap. This study is a single-blinded cluster, four-arm randomized controlled trial (RCT) designed to test the effect and cost-effectiveness of a multi-level intervention to alleviate loneliness among Hong Kong Chinese older adults living in poverty. The investigators will also adopt the modified biopsychosocial (BPS) model, called the BPS-Pathways model, as the theoretical framework to guide our selection of interventions, mediators, secondary outcomes, long-term outcomes, and impact.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Single Blinded, 4-arm cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| First Arm | Experimental | Behavioral: Individual LevelIndividual-level |
| Second Arm | Experimental | Behavioral: Individual Level, Behavioral: Interpersonal LevelIndividual- and Interpersonal-level |
| Third Arm | Experimental | Behavioral: Individual Level, Behavioral: Interpersonal Level, Behavioral: Community LevelIndividual-, Interpersonal-, and Community-level |
| Forth Arm | Active comparator | Other: Education ControlEducation Control Group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- aged 65 years or older
- living in poverty (defined: inability to afford at least 5 items on the material deprivation index)
- proficiency in spoken Cantonese
- experiencing loneliness (defined: score of ≥ 6 on the 3-item UCLA Loneliness Scale)
Key exclusion criteria (3 listed)
- cognitive impairments, psychiatric disorders, learning disabilities, or active suicidal ideation
- actively participating in other psychotherapy or psychosocial interventions in the past 1 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 |
|---|---|---|
| Individual LevelA 8-weekly, 1hour telephone-delivered sessions using mindfulness and SOLUS-D program. Key contents include: introduction to mindfulness - Body awareness and present moment experiences, emotional awareness and mind-body labeling, relaxation techniques and sensory discrimination, deepening awareness and accepting feelings, personal values, interconnection between thought patterns and emotions, identifying and analyzing of thought traps, and challenging thoughts and future planning. Maintenance sessions which focus on embedding mindfulness practices and SOLUS-D program among older adults as a persistent habit will be conducted. | Behavioural | First Arm, Second Arm, Third Arm |
| Interpersonal LevelA 8 weekly, 1hr sessions through telephone or Zoom using the Group 4 Health. Key contents include: understanding the benefits of social connections, exploring self and community, community and action, support and breakthrough, summary and moving forward. Maintenance sessions which focus on continuous practice of support and community will be conducted. | Behavioural | Second Arm, Third Arm |
| Community LevelA 4 weekly, 2hour in-person sessions through (1) strengthening collective efficacy via neighbor identification with the community. Key contents include: building neighbourhood connections, getting to know each other, health aging, neighbourhood care, vibrant exploration, thriving community, connecting the dots. | Behavioural | Third Arm |
| Education ControlMonthly monthly messages via text, graphics or voice recordings will be sent over a period of 6 months. Key content includes: healthy diet tips, recognizing warning signs of health, understanding dementia, fall prevention tips, health message, and anti-fraud tips. | Other | Forth Arm |
Primary outcome
UCLA Loneliness Scale
Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month
The 20-item UCLA Loneliness Scale is a reliable self-assessment tool designed to evaluate feelings of loneliness. Each item will be rated from 1=Never to 4=Always. Total scores range from 20 to 80.
11 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month
Satisfaction with Life Scale
Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month
De Jong Gierveld Loneliness Scale
Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month
Lawton Instrumental Activities of Daily Living
Time frame: Baseline, 12-month, 24-month
Activities of Daily Living
Time frame: Baseline, 12-month, 24-month
Physical Symptoms Inventory
Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month
Charlson Comorbidity Index
Time frame: Baseline, 12-month, 24-month
Perceived Stress Scale
Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month
6-Minutes Walking Test
Time frame: Baseline, 12-month, 24-month
Hospital Anxiety and Depression Scale
Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month
Montreal Cognitive Assessment - Hong Kong
Time frame: Baseline, 12-month, 24-month
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 8 Jul 2026.
- Background: PubMed 35140066Surkalim DL, Luo M, Eres R, Gebel K, van Buskirk J, Bauman A, Ding D. The prevalence of loneliness across 113 countries: systematic review and meta-analysis. BMJ. 2022 Feb 9;376:e067068. doi: 10.1136/bmj-2021-067068.
- Background: PubMed 38885446Seguin-Fowler RA, Graham ML, Demment M, Uribe ALM, Rethorst CD, Szeszulski J. Multilevel Interventions Targeting Obesity: State of the Science and Future Directions. Annu Rev Nutr. 2024 Aug;44(1):357-381. doi: 10.1146/annurev-nutr-122123-020340. Epub 2024 Aug 12.
- Background: PubMed 26575604Santini ZI, Koyanagi A, Tyrovolas S, Haro JM, Fiori KL, Uwakwa R, Thiyagarajan JA, Webber M, Prince M, Prina AM. Social network typologies and mortality risk among older people in China, India, and Latin America: A 10/66 Dementia Research Group population-based cohort study. Soc Sci Med. 2015 Dec;147:134-43. doi: 10.1016/j.socscimed.2015.10.061. Epub 2015 Nov 4.
- Background: PubMed 20957426Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
- Background: PubMed 20716644Masi CM, Chen HY, Hawkley LC, Cacioppo JT. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66. doi: 10.1177/1088868310377394. Epub 2010 Aug 17.
- Background: PubMed 32469922Lloyd-Evans B, Frerichs J, Stefanidou T, Bone J, Pinfold V, Lewis G, Billings J, Barber N, Chhapia A, Chipp B, Henderson R, Shah P, Shorten A, Giorgalli M, Terhune J, Jones R, Johnson S. The Community Navigator Study: Results from a feasibility randomised controlled trial of a programme to reduce loneliness for people with complex anxiety or depression. PLoS One. 2020 May 29;15(5):e0233535. doi: 10.1371/journal.pone.0233535. eCollection 2020.
- Background: PubMed 37872618Lengnick-Hall R, Williams NJ, Ehrhart MG, Willging CE, Bunger AC, Beidas RS, Aarons GA. Eight characteristics of rigorous multilevel implementation research: a step-by-step guide. Implement Sci. 2023 Oct 23;18(1):52. doi: 10.1186/s13012-023-01302-2.
- Background: PubMed 31479454Hunter RF, de la Haye K, Murray JM, Badham J, Valente TW, Clarke M, Kee F. Social network interventions for health behaviours and outcomes: A systematic review and meta-analysis. PLoS Med. 2019 Sep 3;16(9):e1002890. doi: 10.1371/journal.pmed.1002890. eCollection 2019 Sep.
- Background: PubMed 34339939Hickin N, Kall A, Shafran R, Sutcliffe S, Manzotti G, Langan D. The effectiveness of psychological interventions for loneliness: A systematic review and meta-analysis. Clin Psychol Rev. 2021 Aug;88:102066. doi: 10.1016/j.cpr.2021.102066. Epub 2021 Jul 18.
- Background: PubMed 33118392Harada K, Masumoto K, Katagiri K, Fukuzawa A, Touyama M, Sonoda D, Chogahara M, Kondo N, Okada S. Three-year effects of neighborhood social network intervention on mental and physical health of older adults. Aging Ment Health. 2021 Dec;25(12):2235-2245. doi: 10.1080/13607863.2020.1839858. Epub 2020 Oct 29.
- Background: PubMed 33866082Fong P, Cruwys T, Robinson SL, Haslam SA, Haslam C, Mance PL, Fisher CL. Evidence that loneliness can be reduced by a whole-of-community intervention to increase neighbourhood identification. Soc Sci Med. 2021 May;277:113909. doi: 10.1016/j.socscimed.2021.113909. Epub 2021 Apr 6.
- Background: PubMed 35533109Ernst M, Niederer D, Werner AM, Czaja SJ, Mikton C, Ong AD, Rosen T, Brahler E, Beutel ME. Loneliness before and during the COVID-19 pandemic: A systematic review with meta-analysis. Am Psychol. 2022 Jul-Aug;77(5):660-677. doi: 10.1037/amp0001005. Epub 2022 May 9.
- Individual participant dataSharing planned: No
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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.
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 Individual Level, Interpersonal Level and Community Level in people with Loneliness and Poverty, 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: looking for participants now, as of the sponsor's last update on 8 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA Loneliness Scale (time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07123064, which also lists 18 linked publications.
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 8 Jul 2026.