Alleviating Loneliness in Older Adults Living in Poverty: A Multi-level Intervention
NCT ID: NCT07123064
Last Updated: 2025-12-12
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
1344 participants
INTERVENTIONAL
2025-12-15
2029-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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First Arm
Individual-level
Individual Level
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.
Second Arm
Individual- and Interpersonal-level
Individual Level
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 Level
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.
Third Arm
Individual-, Interpersonal-, and Community-level
Individual Level
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 Level
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 Level
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.
Forth Arm
Education Control Group
Education Control
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.
Interventions
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Individual Level
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 Level
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 Level
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 Control
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* actively participating in other psychotherapy or psychosocial interventions in the past 1 year
\-
65 Years
ALL
Yes
Sponsors
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University College, London
OTHER
The Hong Kong Polytechnic University
OTHER
University of Texas at Austin
OTHER
Australian National University
OTHER
The University of Hong Kong
OTHER
Medical School Berlin
OTHER
Chinese University of Hong Kong
OTHER
University of Bern
OTHER
Linkoeping University
OTHER_GOV
Education University of Hong Kong
OTHER
Responsible Party
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Chou Kee Lee
Chair Professor of Social Policy
Principal Investigators
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Kee Lee Chou, PhD
Role: PRINCIPAL_INVESTIGATOR
The Education University of Hong Kong
Locations
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The Education University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Facility Contacts
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References
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Hickin 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.
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.
Seguin-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.
Santini 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.
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Masi 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.
Lloyd-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.
Lengnick-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.
Hunter 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.
Harada 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.
Fong 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.
Ernst 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.
Cruwys 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.
Creswell 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.
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Other Identifiers
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R8002-24
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2023-2024-0624
Identifier Type: -
Identifier Source: org_study_id
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