Reducing Loneliness Among Older Adults Through Enhancing Positive Affect

NCT ID: NCT07021872

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-11-30

Brief Summary

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This study aims to evaluate the effectiveness of two psychosocial interventions-Tele-Positive Affect (Tele-PA) and Tele-Behavioral Activation (Tele-BA)-compared to active control (telephone-delivered friendly visit, Tele-FV) in reducing loneliness among older adults in Hong Kong.

Detailed Description

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Loneliness in older adults represents a critical public health challenge, associated with detrimental outcomes including depression, cardiovascular risks, cognitive decline, and elevated mortality. Despite existing interventions, significant gaps persist: most approaches neglect the affective dimension of loneliness, fail to address the core mechanism of perceived discrepancies between expected and actual social relationships, and inadequately account for age-related shifts in socioemotional goals. This randomized controlled trial addresses these limitations by evaluating two theoretically distinct telephone-delivered psychosocial interventions against an active comparator.

The study employs a three-arm design to compare a 4-week Tele-Positive Affect (Tele-PA) intervention grounded in the broaden-and-build theory of positive emotion, which aims at increasing positive affect through eight evidence-based skills (e.g., gratitude, mindfulness, positive reappraisal), and a Tele-Behavioral Activation (Tele-BA) intervention derived from the behavioral explanations of learning theory, focusing on behavior monitoring and strategies, valued activity scheduling, and social skill enhancement. Both are contrasted with Tele-Friendly Visit (FV)-an active control condition comprising matched-frequency neutral conversations devoid of therapeutic components.

Community-dwelling adults aged ≥65 years in Hong Kong with significant loneliness will be randomized to these arms. Using a three-arm, assessor-blinded randomized clinical trial, outcomes will be measured through retrospective surveys and ecological momentary assessments (EMA) at baseline, immediately post-intervention (Week 2), and at 3- and 6-month follow-ups. Primary analyses will examine: 1) the comparative efficacy of Tele-PA and Tele-BA versus the active control in reducing loneliness; 2) differential effectiveness of Tele-PA versus Tele-BA; 3) the mechanisms underlying the effects of Tele-PA and Tele-BA; and 4) the effects of age on the effectiveness.

This research pioneers the integration of affective science with loneliness intervention design while employing EMA to capture mechanistic dynamics. Findings will advance precision approaches for alleviating loneliness in aging populations through scalable, theory-informed strategies.

Conditions

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Loneliness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A three-armed randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Positive Affect

Participants in the Positive Affect group will receive the Tele-PA Intervention to test the effects of the intervention in reducing loneliness among older adults.

Group Type EXPERIMENTAL

Tele-Positive Affect Intervention

Intervention Type BEHAVIORAL

A 4-week intervention consisting of eight skills aimed at enhancing positive affect, delivered via telephone by trained facilitators. Participants will learn skills such as gratitude, mindfulness, and positive reappraisal, with sessions held twice a week.

Behavioral Activation

Participants in the Behavioral Activation group will receive the Tele-BA Intervention to test the effects of the intervention in reducing loneliness among older adults.

Group Type EXPERIMENTAL

Tele-Behavioral Activation Intervention

Intervention Type BEHAVIORAL

A 4-week intervention designed to promote engagement in meaningful activities, delivered through telephone by trained facilitators. The intervention will include behavior monitoring, activity planning, and social skills enhancement, with sessions held twice a week.

Friendly Visit

Participants in the Friendly Visit group will receive the Tele-FV Intervention as an active control.

Group Type ACTIVE_COMPARATOR

Tele-Friendly Visit

Intervention Type BEHAVIORAL

An active control condition consisting of telephone-delivered friendly visits. Participants will engage in social conversation and activities to provide companionship without any specific skills training aimed at reducing loneliness. The intervention will be held within 4-week.

Interventions

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Tele-Positive Affect Intervention

A 4-week intervention consisting of eight skills aimed at enhancing positive affect, delivered via telephone by trained facilitators. Participants will learn skills such as gratitude, mindfulness, and positive reappraisal, with sessions held twice a week.

Intervention Type BEHAVIORAL

Tele-Behavioral Activation Intervention

A 4-week intervention designed to promote engagement in meaningful activities, delivered through telephone by trained facilitators. The intervention will include behavior monitoring, activity planning, and social skills enhancement, with sessions held twice a week.

Intervention Type BEHAVIORAL

Tele-Friendly Visit

An active control condition consisting of telephone-delivered friendly visits. Participants will engage in social conversation and activities to provide companionship without any specific skills training aimed at reducing loneliness. The intervention will be held within 4-week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* aged 65 years or older
* proficiency in Cantonese (over telephone)
* experiencing loneliness (defined as a score of ≥ 6 on the 3-item UCLA Loneliness Scale)

Exclusion Criteria

* cognitive impairments
* psychiatric disorders, learning disabilities, or active suicidal ideation
* currently participating in other psychotherapy or psychosocial interventions aimed at enhancing well-being
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role collaborator

City University of Hong Kong

OTHER

Sponsor Role collaborator

Education University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Jiang Da

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Da Jiang, 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, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Da Jiang, PhD

Role: CONTACT

852 2948 8659

Xinyuan Peng, MSc

Role: CONTACT

85229487138

Facility Contacts

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Da Jiang, PhD

Role: primary

+85229488659

Xinyuan Peng, MSc

Role: backup

85229487138

References

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Yu X, Tam WW, Wong PT, Lam TH, Stewart SM. The Patient Health Questionnaire-9 for measuring depressive symptoms among the general population in Hong Kong. Compr Psychiatry. 2012 Jan;53(1):95-102. doi: 10.1016/j.comppsych.2010.11.002. Epub 2010 Dec 28.

Reference Type BACKGROUND
PMID: 21193179 (View on PubMed)

Wong A, Xiong YY, Kwan PW, Chan AY, Lam WW, Wang K, Chu WC, Nyenhuis DL, Nasreddine Z, Wong LK, Mok VC. The validity, reliability and clinical utility of the Hong Kong Montreal Cognitive Assessment (HK-MoCA) in patients with cerebral small vessel disease. Dement Geriatr Cogn Disord. 2009;28(1):81-7. doi: 10.1159/000232589. Epub 2009 Aug 11.

Reference Type BACKGROUND
PMID: 19672065 (View on PubMed)

Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.

Reference Type BACKGROUND
PMID: 10568646 (View on PubMed)

Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719-27. doi: 10.1037//0022-3514.69.4.719.

Reference Type BACKGROUND
PMID: 7473027 (View on PubMed)

Verstaen A, Moskowitz JT, Snowberg KE, Merrilees J, Dowling GA. Life Enhancing Activities for Family Caregivers of people with dementia: protocol for a randomized controlled trial of a positive affect skills intervention. Open Access J Clin Trials. 2018;10:1-12. doi: 10.2147/oajct.s150597. Epub 2018 Feb 7.

Reference Type BACKGROUND
PMID: 33981167 (View on PubMed)

Orgeta V, Brede J, Livingston G. Behavioural activation for depression in older people: systematic review and meta-analysis. Br J Psychiatry. 2017 Nov;211(5):274-279. doi: 10.1192/bjp.bp.117.205021. Epub 2017 Oct 5.

Reference Type BACKGROUND
PMID: 28982660 (View on PubMed)

Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

Reference Type BACKGROUND
PMID: 15817019 (View on PubMed)

Moskowitz JT, Hult JR, Duncan LG, Cohn MA, Maurer S, Bussolari C, Acree M. A positive affect intervention for people experiencing health-related stress: development and non-randomized pilot test. J Health Psychol. 2012 Jul;17(5):676-92. doi: 10.1177/1359105311425275. Epub 2011 Oct 21.

Reference Type BACKGROUND
PMID: 22021272 (View on PubMed)

Moskowitz JT, Cheung EO, Snowberg KE, Verstaen A, Merrilees J, Salsman JM, Dowling GA. Randomized controlled trial of a facilitated online positive emotion regulation intervention for dementia caregivers. Health Psychol. 2019 May;38(5):391-402. doi: 10.1037/hea0000680.

Reference Type BACKGROUND
PMID: 31045422 (View on PubMed)

Moskowitz JT, Carrico AW, Duncan LG, Cohn MA, Cheung EO, Batchelder A, Martinez L, Segawa E, Acree M, Folkman S. Randomized controlled trial of a positive affect intervention for people newly diagnosed with HIV. J Consult Clin Psychol. 2017 May;85(5):409-423. doi: 10.1037/ccp0000188. Epub 2017 Mar 23.

Reference Type BACKGROUND
PMID: 28333512 (View on PubMed)

Mccullough ME, Emmons RA, Tsang JA. The grateful disposition: a conceptual and empirical topography. J Pers Soc Psychol. 2002 Jan;82(1):112-27. doi: 10.1037//0022-3514.82.1.112.

Reference Type BACKGROUND
PMID: 11811629 (View on PubMed)

Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, Stuck AE. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006 Aug;46(4):503-13. doi: 10.1093/geront/46.4.503.

Reference Type BACKGROUND
PMID: 16921004 (View on PubMed)

Lindsay EK, Chin B, Greco CM, Young S, Brown KW, Wright AGC, Smyth JM, Burkett D, Creswell JD. How mindfulness training promotes positive emotions: Dismantling acceptance skills training in two randomized controlled trials. J Pers Soc Psychol. 2018 Dec;115(6):944-973. doi: 10.1037/pspa0000134.

Reference Type BACKGROUND
PMID: 30550321 (View on PubMed)

Lindsay EK, Young S, Brown KW, Smyth JM, Creswell JD. Mindfulness training reduces loneliness and increases social contact in a randomized controlled trial. Proc Natl Acad Sci U S A. 2019 Feb 26;116(9):3488-3493. doi: 10.1073/pnas.1813588116. Epub 2019 Feb 11.

Reference Type BACKGROUND
PMID: 30808743 (View on PubMed)

Leung GT, de Jong Gierveld J, Lam LC. Validation of the Chinese translation of the 6-item De Jong Gierveld Loneliness Scale in elderly Chinese. Int Psychogeriatr. 2008 Dec;20(6):1262-72. doi: 10.1017/S1041610208007552. Epub 2008 Jul 1.

Reference Type BACKGROUND
PMID: 18590603 (View on PubMed)

Leung DY, Lam TH, Chan SS. Three versions of Perceived Stress Scale: validation in a sample of Chinese cardiac patients who smoke. BMC Public Health. 2010 Aug 25;10:513. doi: 10.1186/1471-2458-10-513.

Reference Type BACKGROUND
PMID: 20735860 (View on PubMed)

Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.

Reference Type BACKGROUND
PMID: 21324944 (View on PubMed)

Lay JC, Ho YW, Tse DCK, Tse JTK, Jiang D. Misremembering Solitude: The Role of Personality and Cultural Self-Concepts in Shaping Discrepancies Between Recalled and Concurrent Affect in Solitude. J Pers. 2025 Feb;93(1):174-192. doi: 10.1111/jopy.12971. Epub 2024 Aug 16.

Reference Type BACKGROUND
PMID: 39149879 (View on PubMed)

Jiang D, Fung HH, Sims T, Tsai JL, Zhang F. Limited time perspective increases the value of calm. Emotion. 2016 Feb;16(1):52-62. doi: 10.1037/emo0000094. Epub 2015 Jul 27.

Reference Type BACKGROUND
PMID: 26214569 (View on PubMed)

Jiang D. Feeling Gratitude Is Associated With Better Well-being Across the Life Span: A Daily Diary Study During the COVID-19 Outbreak. J Gerontol B Psychol Sci Soc Sci. 2022 Apr 1;77(4):e36-e45. doi: 10.1093/geronb/gbaa220.

Reference Type BACKGROUND
PMID: 33284976 (View on PubMed)

Hou J, Wong SY, Lo HH, Mak WW, Ma HS. Validation of a Chinese version of the Five Facet Mindfulness Questionnaire in Hong Kong and development of a short form. Assessment. 2014 Jun;21(3):363-71. doi: 10.1177/1073191113485121. Epub 2013 Apr 16.

Reference Type BACKGROUND
PMID: 23596271 (View on PubMed)

Heinrich LM, Gullone E. The clinical significance of loneliness: a literature review. Clin Psychol Rev. 2006 Oct;26(6):695-718. doi: 10.1016/j.cpr.2006.04.002. Epub 2006 Jun 19.

Reference Type BACKGROUND
PMID: 16952717 (View on PubMed)

Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.

Reference Type BACKGROUND
PMID: 12916575 (View on PubMed)

Folkman S. The case for positive emotions in the stress process. Anxiety Stress Coping. 2008 Jan;21(1):3-14. doi: 10.1080/10615800701740457.

Reference Type BACKGROUND
PMID: 18027121 (View on PubMed)

Folkman S. Positive psychological states and coping with severe stress. Soc Sci Med. 1997 Oct;45(8):1207-21. doi: 10.1016/s0277-9536(97)00040-3.

Reference Type BACKGROUND
PMID: 9381234 (View on PubMed)

Ferster CB. A functional anlysis of depression. Am Psychol. 1973 Oct;28(10):857-70. doi: 10.1037/h0035605. No abstract available.

Reference Type BACKGROUND
PMID: 4753644 (View on PubMed)

Fees BS, Martin P, Poon LW. A model of loneliness in older adults. J Gerontol B Psychol Sci Soc Sci. 1999 Jul;54(4):P231-9. doi: 10.1093/geronb/54b.4.p231.

Reference Type BACKGROUND
PMID: 12382592 (View on PubMed)

Davidson EJ, Taylor CT, Ayers CR, Quach NE, Tu XM, Lee EE. The Relationship Between Loneliness and Positive Affect in Older Adults. Am J Geriatr Psychiatry. 2022 Jun;30(6):678-685. doi: 10.1016/j.jagp.2021.11.002. Epub 2021 Nov 12.

Reference Type BACKGROUND
PMID: 34887211 (View on PubMed)

Compernolle EL, Finch LE, Hawkley LC, Cagney KA. Momentary loneliness among older adults: Contextual differences and their moderation by gender and race/ethnicity. Soc Sci Med. 2021 Sep;285:114307. doi: 10.1016/j.socscimed.2021.114307. Epub 2021 Aug 6.

Reference Type BACKGROUND
PMID: 34375898 (View on PubMed)

Cohn MA, Pietrucha ME, Saslow LR, Hult JR, Moskowitz JT. An online positive affect skills intervention reduces depression in adults with type 2 diabetes. J Posit Psychol. 2014 Jan 1;9(6):523-534. doi: 10.1080/17439760.2014.920410.

Reference Type BACKGROUND
PMID: 25214877 (View on PubMed)

Chou KL, Jun LW, Chi I. Assessing Chinese older adults' suicidal ideation: Chinese version of the Geriatric Suicide Ideation Scale. Aging Ment Health. 2005 Mar;9(2):167-71. doi: 10.1080/13607860412331336805.

Reference Type BACKGROUND
PMID: 15804635 (View on PubMed)

Choi NG, Pepin R, Marti CN, Stevens CJ, Bruce ML. Improving Social Connectedness for Homebound Older Adults: Randomized Controlled Trial of Tele-Delivered Behavioral Activation Versus Tele-Delivered Friendly Visits. Am J Geriatr Psychiatry. 2020 Jul;28(7):698-708. doi: 10.1016/j.jagp.2020.02.008. Epub 2020 Mar 2.

Reference Type BACKGROUND
PMID: 32238297 (View on PubMed)

Cheung EO, Cohn MA, Dunn LB, Melisko ME, Morgan S, Penedo FJ, Salsman JM, Shumay DM, Moskowitz JT. A randomized pilot trial of a positive affect skill intervention (lessons in linking affect and coping) for women with metastatic breast cancer. Psychooncology. 2017 Dec;26(12):2101-2108. doi: 10.1002/pon.4312. Epub 2016 Dec 27.

Reference Type BACKGROUND
PMID: 27862646 (View on PubMed)

Chang Q, Sha F, Chan CH, Yip PSF. Validation of an abbreviated version of the Lubben Social Network Scale ("LSNS-6") and its associations with suicidality among older adults in China. PLoS One. 2018 Aug 2;13(8):e0201612. doi: 10.1371/journal.pone.0201612. eCollection 2018.

Reference Type BACKGROUND
PMID: 30071067 (View on PubMed)

Cacioppo S, Grippo AJ, London S, Goossens L, Cacioppo JT. Loneliness: clinical import and interventions. Perspect Psychol Sci. 2015 Mar;10(2):238-49. doi: 10.1177/1745691615570616.

Reference Type BACKGROUND
PMID: 25866548 (View on PubMed)

Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

Reference Type BACKGROUND
PMID: 16443717 (View on PubMed)

Barg FK, Huss-Ashmore R, Wittink MN, Murray GF, Bogner HR, Gallo JJ. A mixed-methods approach to understanding loneliness and depression in older adults. J Gerontol B Psychol Sci Soc Sci. 2006 Nov;61(6):S329-39. doi: 10.1093/geronb/61.6.s329.

Reference Type BACKGROUND
PMID: 17114313 (View on PubMed)

Akhter-Khan SC, Prina M, Wong GH, Mayston R, Li L. Understanding and Addressing Older Adults' Loneliness: The Social Relationship Expectations Framework. Perspect Psychol Sci. 2023 Jul;18(4):762-777. doi: 10.1177/17456916221127218. Epub 2022 Nov 2.

Reference Type BACKGROUND
PMID: 36322145 (View on PubMed)

Other Identifiers

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2023-2024-0179

Identifier Type: -

Identifier Source: org_study_id

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