NCT07021872

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jun 2025Nov 2026

First Submitted

Initial submission to the registry

June 6, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

June 6, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

LonelinessOlder AdultsPositive AffectBehavioral ActivationRandomized Controlled Trials

Outcome Measures

Primary Outcomes (3)

  • Loneliness measured by the UCLA Loneliness Scale

    The UCLA Loneliness Scale is a reliable self-assessment tool designed to evaluate feelings of loneliness. Possible scores range from 1 (never) to 4 (always).

    Baseline, 3-month, and 6-month

  • Loneliness measured by De Jong Gierveld Loneliness Scale

    The De Jong Gierveld Loneliness Scale is a validated, self-reported instrument assessing loneliness. Possible scores range from 1 (yes) to 3 (no).

    Baseline, 3-month, and 6-month

  • Real-time Experiences on Ecological Momentary Assessment

    Ecological Momentary Assessment (EMA) is a research method used to collect data in real-time and in the participants' natural environments. It measures momentary loneliness, momentary actual affect examined by the short version of the AVI scale, current and expected locations (e.g., nature, home, public places), as well as details about their current and expected social interactions, including the type (i.e., alone, with spouse, family members), features (e.g., supportiveness, closeness, pleasantness, meaningfulness), and number (i.e., 0, 1, 2, 3, 4, 5, or more than 5). Participants will also report on their current and expected activities, specifying the type (e.g., physical activity, working, cognitive activities) and characteristics (e.g., pleasantness, meaningfulness) of these activities.

    Baseline and 2-week

Secondary Outcomes (7)

  • Psychological Well-being on 6-point Psychological Well-being Scale

    Baseline, 3-month, and 6-month

  • Perceived Stress on 5-point Chinese Version of the Perceived Stress Scale

    Baseline, 3-month, and 6-month

  • Symptoms of Depression on 4-point Chinese Version of Patient Health Questionnaire-9 (PHQ-9)

    Baseline, 3-month, and 6-month

  • Symptoms of Anxiety on 4-point Chinese Version of the Generalized Anxiety Disorder Scale

    Baseline, 3-month, and 6-month

  • Cognitive Functioning on the Hong Kong Version of Montreal Cognitive Assessment

    Baseline, 3-month, and 6-month

  • +2 more secondary outcomes

Other Outcomes (7)

  • Affective Experience over the Past Week on 30-item Affect Valuation Index (actual affect) (AVI)

    Baseline, 3-month, and 6-month

  • Social Network Characteristics on 10-point Social Network Characteristics Scale

    Baseline, 3-month, and 6-month

  • Meaning of Life on 7-point Meaning in Life Questionnaire (MLQ)

    Baseline, 3-month, and 6-month

  • +4 more other outcomes

Study Arms (3)

Positive Affect

EXPERIMENTAL

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.

Behavioral: Tele-Positive Affect Intervention

Behavioral Activation

EXPERIMENTAL

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.

Behavioral: Tele-Behavioral Activation Intervention

Friendly Visit

ACTIVE COMPARATOR

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

Behavioral: Tele-Friendly Visit

Interventions

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.

Positive Affect

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.

Behavioral Activation

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.

Friendly Visit

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

RECRUITING

Related Publications (38)

  • 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.

    PMID: 21193179BACKGROUND
  • 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.

    PMID: 19672065BACKGROUND
  • 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.

    PMID: 10568646BACKGROUND
  • 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.

    PMID: 7473027BACKGROUND
  • 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.

    PMID: 33981167BACKGROUND
  • 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.

    PMID: 28982660BACKGROUND
  • 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.

    PMID: 15817019BACKGROUND
  • 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.

    PMID: 22021272BACKGROUND
  • 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.

    PMID: 31045422BACKGROUND
  • 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.

    PMID: 28333512BACKGROUND
  • 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.

    PMID: 11811629BACKGROUND
  • 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.

    PMID: 16921004BACKGROUND
  • 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.

    PMID: 30550321BACKGROUND
  • 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.

    PMID: 30808743BACKGROUND
  • 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.

    PMID: 18590603BACKGROUND
  • 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.

    PMID: 20735860BACKGROUND
  • 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.

    PMID: 21324944BACKGROUND
  • 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.

    PMID: 39149879BACKGROUND
  • 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.

    PMID: 26214569BACKGROUND
  • 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.

    PMID: 33284976BACKGROUND
  • 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.

    PMID: 23596271BACKGROUND
  • 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.

    PMID: 16952717BACKGROUND
  • 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.

    PMID: 12916575BACKGROUND
  • Folkman S. The case for positive emotions in the stress process. Anxiety Stress Coping. 2008 Jan;21(1):3-14. doi: 10.1080/10615800701740457.

    PMID: 18027121BACKGROUND
  • 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.

    PMID: 9381234BACKGROUND
  • Ferster CB. A functional anlysis of depression. Am Psychol. 1973 Oct;28(10):857-70. doi: 10.1037/h0035605. No abstract available.

    PMID: 4753644BACKGROUND
  • 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.

    PMID: 12382592BACKGROUND
  • 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.

    PMID: 34887211BACKGROUND
  • 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.

    PMID: 34375898BACKGROUND
  • 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.

    PMID: 25214877BACKGROUND
  • 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.

    PMID: 15804635BACKGROUND
  • 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.

    PMID: 32238297BACKGROUND
  • 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.

    PMID: 27862646BACKGROUND
  • 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.

    PMID: 30071067BACKGROUND
  • 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.

    PMID: 25866548BACKGROUND
  • 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.

    PMID: 16443717BACKGROUND
  • 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.

    PMID: 17114313BACKGROUND
  • 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.

    PMID: 36322145BACKGROUND

Study Officials

  • Da Jiang, PhD

    The Education University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Da Jiang, PhD

CONTACT

Xinyuan Peng, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A three-armed randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 6, 2025

First Posted

June 15, 2025

Study Start

June 30, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations