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LonelinessNCT07021872

Reducing Loneliness Among Older Adults Through Enhancing Positive Affect

A study testing Tele-Positive Affect Intervention, Tele-Behavioral Activation Intervention and Tele-Friendly Visit in people with Loneliness, run by Education University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Loneliness
What is being tested?
Tele-Positive Affect Intervention, Tele-Behavioral Activation Intervention and Tele-Friendly Visit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
1 siteHong Kong
Study dates
30 Jun 2025to 30 Nov 2026
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
  • proficiency in Cantonese (over telephone)
  • experiencing loneliness (defined as a score of ≥ 6 on the 3-item UCLA Loneliness Scale)

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Da Jiang, PhD contact

852 2948 8659

djiang@eduhk.hk

Xinyuan Peng, MSc contact

85229487138

s1147990@s.eduhk.hk

Hong Kong1 site, 1 recruiting
  • The Education University of Hong Kong

    Hong Kong, Hong Kong

    Da Jiang, PhD, +85229488659, djiang@eduhk.hk

    Xinyuan Peng, MSc, 85229487138, s1147990@s.eduhk.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Reducing Loneliness Among Older Adults Through Enhancing Positive Affect: A Randomized Controlled Trial With Ecological Momentary Assessments

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.

Read the detailed description

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
Loneliness
Being tested
Tele-Positive Affect Intervention, Tele-Behavioral Activation Intervention, Tele-Friendly Visit
Keywords
Loneliness, Older Adults, Positive Affect, Behavioral Activation, Randomized Controlled Trials

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-Positive Affect InterventionBehavioural

    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.

  • Tele-Behavioral Activation InterventionBehavioural

    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.

  • Tele-Friendly VisitBehavioural

    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.

Study groups in NCT07021872
Study groupRoleWhat they receive
Positive AffectExperimentalParticipants in the Positive Affect group will receive the Tele-PA Intervention to test the effects of the intervention in reducing loneliness among older adults.
Receives: Behavioral: Tele-Positive Affect Intervention
Behavioral ActivationExperimentalParticipants in the Behavioral Activation group will receive the Tele-BA Intervention to test the effects of the intervention in reducing loneliness among older adults.
Receives: Behavioral: Tele-Behavioral Activation Intervention
Friendly VisitActive comparatorParticipants in the Friendly Visit group will receive the Tele-FV Intervention as an active control.
Receives: Behavioral: Tele-Friendly Visit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, 3-month, and 6-month

  2. 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).

    Measured: Baseline, 3-month, and 6-month

  3. 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.

    Measured: Baseline and 2-week

Secondary outcomes (7)
  1. Psychological Well-being on 6-point Psychological Well-being Scale

    The Psychological Well-being Scale is a validated, self-reported instrument assessing Psychological Well-being. Possible scores range from 1 (strongly disagree) to 6 (strongly agree).

    Measured: Baseline, 3-month, and 6-month

  2. Perceived Stress on 5-point Chinese Version of the Perceived Stress Scale

    The Chinese version of the Perceived Stress Scale is a validated self-report tool used to measure Perceived Stress levels. Possible scores range from 0 (never) to 4 (very often).

    Measured: Baseline, 3-month, and 6-month

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

    PHQ-9 is a reliable self-report measure designed to evaluate Symptoms of depression. Possible scores range from 0 (not at all) to 3 (nearly everyday).

    Measured: Baseline, 3-month, and 6-month

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

    The Chinese version of the Generalized Anxiety Disorder Scale is a validated, self-reported instrument assessing Symptoms of depression. Possible scores range from 0 (not feeling at all) to 3 (most of the time).

    Measured: Baseline, 3-month, and 6-month

  5. Cognitive Functioning on the Hong Kong Version of Montreal Cognitive Assessment

    The Hong Kong version of the Montreal Cognitive Assessment (MoCA-HK) is a validated tool administered by clinicians to evaluate cognitive functioning, especially in older adults. Possible scores range from 0 to 30, with higher scores indicating better cognitive performance.

    Measured: Baseline, 3-month, and 6-month

  6. Perceived Social Support on 7-point Multidimensional Scale of Perceived Social Support

    The Multidimensional Scale of Perceived Social Support evaluates the social support derived from three key sources: family, friends, and significant others. Respondents rated each item on a 7-point Likert scale, where 1 represents "very strongly disagree" and 7 indicates "very strongly agree."

    Measured: Baseline, 3-month, and 6-month

  7. Social Network on Lubben Social Network Scale at Month 3 and Month 6

    The Lubben Social Network Scale is a validated, self-reported instrument assessing the social networks of participants. This scale comprises six items, with three focused on family connections (family subscale) and three addressing friendships (friend subscale). The overall score ranges from 0 to 30, with each subscale spanning from 0 to 15.

    Measured: Baseline, 3-month, and 6-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2025
  2. Study start30 Jun 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

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
A three-armed randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
276 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07021872
Sponsor's protocol ID
2023-2024-0179
Status last verified
Jul 2025
First submitted
6 Jun 2025
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21193179
  • 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.

    PubMed 19672065
  • 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.

    PubMed 10568646
  • 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.

    PubMed 7473027
  • 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.

    PubMed 33981167
  • 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.

    PubMed 28982660
  • 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.

    PubMed 15817019
  • 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.

    PubMed 22021272
  • 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.

    PubMed 31045422
  • 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.

    PubMed 28333512
  • 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.

    PubMed 11811629
  • 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.

    PubMed 16921004
  • 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.

    PubMed 30550321
  • 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.

    PubMed 30808743
  • 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.

    PubMed 18590603

Questions about this trial

What is this clinical trial studying?

A study testing Tele-Positive Affect Intervention, Tele-Behavioral Activation Intervention and Tele-Friendly Visit in people with Loneliness, 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 3 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 17 Jul 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?

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?

Contact Da Jiang, PhD (852 2948 8659, djiang@eduhk.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loneliness measured by the UCLA Loneliness Scale (time frame: Baseline, 3-month, and 6-month). The study lists 3 primary outcomes in all. 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 NCT07021872, which also lists 38 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 17 Jul 2025.

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