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NCT Number: NCT07021872

Reducing Loneliness Among Older Adults Through Enhancing Positive Affect

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele-Positive Affect Intervention

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.

Tele-Behavioral Activation Intervention

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.

Tele-Friendly Visit

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.

Primary outcomes

  1. Loneliness measured by the UCLA Loneliness Scale

    Time frame: Baseline, 3-month, and 6-month

    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).

  2. Loneliness measured by De Jong Gierveld Loneliness Scale

    Time frame: Baseline, 3-month, and 6-month

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

  3. Real-time Experiences on Ecological Momentary Assessment

    Time frame: Baseline and 2-week

    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.

Secondary outcomes

  1. Psychological Well-being on 6-point Psychological Well-being Scale

    Time frame: Baseline, 3-month, and 6-month

    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).

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

    Time frame: Baseline, 3-month, and 6-month

    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).

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

    Time frame: Baseline, 3-month, and 6-month

    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).

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

    Time frame: Baseline, 3-month, and 6-month

    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).

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

    Time frame: Baseline, 3-month, and 6-month

    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.

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

    Time frame: Baseline, 3-month, and 6-month

    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."

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

    Time frame: Baseline, 3-month, and 6-month

    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.

Other outcomes

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

    Time frame: Baseline, 3-month, and 6-month

    The Affect Valuation Index (AVI) is a validated, self-reported instrument assessing affective experiences over the past week. It evaluates both the actual emotions experienced and the ideal emotions valued by the individual. Possible scores for each emotion reflect the frequency of experience, typically ranging from 1 (very slightly or not at all) to 5 (extremely or all the time).

  2. Social Network Characteristics on 10-point Social Network Characteristics Scale

    Time frame: Baseline, 3-month, and 6-month

    The Social Network Characteristics Scale will assess the perceived supportiveness, closeness, pleasantness, and meaningfulness of participants' social partners over the past two weeks. Possible scores range from 1 (not at all) to 10 (extremely high). Additionally, participants will report the number of social partners they have engaged with during this same timeframe.

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

    Time frame: Baseline, 3-month, and 6-month

    The MLQ is a reliable self-assessment tool that evaluates individuals' sense of meaning in life. This instrument comprises two subscales: Presence of Meaning and Search for Meaning, with each subscale containing five items. Each subscale has a minimum score of 5 and a maximum score of 35.

  4. Gratitude on 7-point Gratitude Scale Questionnaire-Six Item Form (GQ-6)

    Time frame: Baseline, 3-month, and 6-month

    The GQ-6 is a validated self-report measure that evaluates inclination to recognize, appreciate, and respond to life events with gratitude. Possible scores range from 1 (strongly disagree) to 7 (strongly agree).

  5. Cognitive Reappraisal on 7-point Emotional Regulation Questionnaire (ERQ)

    Time frame: Baseline, 3-month, and 6-month

    The ERQ is a validated, self-reported instrument assessing emotional regulation strategies, specifically cognitive reappraisal (6 items) and expressive suppression (4 items). Possible scores range from 1 (strongly disagree) to 7 (strongly agree).

  6. Self-Efficacy on 4-point General Self-Efficacy Scale (GSE)

    Time frame: Baseline, 3-month, and 6-month

    The GSE is a validated instrument assessing participants' self-reported levels of self-efficacy. This validated instrument consists of 10 items designed to measure individuals' optimistic beliefs regarding their capacity to manage challenging situations. Participants will evaluate each statement using a 4-point Likert scale, where 1 indicates "not at all true" and 4 represents "exactly true."

  7. Mindfulness on 5-point Five Facet Mindfulness Questionnaire

    Time frame: Baseline, 3-month, and 6-month

    The Five Facet Mindfulness Questionnaire is a validated measure assessing levels of mindfulness. Responses will be scored on a 5-point Likert scale, ranging from 1 (never or very rarely true) to 5 (very often or always true).

Study contacts

Contact information is provided by the study sponsor or research team.

Da Jiang, PhD

CONTACT

[email protected]

852 2948 8659

Xinyuan Peng, MSc

CONTACT

[email protected]

85229487138

Sponsors and collaborators

Lead sponsor

Education University of Hong Kong

Other

Collaborators

  • City University of Hong Kong
  • University of Texas at Austin

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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