Reducing Loneliness Among Older Adults Through Enhancing Positive Affect

Not Applicable

Recruiting

• Conditions: Loneliness

• Registration Number: NCT07021872
• Lead Sponsor: Education University of Hong Kong

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.

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.

Study Timeline

• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-06
• Study First Posted: 2025-06-15
• Study Start: 2025-06-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 276

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Loneliness measured by the UCLA Loneliness Scale	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).
Loneliness measured by De Jong Gierveld Loneliness Scale	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).
Real-time Experiences on Ecological Momentary Assessment	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 Outcome Measures

Name	Time	Method
Psychological Well-being on 6-point Psychological Well-being Scale	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).
Perceived Stress on 5-point Chinese Version of the Perceived Stress Scale	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).
Symptoms of Depression on 4-point Chinese Version of Patient Health Questionnaire-9 (PHQ-9)	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).
Symptoms of Anxiety on 4-point Chinese Version of the Generalized Anxiety Disorder Scale	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).
Cognitive Functioning on the Hong Kong Version of Montreal Cognitive Assessment	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.
Perceived Social Support on 7-point Multidimensional Scale of Perceived Social Support	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."
Social Network on Lubben Social Network Scale at Month 3 and Month 6	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.

Trial Locations

Locations (1)

The Education University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong