跳至主要内容
临床试验/NCT07021872
NCT07021872招募中不适用

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

Education University of Hong Kong1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2025年6月30日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
276
试验地点
1
主要终点
Loneliness measured by the UCLA Loneliness Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

Loneliness measured by the UCLA Loneliness Scale

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)
  • Perceived Social Support on 7-point Multidimensional Scale of Perceived Social Support(Baseline, 3-month, and 6-month)
  • Social Network on Lubben Social Network Scale at Month 3 and Month 6(Baseline, 3-month, and 6-month)

研究者

发起方
Education University of Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiang Da

Associate Professor

Education University of Hong Kong

研究点 (1)

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