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Идёт набор NCT07543653

Evaluating the Effectiveness of Interventions to Reduce Loneliness in Chinese Young Adults

Без фазы С лечением Loneliness

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Group-based Positive Affect Intervention, Group-based Social Skills Training.
Кому может быть актуально
Состояния в реестре: Loneliness. Базовые параметры: 18 лет — 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Гонконг
Следующий шаг
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Официальное название

Group-Based Positive Affect Intervention for Loneliness Reduction: A Randomized Controlled Trial in Chinese Young Adults

Обзор

This study aims to evaluate the effectiveness of a group-based Positive Affect (PA) intervention compared to an active control condition, Social Skills Training (SST), in reducing loneliness among young adults in Hong Kong and mainland China. It further examines the psychological mechanisms underlying intervention effects, specifically the roles of positive affect and perceived social support as mediators, and rejection sensitivity as a moderator influencing both treatment responsiveness and outcome translation.

Подробное описание

Loneliness among young adults has become a growing public health concern, linked to depression, anxiety, low self-esteem, and reduced life satisfaction. Unlike older adults, whose loneliness is often tied to social isolation, loneliness in young adulthood is shaped by developmental transitions, shifting relational needs, and heightened sensitivity to social evaluation. Existing interventions largely target older populations and often fail to address the emotional and cognitive processes central to loneliness in younger groups.

This study addresses these gaps by adopting a multi-theoretical framework that integrates the Social Needs Perspective, Weiss's Multidimensional Theory, the Cognitive Discrepancy Model, and the Reaffiliation Motive Model. Together, these perspectives conceptualize loneliness as arising from unmet needs for meaningful connection, discrepancies between desired and actual relationships, and maladaptive cognitive and behavioral responses that hinder reconnection.

The study employs a two-arm randomized controlled trial design. A total of 100 college students in Hong Kong and mainland China who report elevated loneliness will be recruited and screened using the UCLA Loneliness Scale. Eligible participants will be randomly assigned to either the group-based Positive Affect (PA) intervention or the group-based Social Skills Training (SST) active control condition. Both interventions will be delivered in four weekly group sessions lasting 45-60 minutes.

* The PA Intervention: Grounded in the Broaden-and-Build Theory and revised Stress and Coping Theory. It adopts a multi-skill approach to enhance positive emotions through practices such as savoring positive events, gratitude, mindfulness, positive reappraisal, strengths identification, goal setting, and acts of kindness. These skills are expected to increase positive affect, promote social engagement, and strengthen psychological resources, thereby reducing loneliness. * The SST Intervention: Serves as an active control and focuses on improving interpersonal competence. It includes training in social behavior styles (assertive, shy, and aggressive), initiating and maintaining social interactions, setting boundaries, giving and receiving feedback, and conflict resolution. Improvements in interpersonal competence are expected to enhance perceived social support, which in turn reduces loneliness.

Primary outcomes will be assessed using the UCLA Loneliness Scale, with additional measures capturing positive affect, perceived social support, social network discrepancy, mindfulness, emotion regulation, self-efficacy, and rejection sensitivity. Data will be collected at baseline, with follow-ups at 1 and 3 months. Linear mixed-effects models will be used to examine intervention effects over time, while mediation and moderated mediation analyses will test the proposed mechanisms.

A key innovation of this study lies in its examination of mechanisms. Positive affect and perceived social support are hypothesized as mediators, reflecting emotional and relational pathways to loneliness reduction. Rejection sensitivity is modeled as a moderator that influences both how participants respond to the intervention and how gains translate into reduced loneliness. Individuals with high rejection sensitivity may show weaker intervention effects due to heightened threat perception and social withdrawal tendencies.

This research contributes to both theory and practice by testing a developmentally appropriate, mechanism-driven intervention for young adults. It advances understanding of how emotional and social processes interact in loneliness reduction and provides evidence for scalable, group-based interventions that can be implemented in university and community settings.

Вмешательства

  • Поведенческое Group-based Positive Affect Intervention
    This 4-week intervention consists of eight skills aimed at enhancing positive affect, delivered via group-based psychoeducation by trained facilitators. Participants will learn skills such as gratitude, mindfulness, and positive reappraisal, with sessions held once a week to test the effects of the intervention in reducing loneliness among young adults.
  • Поведенческое Group-based Social Skills Training
    The SST intervention serves as an active control and focuses on improving interpersonal competence. It includes training in social behavior styles (assertive, shy, and aggressive), initiating and maintaining social interactions, setting boundaries, giving and receiving feedback, and conflict resolution. Improvements in interpersonal competence are expected to enhance perceived social support, which in turn reduces loneliness. The intervention will be delivered over a 4-week period.

Первичные конечные точки

  • Loneliness measured by the University of California, Los Angeles (UCLA) Loneliness Scale [Срок оценки: Baseline, 1-month, and 3-month]
Вторичные конечные точки (4)
  • Perceived Stress on the Perceived Stress Scale (PSS-10) [Срок оценки: Baseline, 1-month, and 3-month]
  • Symptoms of Depression on the Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline, 1-month, and 3-month]
  • Symptoms of Anxiety on the Generalized Anxiety Disorder-7 (GAD-7) Scale [Срок оценки: Baseline, 1-month, and 3-month]
  • Perceived Social Support on the Multidimensional Scale of Perceived Social Support (MSPSS) [Срок оценки: Baseline, 1-month, and 3-month]

Критерии участия

Критерии включения

  • aged 18 to 30 years
  • proficiency in Chinese (Cantonese or Mandarin)
  • experiencing loneliness (defined as a score of ≥ 6 on the 3-item UCLA Loneliness Scale)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • The Education University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT07543653 · 2024-2025-0467

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗