- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07543653
Evaluating the Effectiveness of Interventions to Reduce Loneliness in Chinese Young Adults
Group-Based Positive Affect Intervention for Loneliness Reduction: A Randomized Controlled Trial in Chinese Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: JIN ZHANG
- Phone Number: 85229487138
- Email: s1151958@s.eduhk.hk
Study Locations
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong
- Recruiting
- The Education University of Hong Kong
-
Contact:
- JIN ZHANG
- Phone Number: 85229487138
- Email: s1151958@s.eduhk.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group-based Social Skills Training
Participants in the Social Skills Training (SST) group will receive a group-based SST intervention as an active control.
|
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.
|
|
Experimental: Group-based Positive Affect Intervention
Participants in the Positive Affect (PA) group will receive a group-based psychoeducation intervention designed to test its effectiveness in reducing loneliness among college students.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loneliness measured by the University of California, Los Angeles (UCLA) Loneliness Scale
Time Frame: Baseline, 1-month, and 3-month
|
The UCLA Loneliness Scale is a reliable self-assessment tool designed to evaluate subjective feelings of loneliness. Total scores are calculated based on individual item ratings ranging from 1 (never) to 4 (always). Higher scores indicate a greater degree of loneliness (worse outcome). |
Baseline, 1-month, and 3-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress on the Perceived Stress Scale (PSS-10)
Time Frame: Baseline, 1-month, and 3-month
|
The Chinese version of the Perceived Stress Scale is a validated self-report tool used to measure the degree to which situations in one's life are appraised as stressful. Individual items are rated on a scale from 0 (never) to 4 (very often). Higher scores indicate higher levels of perceived stress (worse outcome). |
Baseline, 1-month, and 3-month
|
|
Symptoms of Depression on the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, 1-month, and 3-month
|
The Patient Health Questionnaire-9 is a reliable self-report measure designed to evaluate the severity of depressive symptoms over the past two weeks. Possible scores for each item range from 0 (not at all) to 3 (nearly every day). Higher scores indicate more severe symptoms of depression (worse outcome). |
Baseline, 1-month, and 3-month
|
|
Symptoms of Anxiety on the Generalized Anxiety Disorder-7 (GAD-7) Scale
Time Frame: Baseline, 1-month, and 3-month
|
The Chinese version of the Generalized Anxiety Disorder-7 Scale is a validated, self-reported instrument assessing the severity of anxiety symptoms. Possible scores for each item range from 0 (not feeling at all) to 3 (most of the time).Higher scores indicate more severe symptoms of anxiety (worse outcome). |
Baseline, 1-month, and 3-month
|
|
Perceived Social Support on the Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: Baseline, 1-month, and 3-month
|
The Multidimensional Scale of Perceived Social Support evaluates the social support derived from three key sources: family, friends, and significant others. Respondents rate each item on a 7-point Likert scale, where 1 represents "very strongly disagree" and 7 indicates "very strongly agree." Higher scores indicate a higher level of perceived social support (better outcome). |
Baseline, 1-month, and 3-month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Affective Experience over the Past Week on the 30-item Affect Valuation Index (AVI)
Time Frame: Baseline, 1-month, and 3-month
|
The Affect Valuation Index (AVI) is a validated, self-reported instrument assessing affective experiences over the past week. It evaluates the frequency of actual emotions experienced. Possible scores for each emotion item range from 1 (very slightly or not at all) to 5 (extremely or all the time). Higher scores indicate a greater frequency of that specific affective state. (Note: High scores in positive affect represent a better outcome, while high scores in negative affect represent a worse outcome). |
Baseline, 1-month, and 3-month
|
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Meaning of Life on 7-point Meaning in Life Questionnaire (MLQ)
Time Frame: Baseline, 1-month, and 3-month
|
The Meaning in Life Questionnaire (MLQ) is a reliable self-assessment tool that evaluates an individual's sense of meaning in life across two subscales: Presence of Meaning and Search for Meaning. Each subscale (5 items each) has a minimum score of 5 and a maximum score of 35. Higher scores on the Presence subscale indicate a stronger sense that life is meaningful. Higher scores on the Search subscale indicate a greater drive to find meaning. |
Baseline, 1-month, and 3-month
|
|
Gratitude on 7-point Gratitude Scale Questionnaire-Six Item Form (GQ-6)
Time Frame: Baseline, 1-month, and 3-month
|
The Gratitude Questionnaire-Six Item Form (GQ-6) is a validated self-report measure that evaluates the inclination to recognize and respond to life events with gratitude. Total scores range from 6 (strongly disagree across all items) to 42 (strongly agree across all items). Higher scores indicate a higher level of dispositional gratitude (better outcome). |
Baseline, 1-month, and 3-month
|
|
Mindfulness on the 5-point Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline, 1-month, and 3-month
|
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated measure assessing five different elements of mindfulness in daily life. Responses are scored on a scale from 1 (never or very rarely true) to 5 (very often or always true). Higher scores indicate higher levels of mindfulness (better outcome). |
Baseline, 1-month, and 3-month
|
|
Cognitive Reappraisal on the 7-point Emotion Regulation Questionnaire (ERQ)
Time Frame: Baseline, 1-month, and 3-month
|
The Emotion Regulation Questionnaire (ERQ) is a validated instrument assessing strategies used to manage emotions, specifically Cognitive Reappraisal and Expressive Suppression. Items are rated from 1 (strongly disagree) to 7 (strongly agree). The Reappraisal subscale (6 items) ranges from 6 to 42. Higher scores on Cognitive Reappraisal indicate more frequent use of adaptive emotional regulation (better outcome). |
Baseline, 1-month, and 3-month
|
|
Self-Efficacy on the 4-point General Self-Efficacy Scale (GSE)
Time Frame: Baseline, 1-month, and 3-month
|
The General Self-Efficacy Scale (GSE) measures an individual's optimistic beliefs regarding their capacity to manage challenging situations and cope with stressors. This 10-item scale ranges from a total minimum of 10 to a maximum of 40 (based on a 1-4 Likert scale). Higher scores indicate a stronger belief in one's own self-efficacy (better outcome). |
Baseline, 1-month, and 3-month
|
|
Interpersonal Competence on the 15-item Interpersonal Competence Questionnaire (ICQ-15)
Time Frame: Baseline, 1-month, and 3-month
|
The 15-item Interpersonal Competence Questionnaire (ICQ-15) assesses self-reported proficiency across five social domains, including initiating relationships and conflict management. It is using a 4-point Likert-type scale, where 1 indicates "I'm always poor at this" and 4 represents "I'm always good at this." Total scores range from 15 to 60. Higher scores indicate a higher level of interpersonal proficiency and social skill (better outcome). |
Baseline, 1-month, and 3-month
|
|
Rejection Sensitivity on the Adult Rejection Sensitivity Questionnaire (A-RSQ)
Time Frame: Baseline, 1-month, and 3-month
|
The Adult Rejection Sensitivity Questionnaire (A-RSQ) assesses cognitive-affective processing styles regarding the expectation of social rejection. Scores are calculated based on concern and likelihood of rejection across 15 items, with total scores typically ranging from 1 to 36 (mean score). Higher scores indicate a greater sensitivity to and anxious expectation of social rejection (worse outcome). |
Baseline, 1-month, and 3-month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024-2025-0467
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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