Combating Social Isolation in Older Adults: A Cluster Randomized Controlled Trial in China

Last registered on April 03, 2025

Pre-Trial

Trial Information

General Information

Title
Combating Social Isolation in Older Adults: A Cluster Randomized Controlled Trial in China
RCT ID
AEARCTR-0015671
Initial registration date
March 28, 2025

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
April 03, 2025, 12:35 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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Primary Investigator

Affiliation
Wuhan University

Other Primary Investigator(s)

Additional Trial Information

Status
On going
Start date
2025-02-01
End date
2026-03-01
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Social isolation and loneliness among older adults represent significant public health challenges in aging societies. This cluster randomized controlled trial investigates the effectiveness of two interventional strategies in mitigating depression and enhancing social well-being among individuals aged 60 and above in urban and rural communities. The study will enroll more than 2000 participants across 20 counties, randomly assigned to three groups: a control group without intervention, a social interaction group participating in group activities and community outings, and a comprehensive intervention group receiving social interactions plus individual cognitive behavioral therapy sessions. Over a six-month intervention period, primary and secondary outcomes will comprehensively assess participants' health and well-being, including depression levels (GDS-15), loneliness (UCLA Loneliness Scale), quality of life (SF-12), self-reported health status, physical functioning (Short Physical Performance Battery), cognitive function (Mini-Mental State Examination), and social support (Lubben Social Network Scale). Participants will undergo assessments at baseline, 3 months, 6 months, and a 12-month follow-up. By comparing these intervention approaches, the research seeks to generate evidence-based insights into effective strategies for improving mental health, social engagement, and overall well-being among older adults, potentially informing future community-based intervention programs and social support policies.
External Link(s)

Registration Citation

Citation
Chan, Matthew. 2025. "Combating Social Isolation in Older Adults: A Cluster Randomized Controlled Trial in China." AEA RCT Registry. April 03. https://doi.org/10.1257/rct.15671-1.0
Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2025-03-01
Intervention End Date
2025-09-01

Primary Outcomes

Primary Outcomes (end points)
Depression Severity, Loneliness Level, Quality of Life, Physical Functioning, etc.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
This cluster randomized controlled trial aims to investigate the effectiveness of social interventions on mental health and well-being among older adults. The study will be conducted across 20 counties, involving 2,040 participants aged 60 and above, randomly allocated into three distinct intervention groups. Participants will be recruited from urban and rural communities, ensuring a diverse and representative sample. The experimental design employs a three-arm approach: a control group maintaining standard daily activities, a social interaction group engaged in structured group activities and community outings, and a comprehensive intervention group receiving both social interactions and individual cognitive behavioral therapy. The intervention period spans six months, with participants undergoing comprehensive assessments at baseline, 3 months, 6 months, and a 12-month follow-up. Each community will be treated as a cluster to minimize potential contamination between intervention groups. Randomization will be performed using a computer-generated sequence to ensure unbiased group allocation. The study will utilize validated measurement tools to assess depression, loneliness, quality of life, and physical functioning, providing a holistic evaluation of intervention impacts. Ethical considerations are paramount, with voluntary participation, informed consent, and the option to withdraw at any time without consequences. By comparing these intervention strategies, the research seeks to generate evidence-based insights into effective approaches for enhancing older adults' mental health and social engagement.
Experimental Design Details
Not available
Randomization Method
randomization done in office by a computer
Randomization Unit
community
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
120 communities
Sample size: planned number of observations
2040 individuals
Sample size (or number of clusters) by treatment arms
60 communities control, 30 communities only interaction, 30 communities both interaction and therapy
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
Wuhan University
IRB Approval Date
2025-02-01
IRB Approval Number
N/A