CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Combatting Social Isolation +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05426837
NCT05426837N/ACompleted

Combating Social Isolation in Older Adults: Randomized Clinical Trial Evaluating the Acceptability and Efficacy of a Brief, Technology Delivered Intervention

Florida State University·interventional·Posted Jun 22, 2022·Updated Feb 26, 2025

In Brief

A clinical study evaluating Combatting Social Isolation and Health Education Training for Loneliness and Social Isolation. Completed, enrolled 70 participants across 1 site.

Detailed Summary

Increasing evidence suggests that perceived social isolation and loneliness are major risk factors for physical and mental illness in later life. The prevalence of loneliness in US older adults warrants concern, with an estimated 30% of American adults aged 70 years and older reporting heightened loneliness. A wide variety of interventions have been developed to address social isolation and loneliness ranging from social facilitation to animal therapies. While many intervention studies have attempted to address loneliness, social isolation and related constructs in older adults, this literature is underdeveloped and there is not an established or widely accepted set of treatments. Moreover, existing treatments tend to be lengthy, burdensome, and result in high dropout rates. Brief, mechanism focused interventions are an alternative to more traditional forms of treatment. Because they are structured and brief, these treatments can be readily placed on the internet, making them extremely efficient, destigmatizing, and highly scalable. The investigators have developed and tested a web-based intervention called "Combating Social Isolation" (CSI) that the investigators believe offers an alternative to existing interventions for loneliness and social isolation in older adults. CSI evolved out of Interpersonal Theories of mood psychopathology (Joiner, 2005) and targets two risk factors central to social disconnection: perceived burdensomeness and thwarted belongingness (PB/TB). The investigators have one randomized clinical trial using CSI and are nearing completion of two other RCTs using this intervention. Evidence shows that CSI has very high levels of acceptability, and despite the brevity of the protocol (approximately 1 hour) can markedly impact loneliness. Moreover, reductions in these risk factors mediate later improvements in mental health outcomes and social disruption. The purpose of the current proposal is to adapt our existing protocol for older adults reporting loneliness and then obtain preliminary acceptability and efficacy data from a Phase II randomized clinical trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedJun 22, 2022
Enrollment StartJul 30, 2022
Primary CompletionJul 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.0 years ago

Interventions

Combatting Social Isolationbehavioral

A brief, computerized psychoeducational intervention designed to target ways to cope with and address loneliness and social isolation in older adults modeled after our group's previous Building Stronger Allies (BSA) intervention.

Health Education Trainingbehavioral

Control condition where participants learn about healthy lifestyle behaviors.