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NCT05426837 · ClinicalTrials.gov registry record · NA

Combatting Social Isolation in Older Adults

A NA study, sponsored by Florida State University.

Completed
Registry status
NA
Development phase
70
Enrollment target

NCT05426837: Completed NA study, sponsored by Florida State University.

NCT05426837 is a NA study that has completed, run by Florida State University. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05426837, a NA study, has completed, sponsored by Florida State University.

COMPLETED
Registry status
NA
Development phase
70 participants
Enrollment target

Study 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 report

Primary Outcome

Scores range from 20-80 with higher scores indicating higher levels of loneliness.

Interventions

  • BEHAVIORAL Health Education Training
  • BEHAVIORAL Combatting Social Isolation

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2022-07-30
Est. Completion 2024-07-01
Phase NA
Florida State University

219 total trials

What the finished NCT05426837 record still lists

NCT05426837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Health Education Training is the first listed.

NCT05426837 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05426837 about?

NCT05426837 is a clinical study titled "Combatting Social Isolation in Older Adults". 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 lo...

What is the current status of trial NCT05426837?

This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2022-07-30. Estimated completion is 2024-07-01.

What interventions are being tested in trial NCT05426837?

The interventions under investigation include: Health Education Training (BEHAVIORAL), Combatting Social Isolation (BEHAVIORAL).

Who is sponsoring clinical trial NCT05426837?

This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05426837's enrollment target sits among peer trials

70 1103rd of 2000 higher than 868 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05426837, the US trial registry maintained by the National Library of Medicine. NCT05426837 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.