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NCT04560088 · ClinicalTrials.gov registry record · NA
Mindfulness to Reduce Loneliness in Older Caregivers
A NA study, sponsored by University of Rochester.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
NCT04560088: Completed NA study, sponsored by University of Rochester.
NCT04560088 is a NA study that has completed, run by University of Rochester. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04560088, a NA study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
Study Summary
The objective of this pilot study is to provide initial evidence of the role of mindfulness training in improving social disconnectedness - including social isolation and feelings of loneliness - in older caregivers for family members with ADRD. The investigators propose a two-arm randomized control trial: participants will be randomized to (a) smartphone-based MBSR app (Headspace) or (b) active control (breathing app) for 14 days. Loneliness and quality of social interactions will be assessed using Ecological Momentary Assessment at baseline and 14-days after randomization.
Primary Outcome
The FFMQ assesses five factors that represent mindfulness as it is currently conceptualized: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience, and a total score indicating overall mindfulness. The 39 items of the FFMQ are rated on a 5-point Likert scale, ranging from 1 (never or very rarely true) to 5 (very often or always true). The total score ranges from 39-195, with higher scores indicating greater mindfulness. Data present
Interventions
- BEHAVIORAL Mindfulness
- BEHAVIORAL Breathing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-01-05 |
| Est. Completion | 2022-07-21 |
| Phase | NA |
What the finished NCT04560088 record still lists
NCT04560088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Mindfulness is the first listed.
NCT04560088 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04560088 about?
NCT04560088 is a clinical study titled "Mindfulness to Reduce Loneliness in Older Caregivers". The objective of this pilot study is to provide initial evidence of the role of mindfulness training in improving social disconnectedness - including social isolation and feelings of loneliness - in older caregivers for family members with ADRD. The investigators propose a two-arm randomized control...
What is the current status of trial NCT04560088?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2021-01-05. Estimated completion is 2022-07-21.
What interventions are being tested in trial NCT04560088?
The interventions under investigation include: Mindfulness (BEHAVIORAL), Breathing (BEHAVIORAL).
Who is sponsoring clinical trial NCT04560088?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04560088's enrollment target sits among peer trials
55 1264th of 2000 higher than 733 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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