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NCT05516108 · ClinicalTrials.gov registry record · Phase 1
Remote Mindfulness Training Following Early Life Adversity
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT05516108: Completed Phase 1 study, sponsored by University of Pittsburgh.
NCT05516108 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05516108, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
This study will test the feasibility of delivering smartphone-based mindfulness and coping interventions to a sample of emerging/young adults with a history of early life adversity (ELA). 80 participants with a history of ELA will be randomly assigned to complete a two-week mindfulness training intervention or matched coping control intervention, both involving 14 foundational audio-guided lessons and practice prompts randomly delivered 3x daily. At baseline, post-intervention, and one-month follow-up lab assessments, participants will complete questionnaires and provide blood samples for assessment of markers of inflammation. Data assessing subjective and physiological stress in daily life will be collected during the intervention and for one week before, immediately after, and one month after the intervention. Passive sensor data will be continuously collected from participants' smartphones and wearable devices to develop exploratory models that estimate and predict daily life stress. Data will be used to evaluate feasibility and acceptability of interventions and assessments in an ELA sample, test effects of mindfulness training on daily life stress and markers of inflammation in an ELA sample, and develop exploratory machine learning models of stress from passive sensor data.
Primary Outcome
Recruitment benchmark: \>10% of people screened will be eligible
Interventions
- BEHAVIORAL Mindfulness
- BEHAVIORAL Coping
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2024-05-22 |
| Phase | Phase 1 |
What the finished NCT05516108 record still lists
NCT05516108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 2 interventions - of which Mindfulness is the first listed.
NCT05516108 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05516108 about?
NCT05516108 is a clinical study titled "Remote Mindfulness Training Following Early Life Adversity". This study will test the feasibility of delivering smartphone-based mindfulness and coping interventions to a sample of emerging/young adults with a history of early life adversity (ELA). 80 participants with a history of ELA will be randomly assigned to complete a two-week mindfulness training inte...
What is the current status of trial NCT05516108?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2022-09-01. Estimated completion is 2024-05-22.
What interventions are being tested in trial NCT05516108?
The interventions under investigation include: Mindfulness (BEHAVIORAL), Coping (BEHAVIORAL).
Who is sponsoring clinical trial NCT05516108?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05516108's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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