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NCT05399849 · ClinicalTrials.gov registry record · NA
Mindfulness Intervention in Young Adults With a Concussion History
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT05399849: Completed NA study, sponsored by University of North Carolina, Chapel Hill.
NCT05399849 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05399849, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
Young adults (aged 18-30) with a concussion history (defined as experiencing a concussion within the past five years but not within the past month) will complete a six-week mindfulness intervention. Throughout the intervention, participants will complete 10-20 minutes of mindfulness-focused exercises and meditations each day using the LoveYourBrain Foundation Meditation Library. Before the intervention, participants will complete a baseline assessment including demographics, concussion history, mental health history, mindfulness history, perceived stress, mindfulness, and concussion symptoms. Throughout the intervention, participants will complete weekly assessments measuring adherence and concussion symptoms. After six weeks, participants will complete a final, follow-up assessment with assessments for adherence, acceptability, feasibility, intervention perceptions, perceived stress, mindfulness, and concussion symptoms. This study's aim is to determine the acceptability, feasibility, usability, and effectiveness of a mindfulness intervention in young adults with a concussion history. The investigators hypothesize that participants who participate in the mindfulness intervention will report high adherence (complete five days of meditation per week), positive acceptability, positive feasibility, and positive intervention perceptions. Additionally, after completing the intervention, participants will report decreased perceived stress, increased mindfulness, and decreased concussion symptoms compared to before the intervention.
Primary Outcome
Acceptability will be assessed during the post-intervention follow-up (week 6) assessment using the AIM. The AIM is a four-item validated measure assessing associations with an intervention. It is assessed on a five-point scale from 1=completely disagree to 5=completely agree. A total score will be computed by summing the responses for all four items (higher scores indicating more positive acceptance). The outcome for acceptability will be the AIM total score (range=4-20). The mean AIM total sco
Interventions
- BEHAVIORAL Mindfulness Exercises and Meditations
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-07-25 |
| Est. Completion | 2022-10-02 |
| Phase | NA |
What the finished NCT05399849 record still lists
NCT05399849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Mindfulness Exercises and Meditations is the first listed.
NCT05399849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05399849 about?
NCT05399849 is a clinical study titled "Mindfulness Intervention in Young Adults With a Concussion History". Young adults (aged 18-30) with a concussion history (defined as experiencing a concussion within the past five years but not within the past month) will complete a six-week mindfulness intervention. Throughout the intervention, participants will complete 10-20 minutes of mindfulness-focused exercise...
What is the current status of trial NCT05399849?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2022-07-25. Estimated completion is 2022-10-02.
What interventions are being tested in trial NCT05399849?
The interventions under investigation include: Mindfulness Exercises and Meditations (BEHAVIORAL).
Who is sponsoring clinical trial NCT05399849?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05399849's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 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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