Mindfulness Intervention for Concussion, Brain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of North Carolina at Chapel Hill, Chapel Hill, NC
Concussion, Brain+3 More
Mindfulness Exercises and Meditations - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Concussion, Brain
  • Post Concussion Syndrome

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Approximately 7 to 42 days after intervention initiation.

Day 42
Mean Days of Mindfulness Exercises/Meditations Completed Per Week
Week 6
Mean Acceptability of Intervention (AIM) Total Score
Mean Feasibility of Intervention (FIM) Total Score
Week 6
Mean Five Facet Mindfulness Questionnaire (FFMQ) Total Score
Mean Perceived Stress Scale (PSS-10) Total Score
Mean Rivermead Post-Concussion Questionnaire (RPQ) Symptom and Severity Score

Trial Safety

Trial Design

1 Treatment Group

Mindfulness Intervention
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Mindfulness Intervention · No Placebo Group · N/A

Mindfulness Intervention
Behavioral
Experimental Group · 1 Intervention: Mindfulness Exercises and Meditations · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 7 to 42 days after intervention initiation.
Closest Location: The University of North Carolina at Chapel Hill · Chapel Hill, NC
2012First Recorded Clinical Trial
1 TrialsResearching Concussion, Brain
61 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.