Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423053
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-03-21
Brief Title:
Mindful Physiology A College Biology Course With Integrated Mindfulness
Sponsor:
Trustees of Dartmouth College
Organization:
Trustees of Dartmouth College
Study Overview
Official Title:
A Randomized Trial of a College Biology Course With Integrated Mindfulness Practice on Student Mindfulness Learning-Related Anxiety and Well-Being
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study aims to evaluate whether integrating mindfulness practice into an undergraduate biology course influences student levels of mindfulness stress positive academic emotions and physical mental and social health outcomes These outcomes will be evaluated for students who enroll in the biology course compared to students who attempted to register but were put on a waitlist waitlisted
Detailed Description:
The proposed study aims to evaluate whether integrating mindfulness practice into an undergraduate biology course influences student levels of mindfulness learning-related anxiety and well-being A two-arm design will look at students who receive the intervention academic course plus usual care and a control group of waitlisted students for the course who will only receive university wellness resources Participants all attempted to register for the course during a set course selection period at the college and were randomly registered or waitlisted by the College Registrar Students registered and waitlisted for the course will be recruited for the study and those that provide informed consent will be enrolled Data relating to mindfulness learning-related anxiety and well-being will be collected at baseline mid-intervention 5 weeks at the conclusion of the intervention 10 weeks and at 20 weeks The primary analyses will evaluate whether there is a greater 1 increase in mindfulness 2 increase in composite well-being score and 3 decrease in learning-related anxiety in the intervention arm compared to the control arm The secondary analyses will evaluate whether there is a greater 1 increase in heart rate variability and 2 reduction in hair cortisol in the intervention arm compared to the control arm Secondary analyses will also evaluate differential changes in individual well-being score components including physical activity sleep diet alcohol use media use perceived stress overall mental well-being and loneliness The analytical approach will examine if changes in outcomes are greater in the intervention group than in the usual care group via linear mixed-effect or linear regression models as appropriate adjusting for covariates Statistical analyses will follow an intention-to-treat approach and include all participants regardless of intervention completion A p-value of 05 will be used as the threshold for statistical significance for all tests In addition any outcomes with observed statically significant differences between the arms will be re-collected and analyzed for differences at 10 weeks post-intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None