Clinical trial NCT06423053: Mindfulness in a College Physiology Course
Official title: A Randomized Controlled Trial of a College Human Physiology Course With Integrated Mindfulness Practice on Student Applied Mindfulness and Stress Regulation (2025)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mindfulness
Stress
Perceived Stress
College Student Mental Health
Keywords: Mindfulness
College student
Stress
Applied mindfulness
Lead sponsor: Trustees of Dartmouth College
Sponsor class: OTHER
Collaborators: name: Dartmouth College
First posted: 2024-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group will consist of students enrolled in the Mindful Physiology course (Biology 3) at Dartmouth College in the spring 2025 term (3/31/2025- 6/4/2025). The control group will enroll students waitlisted for the course during the Spring 2025 term. The control participants will receive university wellness resources as usual. These include access to counseling and psychotherapy services at the university's counseling center, wellness advising at the student wellness center, and campus-wide wellness programs, such as weekly group yoga and meditation sessions and a free subscription to the Headspace app.
Primary purpose: PREVENTION

Brief summary: This proposed study aims to evaluate whether integrating mindfulness into an undergraduate biology course (Mindful Physiology) influences student applied mindfulness and stress regulation.

The primary questions are

1. Would completing the Mindful Physiology course increase applied mindfulness?
2. Would completing the course increase self-efficacy in stress regulation?
3. Would completing the course reduce perceived reactivity to acute stressors?

Detailed description: The proposed study aims to evaluate whether integrating mindfulness practice into an undergraduate biology course influences student levels of applied mindfulness and stress regulation self-efficacy. A two-arm design will look at students who receive the intervention (a 10-week biology course with integrated mindfulness practice) 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 who provide informed consent will be enrolled. Data on applied mindfulness and stress regulation self-efficacy will be collected at baseline and the conclusion of the intervention (\~10 weeks). Additionally, over weeks 8 and 9, participants will be invited for an in-person lab visit for a Trier Social Stress Test (TSST-OL) to assess reactivity to an acute social stressor.

This study aims to examine whether integrating mindfulness practice into a ten-week undergraduate-level biology course will enhance applied mindfulness and stress regulation capacity. We hypothesize that completing this ten-week course will (1) increase applied mindfulness, (2) increase self-efficacy in stress regulation, and (3) decrease perceived stress in response to an acute stressor.

Secondary analyses will also evaluate differential changes in individual well-being score components (including learning-related anxiety, self-compassion, social connectedness, alcohol use, media addiction, overall well-being, and physiological reactivity to an acute stressor).

Linear mixed effect models with a time and treatment interaction term and random intercepts by the participant will be fit to examine the first two hypotheses to account for repeated measurements and potential data missingness. To test the third hypothesis, we will compute the pre- to post-stress induction changes in subjective stress. Next, two-sample t-tests will be run on each change score to examine differences in responses to the stress challenge between the two groups. As sensitivity analyses, effect modification by baseline dispositional mindfulness, perceived stress over the last month, and severity of anxiety will be examined by including a three-way interaction term in the models to understand whether the intervention effect differs by these baseline characteristics. Further, the effect of the class on secondary outcomes will be explored with linear mixed-effect models. All analyses will consider a p-value \< 0.05 as statistical significance.

Eligibility criteria: Inclusion criteria: 1. Undergraduate students who selected Biology 3: Mindful Physiology during the 2025 Spring term course enrollment period.

Primary outcomes:
measure: Applied Mindfulness
timeFrame: Baseline and intervention completion (~10 weeks)
measure: Stress Management Self-Efficacy
timeFrame: Baseline and intervention completion (~10 weeks)
measure: Perceived Stress in Response to an Acute Stressor
timeFrame: Intervention completion (~8 and 9 weeks)
Secondary outcomes:
measure: Self-Compassion
timeFrame: Baseline and intervention completion (~10 weeks)
measure: Overall Well-Being
timeFrame: Baseline and intervention completion (~10 weeks)
measure: Social Connectedness
timeFrame: Baseline and intervention completion (~10 weeks)
measure: Mental Well-Being
timeFrame: Baseline and intervention completion (~10 weeks)
measure: Resillience
timeFrame: Baseline and intervention completion (~10 weeks)
measure: Learning-Related Anxiety
timeFrame: Baseline and intervention completion (~10 weeks)
measure: Social Media Addiction
timeFrame: Baseline and intervention completion (~10 weeks)
measure: Alcohol Intake
timeFrame: Baseline and intervention completion (~10 weeks)
measure: Physiological Stress in Response to an Acute Stressor
timeFrame: Intervention completion (~8 and 9 weeks)
Other outcomes:
measure: Dispositional Mindfulness
timeFrame: Baseline and intervention completion (~10 weeks)
measure: Perceived Stress During the Last Month
timeFrame: Baseline and intervention completion (~10 weeks)
measure: Anxiety
timeFrame: Baseline and intervention completion (~10 weeks)
Locations:
city: Hanover
country: United States
facility: Dartmouth College
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Diane Gilbert-Diamond, ScD
role: PRINCIPAL_INVESTIGATOR
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