Mindful Physiology: A College Biology Course With Integrated Mindfulness

Mindfulness Clinical Trial

Official title:

A Randomized Trial of a College Biology Course With Integrated Mindfulness Practice on Student Mindfulness, Learning-Related Anxiety, and Well-Being

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06423053
• Other study ID #: STUDY00032944
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 21, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2024
• Source: Trustees of Dartmouth College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current Dartmouth student who selected Biology 3: Mindful Physiology during 2024 Spring term course enrollment period.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Mindfulness
• Stress Psychological
• Stress, Physiological

Intervention

Behavioral:
• Biology Course with Integrated Mindfulness
This intervention is a college biology course with embedded mindfulness practice. There are 17 class sessions, each 1 hr and 50 min. long, over 9.5 weeks. Students will be taught human physiology through didactic lectures, laboratory activities, and written tests typical for a college course. Each class meeting will have ~20 min. of mindfulness practice in Thich Nhat Hanh's Plum Village tradition. Students are recommended to practice mindfulness for 15 minutes daily. Students are assigned a daily log of their mindfulness practice, and they are given full credit for each log completion regardless of the minutes of mindfulness practices. Students are assigned a weekly written reflection to reflect on the physiology course content and/or their mindfulness practice. All students in the class are required to attend a 4-hr mindfulness retreat Students in the intervention arm will also receive university wellness resources as usual as described for the control arm below.

Locations

Country	Name	City	State
United States	Media and Health Behaviors Lab at Dartmouth	Hanover	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Trustees of Dartmouth College

Country where clinical trial is conducted

United States, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trait Mindfulness	Trait mindfulness will be measured via the Five Facet Mindfulness Questionnaire (FFMQ; total possible score range: 1-5; higher scores indicate higher trait mindfulness).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Primary	Applied Mindfulness	Application of mindfulness in everyday life will be measured via the Applied Mindfulness Process Scale (AMPS; total possible score range: 0-60; higher scores indicate more application of mindfulness practice in daily life).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Primary	Composite Well-Being Score	This composite score is the average z-score of 8 physical and emotional health metrics (Loucks et al., 2021). They are (1) sleep (5-day accelerometry and/or Pittsburg Sleep Quality Index; score range: 0-21; higher scores = poorer sleep quality), (2) physical activity (International Physical Activity Questionnaire and/or 5-day accelerometry), (3) diet (short Health Eating Index; range: 0-100; higher scores = higher diet quality) and (4) alcohol intake (Quick Drinking Screen), (5) media use (Bergen Social Media Addiction Scale; range: 6-30; higher scores = more problematic media use), (6) mental stress (Perceived Stress Scale-10; range: 0-40; higher scores = more perceived stress), (7) mental well-being (Warwick-Edinburgh Mental Well-being Scale; range: 14-70; higher scores = more mental well-being), and (8) loneliness (UCLA-Loneliness Scale; range: 0-60; higher scores = more perceived loneliness).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Primary	Learning-Related Anxiety	Learning-related anxiety subscale from the Achievement Emotion Questionnaire-short version (AEQ-S; total possible score range: 1-5; higher scores indicate greater learning-related anxiety).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary	Self-Compassion	Measured via Self-Compassion Scale (; total possible score range: 1-5; higher scores indicate higher levels of self-compassion).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary	Mindful Eating	Measured via Mindful Eating Questionnaire (MEQ; total possible score range: 1-4; higher scores indicate more mindful eating).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary	Trait Gratitude	Measured via Gratitude Questionnaire (GQ-6; total possible score range: 1-7; higher scores indicate higher levels of trait gratitude).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary	Self-Report Sleep	Measured via the Pittsburg Sleep Quality Index (PSQI, total possible score range: 0-21; higher scores indicate poorer sleep quality).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary	Self-Report Physical Activity	Measured via the International Physical Activity Questionnaire (total multiples of the resting metabolic rate (MET) minutes per week in the past week).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary	Diet Quality	Measured via the short Health Eating Index (sHEI, possible total score range: 0-100; higher scores indicate higher diet quality).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary	Alcohol Intake	Measured via the Quick Drinking Screen (i.e., the number of standard drinks per week). One standard drink is one 12-oz. regular can or glass of beer, one 5-oz. glass of regular wine, or one 1/2-oz. of regular-proof hard liquor or spirits.	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary	Media Use	Measured via the Bergen Social Media Addiction Scale (BSMAS, total possible score ranges from 6-30; higher scores indicate more problematic media use).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary	Perceived Stress	Measured via the Perceived Stress Scale, 10-item version (PSS-10; total possible score range: 0-40; higher scores indicate more perceived stress).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary	Subjective Well-being	Measured via the Warwick-Edinburgh Mental Well-being Scale (WEMWBS, total possible score range: 14-70; higher scores show greater mental well-being).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary	Social Connectedness	Measured via the UCLA-Loneliness Scale (total score range: 0-60; higher scores show more perceived loneliness).	Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary	Physiologic Stress (HRV)	Measured via a polar chest strap for 24 hours.	Baseline and intervention completion(~10 weeks)
Secondary	Physiologic Stress (Cortisol)	Measured via hair cortisol concentration.	Baseline and intervention completion (~10 weeks)
Secondary	Actigraphy-Assessed Sleep	Measured via a wrist-worn accelerometer for 5 days.	Baseline and intervention completion (~10 weeks)
Secondary	Actigraphy-Assessed Physical Activity	Measured via a wrist-worn accelerometer for 5 days.	Baseline and intervention completion (~10 weeks)