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NCT Number: NCT06423053

Mindfulness in a College Physiology Course

This proposed study aims to evaluate whether integrating mindfulness into an undergraduate biology course (Mindful Physiology) influences students' trait and applied mindfulness, well-being, and physiological stress reactivity.

The primary questions are

1. Would completing the Mindful Physiology course increase applied mindfulness? 2. Would completing the class increase trait mindfulness? 3. Would completing the class increase subjective well-being? 4. Would completing the class reduce physiological stress response to an acute social stressor?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth College

Hanover, New Hampshire, 03755, United States

About this study

The proposed study aims to evaluate whether integrating mindfulness practice into an undergraduate biology course influences students' levels of applied mindfulness and stress regulation self-efficacy. A two-arm design will compare students who receive the intervention (a 10-week biology course with integrated mindfulness practice) with a control group of waitlisted students for the course, who will receive only 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 trait mindfulness, applied mindfulness, and well-being 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) to assess their physiological response to an acute social stressor.

This study aims to examine whether integrating mindfulness practice into a ten-week undergraduate-level biology course will enhance trait and applied mindfulness, well-being, and stress regulation. We hypothesize that completing this ten-week course will (1) increase applied mindfulness, (2) increase trait mindfulness, (3) increase well-being, and (4) decrease physiological stress response to an acute social stressor.

For the primary outcomes, we will examine the between-group differences in changes in applied mindfulness, trait mindfulness, heart rate response to the TSST, and the WHO-5 Index, using linear regression models with change scores in each outcome as the dependent variable and the group status as the independent variable, adjusted for age and sex. We will report Cohen's d to estimate the effect sizes.

As exploratory analyses, we will examine the dose-response relationship between practice time (assessed with self-report practice time) and changes in primary and other outcomes over the term. Additionally, we will rerun the primary analysis by combining data from Spring 2026 with data from the cohort from the previous cycle (Spring 2025). Further, we will explore any between-group differences in changes in heart rate and heart rate variability during the TSST preparation and speaking task, separately, with linear regression models, adjusted for age and sex. All analyses will consider p-values < 0.05 as statistically significant.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Undergraduate students who selected Biology 3: Mindful Physiology during the 2026 Spring term course enrollment period.

Treatment and study plan

Biology Course with Integrated Mindfulness

Behavioral

The intervention, Mindful Physiology, is an undergraduate-level biology course embedded with mindfulness practices. Over 10 weeks, students attend 19 110-minute sessions that combine didactic lectures, labs, and quizzes with ~20 minutes of mindfulness practice daily, in the tradition of Thích Nhất Hạnh's Plum Village Zen Buddhism. Students complete daily mindfulness logs (credited regardless of duration) and weekly reflections on course content or practice. Students are encouraged to practice for 15 minutes daily outside of class, at least 5 days a week. They are also required to attend a group mindfulness session of 30 mins or longer each week. Students are required to attend either a 4.5-hour on-campus mindfulness retreat or a two-day (16-hour) on-campus mindfulness retreat.

Primary outcomes

  1. Applied Mindfulness

    Time frame: Baseline and intervention completion (~10 weeks)

    Students will complete the Applied Mindfulness Process Scale (AMPS) at baseline and post-intervention completion. The scale consists of 15 questions that quantify the application of mindfulness skills to navigate difficult situations and stressors in life. The AMPS encompasses three subscales: decentering, negative emotion regulation, and positive emotion regulation. The total scores are the sum of the item scores. The total possible scores range from 0 to 60. Higher scores reflect a more active use of mindfulness practice in everyday life. The scale demonstrated high internal consistency (Cronbach's α = 0.91) among 134 adults in the original study.

  2. Trait Mindfulness

    Time frame: Baseline and intervention completion (~10 weeks)

    Trait mindfulness will be assessed with the Five Facet Mindfulness Questionnaire (FFMQ), a 39-item questionnaire evaluating five distinct components of mindfulness: observation (8 items), description (8 items), aware actions (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). The total score is the average across the five subscales. Possible scores range from 1 to 5, with higher scores indicating higher dispositional mindfulness.

  3. Physiological Stress Response to an Acute Stressor

    Time frame: Intervention completion (~8 and 9 weeks)

    At the time of intervention completion, physiological stress reactivity will be evaluated using the online version of the Trier Social Stress Test (TSST) in our laboratory (Heyers et al., 2025). During the TSST, heart rate will be measured using a chest-worn Polar H10 (Polar Electro Oy, Kempele, Finland) (Schaffarczyk et al., 2022) and video-based photoplethysmography (PPG) (Pirzada et al., 2023). Wrist collected PPG heart rate data will also be measured during the TSST-OL (ActiGraph LEAP; Ametris, Pensacola, Florida). Raw inter-beat intervals will be recorded via Bluetooth pairing with an accelerometer (ActiGraph wGT3X-BT; Ametris, Pensacola, Florida). The mean heart rate (MHR) will be computed during the baseline resting phase, the TSST (speech preparation and speaking), and the recovery phase (Nyklíček et al., 2013). Reactivity to the acute stressor will be operationalized as differences in heart rate parameters during the TSST (preparation + speaking) compared to the baseline.

  4. Well-Being

    Time frame: Baseline and intervention completion (~10 weeks)

    Well-being will be assessed with the 5-item World Health Organization Well-Being Index (WHO-5). Participants will rate five positively phrased items on subjective well-being, i.e., "I have felt cheerful and in good spirits." Responses are anchored from 0 (none of the time) to 5 (all the time). The total score is the sum of item responses ranging from 0 to 25, with 25 indicating the maximum possible mental well-being. The index has shown high internal consistency with α = 0.86 and test-retest reliability of r = 0.77 in 903 college students.

Other outcomes

  1. Harmful Alcohol Intake

    Time frame: Baseline and intervention completion (~10 weeks)

    Harmful alcohol intake will be assessed via the Consumption subscale from the Alcohol Use Disorders Identification Test (AUDIT-C). The AUDIT-C has three items on the frequency and quantity of alcohol use. The total score is the sum across items, which range from 0 to 12, with higher scores indicating a higher risk of alcohol abuse or dependence. A score of 3 and above is indicative of possible risky drinking that warns of clinical concerns.

  2. Social Media Addiction

    Time frame: Baseline and intervention completion (~10 weeks)

    Addictive use of social media will be examined with the Bergen Social Media Addiction Scale (BSMAS). Participants will rate six items reflecting elements of addiction to social media, e.g., "I spent a lot of time thinking about social media or planned use of social media (salience)" and "I felt an urge to use social media more and more (craving/tolerance)." Responses are anchored from 1 (very rarely) to 5 (very often). A total score will be computed by summing all item responses (range: 1 to 30). Higher scores indicate more addictive use of social media. The scale has shown adequate internal validity (α = 0.88, N = 23533 adults).

  3. Social Connectedness

    Time frame: Baseline and intervention completion (~10 weeks)

    Social belongingness will be measured via the revised Social Connectedness Scale (SCS-r). Participants will rate 20 items on a six-point Likert scale from 1 (strongly disagree) to 6 (strongly agree), e.g., "I am able to relate to my peers." A total score will be computed by taking the sum across items. Possible scores range from 20 to 120, with 120 indicating the strongest sense of belongingness.

  4. Learning-Related Anxiety

    Time frame: Baseline and intervention completion (~10 weeks)

    Anxiety around learning will be assessed with the learning-related anxiety subscale from the Achievement Emotions Questionnaire-Short Form (AEQ-S). Participants will rate four five-point Likert scales on feelings of anxiousness when studying, e.g., "I get tense and nervous while studying." The subscale showed adequate internal validity in the original study with an α of 0.72 in 180 adults (71% female, 58% White).

  5. Perceived Stress During the Last Month

    Time frame: Baseline and intervention completion (~10 weeks)

    Subjective stress in the last month will be measured with the ten-item Perceived Stress Scale (PSS-10). The scale evaluates individuals' perception of how uncontrollable and overloaded their lives have been in the past month, e.g., "In the past month, how often have you felt you were unable to control the important things in your life?" Participants will rate items on a five-point Likert scale from 0 (never) to 5 (very often). The possible scores range from 0 to 50; higher scores reflect more perceived stress. The scale has shown strong internal validity (α > 0.70) and test-retest reliability (r > 0.70) in a systematic review.

  6. Stress Management Self-Efficacy

    Time frame: Baseline and intervention completion (~10 weeks)

    Participants will evaluate their confidence in managing stress with the Stress Management Self-Efficacy Scale (α = 0.86, N = 2292) (Sawatzky et al., 2012). The scale has four items, e.g., "I believe I have the ability to cope with the demands of my life." All items will be rated on a four-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). A global score will be computed with the mean across the four items (range: 1 to 4), with higher scores indicating greater self-efficacy in identifying and managing stress.

  7. Anxiety

    Time frame: Baseline and intervention completion (~10 weeks)

    The severity of generalized anxiety disorder will be evaluated with the seven-item anxiety scale (GAD-7). The scale had high internal validity (α = 0.92) and test-retest reliability (interclass correlation = 0.83) in the original study. Item responses are anchored on a four-point Likert scale from 0 (not at all) to 3 (nearly every day). A total score will be computed by taking the sum of item responses. Possible scores range from 0 to 21, with higher scores reflecting more severe anxiety. A score of 8 and above indicates possible cases of GAD with a sensitivity of 83% and specificity of 84%.

  8. Heart Rate Variability Response to TSST

    Time frame: Intervention completion (~8 and 9 weeks)

    Heart rate variability response to the TSST will be assessed by the change in Root Mean Square of Successive Differences (RMSSD) during the TSST (speech preparation + speaking) compared to the baseline.

  9. Emotional Eating

    Time frame: Baseline and intervention completion (~10 weeks)

    Emotional Eating will be assessed with the 13-item Emotional Eating Subscale from the Dutch Eating Behavior Questionnaire (DEBQ) (Van Strien et al., 1986). The Emotional Eating scale has demonstrated strong internal consistency (α > 0.98) in English-speaking populations (Mason et al., 2019). Items are scored on a five-point Likert scale from 1 (never) to 5 (very often). A total score will be computed by averaging all items. Possible scores range from 1 to 5, with higher scores indicating higher rates of emotional eating (Mason et al., 2019; Van Strien et al., 1986).

Sponsors and collaborators

Lead sponsor

Trustees of Dartmouth College

Other

Collaborators

  • Dartmouth College

Registry information

Official study title

A Randomized Controlled Trial of a College Human Physiology Course With Integrated Mindfulness Practice on Student Applied and Trait Mindfulness, Well-being, and Physiological Stress Reactivity (2026)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 21, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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