AzTrials
AzTrials

MindfulnessNCT06423053

Mindfulness in a College Physiology Course

A study testing Biology Course with Integrated Mindfulness in people with Mindfulness and Stress, run by Trustees of Dartmouth College at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mindfulness, Stress, Well-being
What is being tested?
Biology Course with Integrated Mindfulness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
16 Mar 2026to 10 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Dartmouth College

    Hanover, New Hampshire, 03755

Other trials in United States

About this study

Official 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)

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?
Read the detailed description

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.

Being tested
Biology Course with Integrated Mindfulness
Keywords
Mindfulness, College student, Stress, Applied mindfulness, young adults, well-being, stress reactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biology Course with Integrated MindfulnessBehavioural

    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.

Study groups in NCT06423053
Study groupRoleWhat they receive
Biology 3 studentsExperimentalThis arm consists of students enrolled in the Mindful Physiology course (Biology 3) at Dartmouth College during the Spring 2026 term who will have access to the course offerings and usual university wellness resources.
Receives: Behavioral: Biology Course with Integrated Mindfulness
Biology 3 waitlisted studentsNo interventionThis arm consists of students waitlisted for the Biology 3 course during the Spring 2026 term. They receive university wellness resources as usual. These include access to wellness counselors, mental health advisors, and psychiatrists 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. On-campus mindfulness retreats will also be advertised and accessible to the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Applied Mindfulness

    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.

    Measured: Baseline and intervention completion (~10 weeks)

  2. Trait Mindfulness

    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.

    Measured: Baseline and intervention completion (~10 weeks)

  3. Physiological Stress Response to an Acute Stressor

    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.

    Measured: Intervention completion (~8 and 9 weeks)

  4. Well-Being

    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.

    Measured: Baseline and intervention completion (~10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2024
  2. Study start16 Mar 2026
  3. Primary completion10 Jun 2026
  4. Study completion10 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The intervention group will consist of students enrolled in the Mindful Physiology course (Biology 3) at Dartmouth College in the spring 2026 term (3/30/2026- 6/3/2026). The control group will enroll students waitlisted for the course during the Spring 2026 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.
Masking
Single blind
Who is masked
Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06423053
Sponsor's protocol ID
STUDY00032944
Status last verified
Oct 2026
First submitted
21 Mar 2024
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified participant data will be made available to other researchers upon reasonable requests to the Principal Investigator with a data sharing agreement provided that the researchers have appropriate human subjects research approval.

Publications

  • Heyers K, Pfeifer LS, Merz CJ, Stockhorst U, Gunturkun O, Wolf OT, Ocklenburg S. TSST-OL: Comparison between online and laboratory application and effects on empathy. Psychoneuroendocrinology. 2025 Jan;171:107211. doi: 10.1016/j.psyneuen.2024.107211. Epub 2024 Oct 11.

    PubMed 39442231
  • Schou Andreassen C, Billieux J, Griffiths MD, Kuss DJ, Demetrovics Z, Mazzoni E, Pallesen S. The relationship between addictive use of social media and video games and symptoms of psychiatric disorders: A large-scale cross-sectional study. Psychol Addict Behav. 2016 Mar;30(2):252-62. doi: 10.1037/adb0000160.

    PubMed 26999354
  • Stress and Quality of Life Among University Students: A Systematic Literature Review. Health Professions Education,

  • US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening and Behavioral Counseling Interventions to Reduce Unhealthy Alcohol Use in Adolescents and Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Nov 13;320(18):1899-1909. doi: 10.1001/jama.2018.16789.

    PubMed 30422199
  • VanderWeele TJ. On the promotion of human flourishing. Proc Natl Acad Sci U S A. 2017 Aug 1;114(31):8148-8156. doi: 10.1073/pnas.1702996114. Epub 2017 Jul 13.

    PubMed 28705870
  • Zhang Z, Luu BCP, Gilbert-Diamond D. Acceptability, engagement, and preliminary efficacy of a college human physiology course with integrated mindfulness practice to support student wellbeing. Front Psychol. 2024 Aug 14;15:1365778. doi: 10.3389/fpsyg.2024.1365778. eCollection 2024.

    PubMed 39205975
  • Wunsch K, Fiedler J, Bachert P, Woll A. The Tridirectional Relationship among Physical Activity, Stress, and Academic Performance in University Students: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jan 16;18(2):739. doi: 10.3390/ijerph18020739.

    PubMed 33467118
  • Sawatzky RG, Ratner PA, Richardson CG, Washburn C, Sudmant W, Mirwaldt P. Stress and depression in students: the mediating role of stress management self-efficacy. Nurs Res. 2012 Jan-Feb;61(1):13-21. doi: 10.1097/NNR.0b013e31823b1440.

    PubMed 22166906
  • Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

    PubMed 21584907
  • Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016 Mar-Apr;39:24-31. doi: 10.1016/j.genhosppsych.2015.11.005. Epub 2015 Nov 18.

    PubMed 26719105
  • Pirzada P, Wilde A, Doherty GH, Harris-Birtill D. Ethics and acceptance of smart homes for older adults. Inform Health Soc Care. 2022 Jan 2;47(1):10-37. doi: 10.1080/17538157.2021.1923500. Epub 2021 Jul 9.

    PubMed 34240661
  • Nyklicek I, Mommersteeg PM, Van Beugen S, Ramakers C, Van Boxtel GJ. Mindfulness-based stress reduction and physiological activity during acute stress: a randomized controlled trial. Health Psychol. 2013 Oct;32(10):1110-3. doi: 10.1037/a0032200. Epub 2013 Mar 25.

    PubMed 23527521
  • Johnson BT, Acabchuk RL, George EA, Nardi W, Sun S, Salmoirago-Blotcher E, Scharf J, Loucks EB. Mental and Physical Health Impacts of Mindfulness Training for College Undergraduates: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Mindfulness (N Y). 2023 Sep;14(9):2077-2096. doi: 10.1007/s12671-023-02212-6. Epub 2023 Sep 22.

    PubMed 38250521
  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

    PubMed 18929686
  • Galante J, Dufour G, Vainre M, Wagner AP, Stochl J, Benton A, Lathia N, Howarth E, Jones PB. A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial. Lancet Public Health. 2018 Feb;3(2):e72-e81. doi: 10.1016/S2468-2667(17)30231-1. Epub 2017 Dec 19.

    PubMed 29422189

Questions about this trial

What is this clinical trial studying?

A study testing Biology Course with Integrated Mindfulness in people with Mindfulness and Stress, run by Trustees of Dartmouth College at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Applied Mindfulness (time frame: Baseline and intervention completion (~10 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06423053, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in