NCT06423053

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

March 21, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

March 21, 2024

Last Update Submit

April 2, 2026

Conditions

Keywords

MindfulnessCollege studentStressApplied mindfulnessyoung adultswell-beingstress reactivity

Outcome Measures

Primary Outcomes (4)

  • 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.

    Baseline and intervention completion (~10 weeks)

  • 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.

    Baseline and intervention completion (~10 weeks)

  • 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.

    Intervention completion (~8 and 9 weeks)

  • 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.

    Baseline and intervention completion (~10 weeks)

Other Outcomes (9)

  • Harmful Alcohol Intake

    Baseline and intervention completion (~10 weeks)

  • Social Media Addiction

    Baseline and intervention completion (~10 weeks)

  • Social Connectedness

    Baseline and intervention completion (~10 weeks)

  • +6 more other outcomes

Study Arms (2)

Biology 3 students

EXPERIMENTAL

This 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.

Behavioral: Biology Course with Integrated Mindfulness

Biology 3 waitlisted students

NO INTERVENTION

This 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.

Interventions

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.

Biology 3 students

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth College

Hanover, New Hampshire, 03755, United States

Location

Related Publications (17)

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    PMID: 39442231BACKGROUND
  • 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.

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

    BACKGROUND
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    PMID: 30422199BACKGROUND
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    PMID: 28705870BACKGROUND
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    PMID: 39205975BACKGROUND
  • 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.

    PMID: 33467118BACKGROUND
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    PMID: 22166906BACKGROUND
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    PMID: 21584907BACKGROUND
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    PMID: 26719105BACKGROUND
  • 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.

    PMID: 34240661BACKGROUND
  • 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.

    PMID: 23527521BACKGROUND
  • 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.

    PMID: 38250521BACKGROUND
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    PMID: 18929686BACKGROUND
  • 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.

    PMID: 29422189BACKGROUND
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    PMID: 31743957BACKGROUND
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    PMID: 16443717BACKGROUND

Study Officials

  • Diane Gilbert-Diamond, ScD

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Principal Investigator

Study Record Dates

First Submitted

March 21, 2024

First Posted

May 21, 2024

Study Start

March 30, 2026

Primary Completion (Estimated)

June 3, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will become available on October 1, 2027.
Access Criteria
Data Sharing Agreement Institutional Human Subjects Research Protocol Approval

Locations