- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06423053
Mindfulness in a College Physiology Course
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
- Would completing the Mindful Physiology course increase applied mindfulness?
- Would completing the class increase trait mindfulness?
- Would completing the class increase subjective well-being?
- Would completing the class reduce physiological stress response to an acute social stressor?
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Hampshire
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Hanover, New Hampshire, United States, 03755
- Dartmouth College
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Biology 3 students
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.
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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.
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No Intervention: Biology 3 waitlisted students
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Applied Mindfulness
Time Frame: Baseline and intervention completion (~10 weeks)
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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.
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Baseline and intervention completion (~10 weeks)
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Trait Mindfulness
Time Frame: Baseline and intervention completion (~10 weeks)
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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.
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Baseline and intervention completion (~10 weeks)
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Physiological Stress Response to an Acute Stressor
Time Frame: Intervention completion (~8 and 9 weeks)
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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.
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Intervention completion (~8 and 9 weeks)
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Well-Being
Time Frame: Baseline and intervention completion (~10 weeks)
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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.
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Baseline and intervention completion (~10 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Compassion
Time Frame: Baseline and intervention completion (~10 weeks)
|
Self-compassion will be measured with the Self-Compassion Scale short-form (SCS-SF).
This 12-item questionnaire evaluates how often one treats themselves with kindness rather than judgment during challenging moments.
This instrument showed high internal validation in the original study (α ≥ .86)
and correlated highly (r ≥ 0.97) with the original 33-item Self-Compassion Scale.
The total possible score ranges from 1 to 5. Higher scores indicate more self-compassion.
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Baseline and intervention completion (~10 weeks)
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Overall Well-Being
Time Frame: Baseline and intervention completion (~10 weeks)
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Overall well-being will be assessed with the ten-item Flourish measure.
This self-report instrument has five domains: (1) life satisfaction (e.g., "In general, how happy or unhappy do you usually feel?"), (2) mental and physical health (e.g., "How would you rate your physical health?"),
(3) meaning and purpose (e.g., "I understand my purpose in life."),
(4) character and virtue (e.g., "I always act to promote good in all circumstances, even in difficult and challenging situations."), and (5) social relationships (e.g., "I am content with my friendships and relationships").
Items will be rated on a scale from 0 to 10, with higher scores reflecting more positive well-being.
A total score will be computed by summing item responses (range: 0 to 50).
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Baseline and intervention completion (~10 weeks)
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Social Connectedness
Time Frame: Baseline and intervention completion (~10 weeks)
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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.
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Baseline and intervention completion (~10 weeks)
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Mental Well-Being
Time Frame: Baseline and intervention completion (~10 weeks)
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Psychological 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.
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Baseline and intervention completion (~10 weeks)
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Resillience
Time Frame: Baseline and intervention completion (~10 weeks)
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Resilience to stress will be measured with the Brief Resilience Scale (BRS).
The scale has six items on the ability to recover from difficulties in life, e.g., "I tend to bounce back quickly after hard times."
Responses are anchored on a five-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).
The final score is the mean across the items, ranging from 1 to 5. Higher scores indicate more resilience.
The scale demonstrated high internal validity with α ranging from 0.84 and 0.87 in two samples of US undergraduate students.
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Baseline and intervention completion (~10 weeks)
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Learning-Related Anxiety
Time Frame: Baseline and intervention completion (~10 weeks)
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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).
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Baseline and intervention completion (~10 weeks)
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Social Media Addiction
Time Frame: Baseline and intervention completion (~10 weeks)
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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).
|
Baseline and intervention completion (~10 weeks)
|
|
Alcohol Intake
Time Frame: Baseline and intervention completion (~10 weeks)
|
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.
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Baseline and intervention completion (~10 weeks)
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Physiological Stress in Response to an Acute Stressor
Time Frame: Intervention completion (~8 and 9 weeks)
|
During the TSST, heart rate will be collected via a chest-worn monitor Polar H10 chest strap device (Polar Electro Oy, Kempele, Finland) and video-based photoplethysmography (PPG) (GoPro 9, San Mateo, US).
The mean of the heart rate (HR), heart rate variability (HRV), and respiratory sinus arrhythmia (RSA) will be computed for three phases: the last 5 minutes of the baseline resting period, the last 3 minutes of the TSST, and the last 5 minutes of the recovery phase.
Reactivity to the acute stressor will be operationalized as the differences in heart rate parameters during the TSST from the baseline.
Recovery from the acute stressor will be operationalized as the difference between the recovery phase and baseline.
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Intervention completion (~8 and 9 weeks)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and intervention completion (~10 weeks)
|
|
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).
|
Baseline and intervention completion (~10 weeks)
|
|
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).
|
Baseline and intervention completion (~10 weeks)
|
|
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.
|
Baseline and intervention completion (~10 weeks)
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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%.
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Baseline and intervention completion (~10 weeks)
|
|
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.
|
Baseline and intervention completion (~10 weeks)
|
|
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.
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Baseline and intervention completion (~10 weeks)
|
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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.
|
Intervention completion (~8 and 9 weeks)
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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).
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Baseline and intervention completion (~10 weeks)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Diane Gilbert-Diamond, ScD, Dartmouth College
Publications and helpful links
General Publications
- 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.
- Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
- 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.
- 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.
- 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.
- 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.
- 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.
- Dawson AF, Brown WW, Anderson J, Datta B, Donald JN, Hong K, Allan S, Mole TB, Jones PB, Galante J. Mindfulness-Based Interventions for University Students: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Appl Psychol Health Well Being. 2020 Jul;12(2):384-410. doi: 10.1111/aphw.12188. Epub 2019 Nov 19.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00032944
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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