[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06423053":3,"trial-entities:NCT06423053":137,"trial-summary:NCT06423053":141},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":57,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":79,"overall_officials":80,"references":84,"see_also_links":136},"NCT06423053","STUDY00032944","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)","ENROLLING_BY_INVITATION","2026-09-01","2026-04","2026-04-08","2026-03-30","Trustees of Dartmouth College","OTHER",false,"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.\n\nThe primary questions are\n\n1. Would completing the Mindful Physiology course increase applied mindfulness?\n2. Would completing the class increase trait mindfulness?\n3. Would completing the class increase subjective well-being?\n4. Would completing the class reduce physiological stress response to an acute social stressor?","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.\n\nData 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.\n\nThis 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.\n\nFor 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.\n\nAs 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 \\\u003C 0.05 as statistically significant.",[19,20,21],"Mindfulness","Stress","Well-being",[19,23,20,24,25,26,27],"College student","Applied mindfulness","young adults","well-being","stress reactivity","INTERVENTIONAL","PREVENTION",[31],"NA",{"count":33,"type":34},89,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","Biology Course with Integrated Mindfulness","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.",[41],"Biology 3 students",[43,47,50,54],{"measure":44,"description":45,"timeFrame":46},"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)",{"measure":48,"description":49,"timeFrame":46},"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.",{"measure":51,"description":52,"timeFrame":53},"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)",{"measure":55,"description":56,"timeFrame":46},"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.",[],"ALL","18 Years",null,true,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"Inclusion criteria: 1. Undergraduate students who selected Biology 3: Mindful Physiology during the 2026 Spring term course enrollment period.",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Dartmouth College","Hanover","New Hampshire","03755","United States",{"lat":77,"lon":78},43.70229,-72.28954,[],[81],{"name":82,"affiliation":71,"role":83},"Diane Gilbert-Diamond, ScD","PRINCIPAL_INVESTIGATOR",[85,89,92,94,97,100,103,106,109,112,115,118,121,124,127,130,133],{"pmid":86,"type":87,"citation":88},"39442231","BACKGROUND","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\u002Fj.psyneuen.2024.107211. Epub 2024 Oct 11.",{"pmid":90,"type":87,"citation":91},"26999354","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\u002Fadb0000160.",{"type":87,"citation":93},"Stress and Quality of Life Among University Students: A Systematic Literature Review. Health Professions Education,",{"pmid":95,"type":87,"citation":96},"30422199","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. 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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\u002Fijerph18020739.",{"pmid":107,"type":87,"citation":108},"22166906","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\u002FNNR.0b013e31823b1440.",{"pmid":110,"type":87,"citation":111},"21584907","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\u002Fcpp.702. Epub 2010 Jun 8.",{"pmid":113,"type":87,"citation":114},"26719105","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\u002Fj.genhosppsych.2015.11.005. Epub 2015 Nov 18.",{"pmid":116,"type":87,"citation":117},"34240661","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\u002F17538157.2021.1923500. Epub 2021 Jul 9.",{"pmid":119,"type":87,"citation":120},"23527521","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\u002Fa0032200. Epub 2013 Mar 25.",{"pmid":122,"type":87,"citation":123},"38250521","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\u002Fs12671-023-02212-6. Epub 2023 Sep 22.",{"pmid":125,"type":87,"citation":126},"18929686","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\u002Fj.jbi.2008.08.010. Epub 2008 Sep 30.",{"pmid":128,"type":87,"citation":129},"29422189","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\u002FS2468-2667(17)30231-1. Epub 2017 Dec 19.",{"pmid":131,"type":87,"citation":132},"31743957","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\u002Faphw.12188. Epub 2019 Nov 19.",{"pmid":134,"type":87,"citation":135},"16443717","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\u002F1073191105283504.",[],{"nct_id":4,"conditions":138,"biomarkers":140},[139,20,21],"College Student",[],{"nct_id":4,"found":15,"summary":60,"prompt_version":60}]