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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06423053
Other study ID # STUDY00032944
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 21, 2024
Est. completion date September 1, 2024

Study information

Verified date June 2024
Source Trustees of Dartmouth College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study aims to evaluate whether integrating mindfulness practice into an undergraduate biology course influences student levels of mindfulness, stress, positive academic emotions, and physical, mental, and social health outcomes. These outcomes will be evaluated for students who enroll in the biology course compared to students who attempted to register but were put on a waitlist (waitlisted).


Description:

The proposed study aims to evaluate whether integrating mindfulness practice into an undergraduate biology course influences student levels of mindfulness, learning-related anxiety and well-being. A two-arm design will look at students who receive the intervention (academic course) plus usual care and a control group of waitlisted students for the course who will only receive 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 that provide informed consent will be enrolled. Data relating to mindfulness, learning-related anxiety, and well-being will be collected at baseline, mid-intervention (~5 weeks), at the conclusion of the intervention (~10 weeks), and at ~20 weeks. The primary analyses will evaluate whether there is a greater 1. increase in mindfulness, 2. increase in composite well-being score, and 3. decrease in learning-related anxiety in the intervention arm compared to the control arm. The secondary analyses will evaluate whether there is a greater 1. increase in heart rate variability and 2. reduction in hair cortisol in the intervention arm compared to the control arm. Secondary analyses will also evaluate differential changes in individual well-being score components (including physical activity, sleep, diet, alcohol use, media use, perceived stress, overall mental well-being, and loneliness). The analytical approach will examine if changes in outcomes are greater in the intervention group than in the usual care group via linear mixed-effect or linear regression models, as appropriate, adjusting for covariates. Statistical analyses will follow an "intention-to-treat" approach and include all participants, regardless of intervention completion. A p-value of <.05 will be used as the threshold for statistical significance for all tests. In addition, any outcomes with observed statically significant differences between the arms will be re-collected and analyzed for differences at ~10 weeks post-intervention.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date September 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Current Dartmouth student who selected Biology 3: Mindful Physiology during 2024 Spring term course enrollment period. Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Biology Course with Integrated Mindfulness
This intervention is a college biology course with embedded mindfulness practice. There are 17 class sessions, each 1 hr and 50 min. long, over 9.5 weeks. Students will be taught human physiology through didactic lectures, laboratory activities, and written tests typical for a college course. Each class meeting will have ~20 min. of mindfulness practice in Thich Nhat Hanh's Plum Village tradition. Students are recommended to practice mindfulness for 15 minutes daily. Students are assigned a daily log of their mindfulness practice, and they are given full credit for each log completion regardless of the minutes of mindfulness practices. Students are assigned a weekly written reflection to reflect on the physiology course content and/or their mindfulness practice. All students in the class are required to attend a 4-hr mindfulness retreat Students in the intervention arm will also receive university wellness resources as usual as described for the control arm below.

Locations

Country Name City State
United States Media and Health Behaviors Lab at Dartmouth Hanover New Hampshire

Sponsors (1)

Lead Sponsor Collaborator
Trustees of Dartmouth College

Country where clinical trial is conducted

United States, 

References & Publications (27)

Baer R. Assessment of mindfulness by self-report. Curr Opin Psychol. 2019 Aug;28:42-48. doi: 10.1016/j.copsyc.2018.10.015. Epub 2018 Nov 2. — View Citation

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. — View Citation

Bamber, M. D., & Schneider, J. K. (2022). College students' perceptions of mindfulness-based interventions: A narrative review of the qualitative research. Current Psychology, 41(2), 667-680. https://doi.org/10.1007/s12144-019-00592-4

Bieleke, M., Gogol, K., Goetz, T., & Pekrun, R. (in press). The AEQ-S: A short version of the Achievement Emotions Questionnaire. Contemporary Educational Psychology, 101940. Advance online publication. https://doi.org/10.1016/j.cedpsych.2020.101940

Black, D. S. (2015). Mindfulness Training for Children and Adolsecents: A State-of-the-Science Review. In Handbook of Mindfulness: Theory, Research, and Practice (pp. 283-310). Guilford Publications.

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. — View Citation

Colby S, Zhou W, Allison C, Mathews AE, Olfert MD, Morrell JS, Byrd-Bredbenner C, Greene G, Brown O, Kattelmann K, Shelnutt K. Development and Validation of the Short Healthy Eating Index Survey with a College Population to Assess Dietary Quality and Intake. Nutrients. 2020 Aug 27;12(9):2611. doi: 10.3390/nu12092611. — View Citation

Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB. — View Citation

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. — View Citation

Dum M, Sobell LC, Sobell MB, Heinecke N, Voluse A, Johnson K. A Quick Drinking Screen for identifying women at risk for an alcohol-exposed pregnancy. Addict Behav. 2009 Sep;34(9):714-6. doi: 10.1016/j.addbeh.2009.04.001. Epub 2009 Apr 8. — View Citation

Framson C, Kristal AR, Schenk JM, Littman AJ, Zeliadt S, Benitez D. Development and validation of the mindful eating questionnaire. J Am Diet Assoc. 2009 Aug;109(8):1439-44. doi: 10.1016/j.jada.2009.05.006. — View Citation

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. — View Citation

Greeson JM, Juberg MK, Maytan M, James K, Rogers H. A randomized controlled trial of Koru: a mindfulness program for college students and other emerging adults. J Am Coll Health. 2014;62(4):222-33. doi: 10.1080/07448481.2014.887571. — View Citation

John D, Tang Q, Albinali F, Intille S. An Open-Source Monitor-Independent Movement Summary for Accelerometer Data Processing. J Meas Phys Behav. 2019 Dec;2(4):268-281. doi: 10.1123/jmpb.2018-0068. — View Citation

Lee EH. Review of the psychometric evidence of the perceived stress scale. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Dec;6(4):121-7. doi: 10.1016/j.anr.2012.08.004. Epub 2012 Sep 18. — View Citation

Letourneau B, Sobell LC, Sobell MB, Agrawal S, Gioia CJ. Two Brief Measures of Alcohol Use Produce Different Results: AUDIT-C and Quick Drinking Screen. Alcohol Clin Exp Res. 2017 May;41(5):1035-1043. doi: 10.1111/acer.13364. Epub 2017 Mar 31. — View Citation

Li K, Cardoso C, Moctezuma-Ramirez A, Elgalad A, Perin E. Heart Rate Variability Measurement through a Smart Wearable Device: Another Breakthrough for Personal Health Monitoring? Int J Environ Res Public Health. 2023 Dec 6;20(24):7146. doi: 10.3390/ijerph20247146. — View Citation

Li MJ, Black DS, Garland EL. The Applied Mindfulness Process Scale (AMPS): A process measure for evaluating mindfulness-based interventions. Pers Individ Dif. 2016 Apr 1;93:6-15. doi: 10.1016/j.paid.2015.10.027. — View Citation

Liu D, Kahathuduwa C, Vazsonyi AT. The Pittsburgh Sleep Quality Index (PSQI): Psychometric and clinical risk score applications among college students. Psychol Assess. 2021 Sep;33(9):816-826. doi: 10.1037/pas0001027. Epub 2021 May 20. — View Citation

Loucks EB, Nardi WR, Gutman R, Saadeh FB, Li Y, Vago DR, Fiske LB, Spas JJ, Harrison A. Mindfulness-Based College: A Stage 1 Randomized Controlled Trial for University Student Well-Being. Psychosom Med. 2021 Jul-Aug 01;83(6):602-614. doi: 10.1097/PSY.0000000000000860. — View Citation

Mccullough ME, Emmons RA, Tsang JA. The grateful disposition: a conceptual and empirical topography. J Pers Soc Psychol. 2002 Jan;82(1):112-27. doi: 10.1037//0022-3514.82.1.112. — View Citation

Neff, K.D. The Self-Compassion Scale is a Valid and Theoretically Coherent Measure of Self-Compassion. Mindfulness 7, 264-274 (2016). https://doi.org/10.1007/s12671-015-0479-3

Shapiro, S. L., & Jazaieri, H. (2015). Mindfulness-Based Stress Reduction for Healthy Stressed Adults. In Handbook of mindfulness: Theory, research, and practice (pp. 269-282). The Guilford Press.

Sobell LC, Agrawal S, Sobell MB, Leo GI, Young LJ, Cunningham JA, Simco ER. Comparison of a quick drinking screen with the timeline followback for individuals with alcohol problems. J Stud Alcohol. 2003 Nov;64(6):858-61. doi: 10.15288/jsa.2003.64.858. — View Citation

Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63. — View Citation

Wright KD, Hickman R, Laudenslager ML. Hair Cortisol Analysis: A Promising Biomarker of HPA Activation in Older Adults. Gerontologist. 2015 Jun;55 Suppl 1(Suppl 1):S140-5. doi: 10.1093/geront/gnu174. — View Citation

* Note: There are 27 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Trait Mindfulness Trait mindfulness will be measured via the Five Facet Mindfulness Questionnaire (FFMQ; total possible score range: 1-5; higher scores indicate higher trait mindfulness). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Primary Applied Mindfulness Application of mindfulness in everyday life will be measured via the Applied Mindfulness Process Scale (AMPS; total possible score range: 0-60; higher scores indicate more application of mindfulness practice in daily life). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Primary Composite Well-Being Score This composite score is the average z-score of 8 physical and emotional health metrics (Loucks et al., 2021). They are (1) sleep (5-day accelerometry and/or Pittsburg Sleep Quality Index; score range: 0-21; higher scores = poorer sleep quality), (2) physical activity (International Physical Activity Questionnaire and/or 5-day accelerometry), (3) diet (short Health Eating Index; range: 0-100; higher scores = higher diet quality) and (4) alcohol intake (Quick Drinking Screen), (5) media use (Bergen Social Media Addiction Scale; range: 6-30; higher scores = more problematic media use), (6) mental stress (Perceived Stress Scale-10; range: 0-40; higher scores = more perceived stress), (7) mental well-being (Warwick-Edinburgh Mental Well-being Scale; range: 14-70; higher scores = more mental well-being), and (8) loneliness (UCLA-Loneliness Scale; range: 0-60; higher scores = more perceived loneliness). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Primary Learning-Related Anxiety Learning-related anxiety subscale from the Achievement Emotion Questionnaire-short version (AEQ-S; total possible score range: 1-5; higher scores indicate greater learning-related anxiety). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary Self-Compassion Measured via Self-Compassion Scale (; total possible score range: 1-5; higher scores indicate higher levels of self-compassion). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary Mindful Eating Measured via Mindful Eating Questionnaire (MEQ; total possible score range: 1-4; higher scores indicate more mindful eating). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary Trait Gratitude Measured via Gratitude Questionnaire (GQ-6; total possible score range: 1-7; higher scores indicate higher levels of trait gratitude). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary Self-Report Sleep Measured via the Pittsburg Sleep Quality Index (PSQI, total possible score range: 0-21; higher scores indicate poorer sleep quality). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary Self-Report Physical Activity Measured via the International Physical Activity Questionnaire (total multiples of the resting metabolic rate (MET) minutes per week in the past week). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary Diet Quality Measured via the short Health Eating Index (sHEI, possible total score range: 0-100; higher scores indicate higher diet quality). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary Alcohol Intake Measured via the Quick Drinking Screen (i.e., the number of standard drinks per week). One standard drink is one 12-oz. regular can or glass of beer, one 5-oz. glass of regular wine, or one 1/2-oz. of regular-proof hard liquor or spirits. Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary Media Use Measured via the Bergen Social Media Addiction Scale (BSMAS, total possible score ranges from 6-30; higher scores indicate more problematic media use). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary Perceived Stress Measured via the Perceived Stress Scale, 10-item version (PSS-10; total possible score range: 0-40; higher scores indicate more perceived stress). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary Subjective Well-being Measured via the Warwick-Edinburgh Mental Well-being Scale (WEMWBS, total possible score range: 14-70; higher scores show greater mental well-being). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary Social Connectedness Measured via the UCLA-Loneliness Scale (total score range: 0-60; higher scores show more perceived loneliness). Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)
Secondary Physiologic Stress (HRV) Measured via a polar chest strap for 24 hours. Baseline and intervention completion(~10 weeks)
Secondary Physiologic Stress (Cortisol) Measured via hair cortisol concentration. Baseline and intervention completion (~10 weeks)
Secondary Actigraphy-Assessed Sleep Measured via a wrist-worn accelerometer for 5 days. Baseline and intervention completion (~10 weeks)
Secondary Actigraphy-Assessed Physical Activity Measured via a wrist-worn accelerometer for 5 days. Baseline and intervention completion (~10 weeks)
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