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临床试验/NCT06423053
NCT06423053
Enrolling By Invitation
不适用

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)

Trustees of Dartmouth College1 个研究点 分布在 1 个国家目标入组 89 人2026年3月30日

概览

阶段
不适用
干预措施
Biology Course with Integrated Mindfulness
疾病 / 适应症
Well-being
发起方
Trustees of Dartmouth College
入组人数
89
试验地点
1
主要终点
Trait Mindfulness
状态
Enrolling By Invitation
最后更新
24天前

概览

简要总结

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?

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2026年3月30日
结束日期
2026年9月1日
最后更新
24天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Diane Gilbert-Diamond

Professor, Principal Investigator

Trustees of Dartmouth College

入排标准

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Biology Course with Integrated Mindfulness

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.

结局指标

主要结局

Trait Mindfulness

时间窗: Baseline and intervention completion (~10 weeks)

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.

Physiological Stress Response to an Acute Stressor

时间窗: Intervention completion (~8 and 9 weeks)

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.

Well-Being

时间窗: Baseline and intervention completion (~10 weeks)

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.

Applied Mindfulness

时间窗: Baseline and intervention completion (~10 weeks)

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.

Stress Management Self-Efficacy

时间窗: 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). The scale has four items, e.g., "I believe I have the ability to cope with the demands of my life." Additionally, students will answer three items from the Stress Management Self-Efficacy Measure on self-efficacy in recognizing the physiological responses to stress. The items are (1) I am confident identifying the causes of stress, (2) I am confident identifying physiological indicators of stress, and (3) I am confident predicting the consequences of stress. 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 seven items (range: 1 to 4), with higher scores indicating greater self-efficacy in identifying and managing stress.

Perceived Stress in Response to an Acute Stressor

时间窗: Intervention completion (~8 and 9 weeks)

Stress reactivity will be assessed during an in-person lab visit with the online Trier Social Stress Test (TSST-OL). The TSST-OL is a computerized stress induction protocol, including 5 minutes of brief preparation, 5 minutes of public speaking (job interview), and 5 minutes of a math test in front of a panel of evaluators online. Our protocol will be modified to use a pre-recorded video of the panel of evaluators to give the impression of a live audience and minimize research assistant time while maintaining the conditions of the established TSST-OL. Perceived stress will be assessed at baseline (five minutes before the speech preparation) and immediately after the TSST with the Subjective Units of Distress Scale (SUDS). Participants will rate their level of distress from 0 (totally relaxed) to 100 (highest distress). Perceived stress reactivity will be operationalized as the difference between the post-TSST and baseline ratings.

次要结局

  • Social Connectedness(Baseline and intervention completion (~10 weeks))
  • Self-Compassion(Baseline and intervention completion (~10 weeks))
  • Overall Well-Being(Baseline and intervention completion (~10 weeks))
  • Mental Well-Being(Baseline and intervention completion (~10 weeks))
  • Resillience(Baseline and intervention completion (~10 weeks))
  • Learning-Related Anxiety(Baseline and intervention completion (~10 weeks))
  • Social Media Addiction(Baseline and intervention completion (~10 weeks))
  • Alcohol Intake(Baseline and intervention completion (~10 weeks))
  • Physiological Stress in Response to an Acute Stressor(Intervention completion (~8 and 9 weeks))

研究点 (1)

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