## Protocol Section
### Identification Module
**NCT ID:** NCT06423053

**Brief Title:** A Randomized Trial of a College Biology Course With Integrated Mindfulness

**Official Title:** A Randomized Trial of a College Biology Course With Integrated Mindfulness Practice on Student Mindfulness, Learning-Related Anxiety, and Well-Being

#### Organization Study ID Info
**ID:** STUDY00032944
#### Organization
**Class:** OTHER
**Full Name:** Trustees of Dartmouth College
### Status Module
#### Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-21

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-21
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Trustees of Dartmouth College

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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 waitlisted.

**Detailed 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.

### Conditions Module

**Conditions:**

- Mindfulness

- Stress Psychological

- Stress, Physiological

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Students who attempted to enroll in Biology 3: Mindful Physiology at Dartmouth College during the course selection period were randomly assigned to the class or waitlist by the college registrar. The intervention is participation in Biology 3, a college biology course with integrated mindfulness practices along with usual access to the College's wellness offerings. The control condition is the waitlist for Biology 3 along with usual access to the College's wellness offerings.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This arm consists of students enrolled in Dartmouth College's Biology 3 course during Spring 2024 term, who will have access to course offerings and usual university wellness resources (as described for the control arm).

**Intervention Names:**

- Behavioral: Biology Course with Integrated Mindfulness

**Label:** Biology 3 students

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** This arm consists of students waitlisted for Dartmouth College's Biology 3 course during Spring 2024 term. They will 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. The 4-hr mindfulness retreat will also be advertised to and open to all Dartmouth students.

**Label:** Biology 3 waitlisted students

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Biology 3 students

**Description:** 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.

**Name:** Biology Course with Integrated Mindfulness

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Trait mindfulness will be measured via the Five Facet Mindfulness Questionnaire (FFMQ; total possible score range: 1-5; higher scores indicate higher trait mindfulness).

**Measure:** Trait Mindfulness

**Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)

**Description:** 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).

**Measure:** Applied Mindfulness

**Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)

**Description:** A well-being score assessing physical, emotional, and social health and behaviors, adapted from Loucks et al. (2021): sleep (5-day accelerometry and/or Pittsburg Sleep Quality Index, total possible score range: 0-21; higher scores indicate poorer sleep quality), physical activity (International Physical Activity Questionnaire and/or 5-day accelerometry), diet (short Health Eating Index; range: 0-100; higher scores indicate higher diet quality), alcohol intake (Quick Drinking Screen), media use (Bergen Social Media Addiction Scale; range: 6-30; higher scores indicate more problematic media use), stress (Perceived Stress Scale-10; range: 0-40; higher scores indicate more perceived stress), mental well-being (Warwick-Edinburgh Mental Well-being Scale; range: 14-70; higher scores show more mental well-being), and loneliness (UCLA-Loneliness Scale; range: 0-60; higher scores show more perceived loneliness). This composite score will be the mean z-score across the above-mentioned measures.

**Measure:** Composite Well-Being Score

**Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)

**Description:** 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).

**Measure:** Learning-Related Anxiety

**Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)

#### Secondary Outcomes

**Description:** Measured via a polar chest strap for 24 hours

**Measure:** Physiologic Stress (HRV)

**Time Frame:** Baseline and intervention completion(~10 weeks)

**Description:** Measured via hair cortisol concentration

**Measure:** Physiologic Stress (Cortisol)

**Time Frame:** Baseline and intervention completion (~10 weeks)

**Description:** Measured via Self-Compassion Scale (; total possible score range: 1-5; higher scores indicate higher levels of self-compassion)

**Measure:** Self-Compassion

**Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)

**Description:** Measured via Gratitude Questionnaire (GQ-6; total possible score range: 1-7; higher scores indicate higher levels of trait gratitude)

**Measure:** Trait Gratitude

**Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)

**Description:** Measured via Mindful Eating Questionnaire (MEQ; total possible score range: 1-4; higher scores indicate more mindful eating)

**Measure:** Mindful Eating

**Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)

**Description:** Each component of the composite well-being score described above will be assessed separately in secondary analyses.

**Measure:** Components of Composite Well-Being Score

**Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Current Dartmouth student who selected Biology 3: Mindful Physiology during 2024 Spring term course enrollment period.

Exclusion Criteria:

-

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hanover

**Country:** United States

**Facility:** Media and Health Behaviors Lab at Dartmouth

**State:** New Hampshire

**Zip:** 03755

#### Overall Officials

**Official 1:**

**Affiliation:** Dartmouth College

**Name:** Diane I Gilbert-Diamond, ScD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Data Sharing Agreement Institutional Human Subjects Research Protocol Approval

**Description:** De-identified participant data will be made available to other researchers upon request to the Principal Investigator with a data sharing agreement provided that the researchers have appropriate human subjects research approval.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** Data will become available October 1, 2026.

### References Module

#### References

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**PMID:** 30423507

**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.

**PMID:** 16443717

**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

**Citation:** 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.

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## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
