Mindfulness program with a multi-modal supplement to reduce stress in college students
Testing a Mindfulness-Based Intervention With a Multi-Modal Adaptive Supplement for Stress-Related Problems in College Students
This will test whether adding a multi-modal supplement to a group mindfulness program reduces depression, anxiety, and stress in college students with elevated stress.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 25 Years |
| Sex | All |
| Sponsor | Colorado State University Academic / other |
| Locations | 4 sites (Denver, Colorado and 3 other locations) |
| Trial ID | NCT07098845 on ClinicalTrials.gov |
What this trial studies
This multisite interventional study enrolls college students aged 18–25 who report elevated stress and randomizes them to one of three group programs: Learning To BREATHE (an evidence-based mindfulness course), Learning To BREATHE PLUS (the same course plus a multi-modal adaptive supplement), or an active health education control. Participants attend in-person sessions at one of three campuses and, for the supplement arm, use smartphone-supported tools and other supports between sessions. Primary outcomes are changes in depression, anxiety, and perceived stress measured before and after the intervention and at follow-up in the subsequent semester. The trial emphasizes feasibility and acceptability while testing whether the supplement increases the size of mindfulness-related benefits.
Who should consider this trial
Good fit: Enrolled college or university students aged 18–25 who report elevated stress, plan to be available in-person the following semester, and own a smartphone are ideal candidates.
Not a fit: Students who have multiple depressive symptoms or active suicidal ideation (and thus are excluded), or those who need intensive clinical treatment for severe mental illness, are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this approach could offer a scalable, campus-friendly program that reduces students' depression, anxiety, and stress.
How similar studies have performed: Previous mindfulness-based interventions for college students have shown small-to-moderate reductions in stress and depression and technology supplements have sometimes improved outcomes, but the specific L2B PLUS multi-modal adaptive supplement is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged 18-25 years * enrolled in a college or university * experiencing elevated stress * plan to be available in-person in the semester following the study * own a smart phone. Exclusion Criteria: * have several depressive symptoms * have suicidal ideation.
Where this trial is running
Denver, Colorado and 3 other locations
- University of Colorado Denver — Denver, Colorado, United States (Recruiting)
- Colorado State University — Fort Collins, Colorado, United States (Recruiting)
- Macalester College — Saint Paul, Minnesota, United States (Recruiting)
- University of Minnesota — Saint Paul, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Rachel Lucas-Thompson, Dr. — Colorado State University
- Study coordinator: Rachel Lucas-Thompson, PhD
- Email: lucas-thompson.rachel.graham@colostate.edu
- Phone: 970-491-5718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.