Mindfulness-Based Intervention With a Supplement for Stress-Related Problems in College Students Across Multiple Sites (4SITE)

The investigators hope to add to the feasible, acceptable, and effective interventions that offer reductions in depression, anxiety, and stress for students at U.S. colleges and universities, the majority of whom experience mental health problems but the minority of whom who receive adequate mental health support. By studying the extent to which a multi-modal supplement boosts effects for a mindfulness-based intervention (and comparing both to an active health education control program) to reduce depression, anxiety, and stress, the proposed research seeks to rigorously investigate complementary and integrative health interventions and their roles in improving health.

NCT Number	NCT07098845
Lead Sponsor	Colorado State University Collaborators: University of Minnesota, National Center for Complementary and Integrative Health (NCCIH), University of Colorado, Denver, Macalester College
Conditions	Stress, Mental Health, Mindfulness Based Stress Reduction
Enrollment	120 participants
Start Date	2025-09-01
Primary Completion	2026-10-01 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-10