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

Study acronym: 4SITE
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 10, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: May 2026 to Oct 1, 2026
    • Site details revised at 4 of 4 sites
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2025 to Sep 1, 2025
    • Site details revised at 4 of 4 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Stress, Mental Health, Mindfulness Based Stress Reduction
Related terms Psychological Well-Being
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov