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Mindfulness-Based Intervention With a Supplement for Stress-Related Problems in College Students Across Multiple Sites (4SITE)
NCT07098845 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Learning to BREATHE
- BEHAVIORAL Learning to BREATHE Plus
- BEHAVIORAL HealthEd
Study Locations (4)
Colorado
- University of Colorado Denver — Denver
- Colorado State University — Fort Collins
Minnesota
- Macalester College — Saint Paul
- University of Minnesota — Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-09-01 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07098845
The ClinicalTrials.gov registry entry for NCT07098845 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Colorado State University, which has 92 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Stress appearing as the primary indexed condition, and to 3 interventions — of which Learning to BREATHE is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07098845 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Colorado, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07098845 about?
NCT07098845 is a clinical study titled "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 ...
What is the current status of trial NCT07098845?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2025-09-01. Estimated completion is 2026-12.
What conditions does trial NCT07098845 study?
This clinical trial studies the following conditions: Stress, Mental Health, Mindfulness Based Stress Reduction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07098845?
The interventions under investigation include: Learning to BREATHE (BEHAVIORAL), Learning to BREATHE Plus (BEHAVIORAL), HealthEd (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07098845?
This trial is sponsored by Colorado State University, which has 92 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07098845 being conducted?
This trial has 4 study locations across Colorado, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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