Mindfulness for Stress in College Students (4SITE)

This study is testing different mindfulness-based programs to help college students with stress and mental health. It compares "Learning to BREATHE" (L2B), which teaches focused attention and compassion, with "Learning to BREATHE Plus" (L2B PLUS), which adds an online library. Both are also compared to "HealthEd," a health education program covering topics like substance use and depression. The goal is to see if these programs can reduce depression, anxiety, and stress. You can join if you are 18-25 years old, a college student, have elevated stress, and own a smartphone. You cannot join if you have severe depressive symptoms or suicidal thoughts. The study aims to recruit 120 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 120 participants. It compares three different behavioral interventions.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures program knowledge and stress levels at various points, including 2 months before the start of the program and within a 12-month period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07098845

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

Active, Not Recruiting
NAAges 18–25InterventionalPrevention
Colorado State University
~120 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Learning to BREATHELearning to BREATHE PlusHealthEd

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Program-specific intervention knowledge evaluations
Measured over 2 months before baseline
+10 more outcomes measured
Stress
Mental Health
Mindfulness Based Stress Reduction
4 sites across 2 states
Colorado2
Minnesota2
  • Rachel Lucas-Thompson, Dr. · PRINCIPAL_INVESTIGATOR · Colorado State University

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

have several depressive symptoms
have suicidal ideation.
  • Program-specific intervention knowledge evaluations2 months before baseline

    Post-training L2B, L2B PLUS, and HealthEd knowledge assessments (0-25) will be completed by facilitators with higher scores indicating higher intervention knowledge

  • Number of eligible participants recruited with elevated stress as assessed by the Perceived Stress ScaleWithin a 12-month period

    Study goal of 120 participants total across 4 sites who have elevated stress (\>14) on the Perceived Stress Scale (0-40) where higher scores indicate higher stress

  • Program-specific facilitator adherence ratings of mock intervention group sessions2 months before baseline

    Facilitator adherence to each intervention manual (0-100) for L2B, L2B PLUS, and HealthEd, during mock sessions after intervention facilitation training where higher scores mean higher adherence

  • Program-specific facilitator competence ratings of mock intervention group sessions2 months before baseline

    Facilitator competence of each intervention manual (0-100) for L2B, L2B PLUS, and HealthEd, during mock sessions after intervention facilitation training where higher scores mean higher competence

  • Percentage of eligible students who enrollWithin a 12-month period
  • Percentage of enrolled participants who attend 5/6 intervention sessionsDuring 6-week interventions
  • Acceptability ratings of intervention by participantsWithin one-month of intervention end

    Acceptability ratings (1-5) with higher scores meaning higher acceptability

  • Qualitative assessment of acceptability of interventionsWithin one-month of intervention end

    Focus within group programs will qualitatively assess the acceptability of interventions

  • Percent of participants retained at post-testPost intervention, 6 weeks after baseline
  • Percent retention at six-month follow-up32 weeks after baseline
  • Adherence to standardized data collection protocol measured via standardized checklistsAt baseline, 6 weeks after, and 32 weeks after

    Percentage of data collection protocol adhered to by assessors (0-100) with higher scores indicating better adherence