Mindfulness-Based Intervention for Stress
(4SITE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to find effective ways to reduce depression, anxiety, and stress in college students. It compares two mindfulness programs, Learning to BREATHE and Learning to BREATHE Plus, with a health education program to determine which best helps students manage stress. The trial seeks college students who feel stressed and can attend in-person sessions next semester. Participants need a smartphone to join.
As an unphased trial, this study offers students the opportunity to explore innovative mindfulness techniques to enhance their well-being.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on mindfulness and stress reduction for college students.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the Learning to BREATHE (L2B) program is safe and easy to use. This mindfulness program aims to reduce stress. Studies have found that participants usually feel less stressed after completing the program, with no significant reports of harmful effects.
For Learning to BREATHE Plus (L2B PLUS), which includes a tech component, research also suggests it is safe and well-received. Participants find it easy to use, and there are no major safety concerns. Both programs focus on mindfulness and stress reduction, offering safe options for managing stress and improving mental health.12345Why are researchers excited about this trial?
Researchers are excited about Learning to BREATHE (L2B) and Learning to BREATHE Plus (L2B PLUS) because they offer a fresh approach to managing stress through mindfulness techniques. Unlike standard stress treatments, which often involve medication or traditional talk therapy, these methods focus on teaching mindfulness and emotional regulation, empowering individuals to handle stress more effectively on their own. L2B PLUS goes a step further by incorporating additional elements to enhance these mindfulness practices, potentially offering even greater benefits. This approach is particularly appealing as it promotes self-awareness and personal resilience, which can lead to long-lasting stress management without relying solely on medication.
What evidence suggests that this trial's treatments could be effective for reducing depression, anxiety, and stress?
Research has shown that the Learning to BREATHE (L2B) program, which participants in this trial may receive, helps reduce stress and depression in students. Studies have found that participants experience less depression and feel more satisfied with their lives, with one key result being a 10% drop in self-reported stress levels. Meanwhile, Learning to BREATHE Plus (L2B PLUS), another treatment option in this trial, shows early signs of being practical and well-received, with possible benefits like better mindfulness and emotion control. Both programs use mindfulness techniques to help manage stress and improve overall mental health.56789
Who Is on the Research Team?
Rachel Lucas-Thompson, Dr.
Principal Investigator
Colorado State University
Are You a Good Fit for This Trial?
This trial is for U.S. college students who are struggling with depression, anxiety, and stress but aren't getting enough mental health support. Participants should be interested in trying mindfulness-based interventions or health education programs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants undergo a 6-week intervention with either L2B PLUS, L2B, or HealthEd
Follow-up
Participants are monitored for outcomes such as depression, anxiety, and stress
What Are the Treatments Tested in This Trial?
Interventions
- Learning to BREATHE
- Learning to BREATHE Plus
Find a Clinic Near You
Who Is Running the Clinical Trial?
Colorado State University
Lead Sponsor
University of Colorado, Denver
Collaborator
University of Minnesota
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Macalester College
Collaborator