NCT07098845

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

Testing a Mindfulness-Based Intervention With a Multi-Modal Adaptive Supplement for Stress-Related Problems in College Students

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Colorado State University · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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.

Detailed description

There have been dramatic and concerning increases in rates of psychological distress in students enrolled in US colleges and universities over the last decade. The majority of college students in the last year experienced mental health problems, and if left untreated, symptoms of these problems have serious individual and public health consequences, both in the short- and long-term. However the vast majority of students do not receive professional mental health support because traditional treatments are perceived as ineffective and inconvenient. Additionally, many on campus resources cannot meet the demand of students needing support. As a result, it is critical to identify acceptable and effective interventions to address what is being called a "campus mental health crisis." Mindfulness-based interventions (MBIs) are very well-liked by college students, most of whom are late adolescents; in addition they are effective at increasing mindfulness and emotion regulation as well as reducing stress and depression. However, MBI effects have typically been small-to-moderate. Outside of the mindfulness literature, technological supplements to group-based programs like MBIs have been found to be effective at increasing intervention efficacy. The investigative team developed the first multi-modal adaptive supplement to an MBI (5K01AT009592), Learning To BREATHE PLUS ( L2B PLUS), which supplements an evidence-based group MBI with multiple methods of support for practicing mindfulness in daily life. The investigators program of research provides evidence at a single site that L2P PLUS is feasible and highly acceptable to adolescents, results in sustained levels of engagement across the group program period, and appears to be more effective than the standard Learning To BREATHE group program (L2B) at increasing daily mindfulness practice and consistency of mindfulness during stress as well as reducing psychological distress. In turn, L2B appears more effective in reducing stress-related behavior compared to an active, didactic health education control (HealthEd). Building directly on the investigators' prior work the proposed R01 study is a multisite, pilot randomized controlled trial implemented at four sites in order to prepare for a future multi-site efficacy trial testing the effects of L2B PLUS relative to the standard L2B program and HealthEd on depression, anxiety, and stress. Specific aims of the current proposal are to: 1) evaluate multi-site fidelity of training and implementation of 6-week L2B PLUS, 6 week L2B and 6-week HealthEd to college students experiencing stress, 2) test multi-site feasibility and acceptability of recruitment, retention, and protocol adherence for randomized control trial (RCT) involving L2B PLUS, L2B, and HealthEd, and 3) modify training/implementation and protocol for a future, fully powered multi-site efficacy trial. Completion of these aims will prepare us for an adequately-powered, multi-site efficacy trial, and ultimately inform a complementary and integrative approach to supporting college students experiencing problems with stress.

Conditions

• Stress
• Mental Health
• Mindfulness Based Stress Reduction

Interventions

Type	Name	Description
BEHAVIORAL	Learning to BREATHE	L2B is a group MBI designed for adolescents (Broderick \& Metz, 2009) and teaches three families of practices: focused attention (e.g., breath awareness), open awareness (i.e., awareness of sensations, thoughts, and feelings as they occur), and compassion. Each letter in BREATHE corresponds to a theme: Body, Reflections, Emotions, Attention, Tenderness, and Habits, building to the overall goal of Empowerment. Each session involves guided discussions, activities, and mindfulness practices.
BEHAVIORAL	Learning to BREATHE Plus	The in-person, group program portion of L2B PLUS and L2B are identical. But, L2B PLUS (Lucas-Thompson et al., 2020) builds on the standard L2B program with 3 additional supplements: 1) Extensive on-demand library designed by the team to be integrated with the group program and specifically to allow participants to independently practice skills that have already been introduced in the group program. 2) Intervention messages sent across the day. The team developed intervention messages to be sent 5 times a day to participants (Lucas-Thompson et al., 2020). Each week, participants receive intervention content tailored to what they have just learned in the group program. 3) JIT support. When participants indicate high stress via EMAs completed during the intervention period, tailored intervention content is delivered "just-in-time" during a moment of high need. These JIT messages were developed specifically to support applying or using mindfulness during periods of high stress.
BEHAVIORAL	HealthEd	Hey-Durham is a health education program that the team has extensive experience implementing (Lucas-Thompson et al., 2019; Shomaker, Berman, et al., 2019; Shomaker et al., 2016; Tanofsky-Kraff et al., 2014) and covers topics such as domestic violence, substance use, depression/signs of suicide, and conflict resolution. Mental health components focus only on prevalence and identification. There is no content overlap with L2B, but it is matched to L2B in format, time, frequency, in-person contact, and facilitator expertise. Inclusion of HealthEd in a future efficacy trial will allow us to test the extent to which the active ingredients of MBI (i.e,. a top-down and bottom-up focus on emotion and stress regulation(Zelazo \& Carlson, 2012)), with and without the between-session support L2B, improve mental health and stress responding, relative to an active control matched for critical characteristics but that does not include these active ingredients.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2025-08-01
• Last updated: 2025-11-14

Locations

4 sites across 1 country: United States