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

NANot yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

May 31, 2026

Study Completion Date

December 31, 2026

Conditions
StressMental HealthMindfulness Based Stress Reduction
Interventions
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.

Trial Locations (4)

55105

Macalester College, Saint Paul

55108

University of Minnesota, Saint Paul

80204

University of Colorado Denver, Denver

80523

Colorado State University, Fort Collins

All Listed Sponsors
collaborator

University of Minnesota

OTHER

collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

collaborator

University of Colorado, Denver

OTHER

collaborator

Macalester College

UNKNOWN

lead

Colorado State University

OTHER

NCT07098845 - Mindfulness-Based Intervention With a Supplement for Stress-Related Problems in College Students Across Multiple Sites (4SITE) | Biotech Hunter | Biotech Hunter