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

NCT ID: NCT07098845

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Learning to BREATHE (L2B)

Group Type: ACTIVE_COMPARATOR

Learning to BREATHE

Intervention Type: BEHAVIORAL

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.

Learning to BREATHE Plus (L2B PLUS)

Group Type: EXPERIMENTAL

Learning to BREATHE Plus

Intervention Type: BEHAVIORAL

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.

HealthEd

Group Type: ACTIVE_COMPARATOR

HealthEd

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

L2B; L2B PLUS; Hey-Durham

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• have several depressive symptoms
• have suicidal ideation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Macalester College

UNKNOWN

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Rachel Graham

Professor of Human Development & Family Studies and Colorado School of Public Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Lucas-Thompson, Dr.

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

University of Colorado Denver

Denver, Colorado, United States

Site Status: RECRUITING

Colorado State University

Fort Collins, Colorado, United States

Site Status: RECRUITING

Macalester College

Saint Paul, Minnesota, United States

Site Status: RECRUITING

University of Minnesota

Saint Paul, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Lucas-Thompson, PhD

Role: CONTACT

lucas-thompson.rachel.graham@colostate.edu

970-491-5718

Facility Contacts

Charlotte Farewell, PhD

Role: primary

charlotte.farewell@cuanshutz.edu

609-937-4241

Rachel Lucas-Thompson, PhD

Role: primary

lucas-thompson.rachel.graham@colostate.edu

970-491-5718

Brian Rood, PhD

Role: primary

Timothy Piehler, PhD

Role: primary

tpiehler@umn.com

(612) 301-1484

Other Identifiers

5036

Identifier Type: -

Identifier Source: org_study_id

1R01AT012652

Identifier Type: NIH

Identifier Source: secondary_id

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