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

NCT07098845 | Recruiting DMC

• 2 other identifiers: 50361R01AT012652
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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.

Conditions

Stress; Mental Health; Mindfulness Based Stress Reduction

Keywords

Mindfulness; Stress; College Students; Mental Health

Outcome Measures

Primary Outcomes (11)

• Program-specific intervention knowledge evaluations

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

  2 months before baseline

• Number of eligible participants recruited with elevated stress as assessed by the Perceived Stress Scale

  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

  Within a 12-month period

• Program-specific facilitator adherence ratings of mock intervention group sessions

  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

  2 months before baseline

• Program-specific facilitator competence ratings of mock intervention group sessions

  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

  2 months before baseline

• Percentage of eligible students who enroll

  Within a 12-month period

• Percentage of enrolled participants who attend 5/6 intervention sessions

  During 6-week interventions

• Acceptability ratings of intervention by participants

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

  Within one-month of intervention end

• Qualitative assessment of acceptability of interventions

  Focus within group programs will qualitatively assess the acceptability of interventions

  Within one-month of intervention end

• Percent of participants retained at post-test

  Post intervention, 6 weeks after baseline

• Percent retention at six-month follow-up

  32 weeks after baseline

• Adherence to standardized data collection protocol measured via standardized checklists

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

  At baseline, 6 weeks after, and 32 weeks after

Secondary Outcomes (19)

• Depressive Symptoms

  At baseline, 6 weeks after, and 32 weeks after

• Clinical Depression

  At baseline, 6 weeks after, and 32 weeks after

• Anxiety

  At baseline, 6 weeks after, and 32 weeks after

• Perceived Stress

  At baseline, 6 weeks after, and 32 weeks after

• Social Support

  At baseline, 6 weeks after, and 32 weeks after

Study Arms (3)

Learning to BREATHE (L2B)

ACTIVE COMPARATOR

Behavioral: Learning to BREATHE

Learning to BREATHE Plus (L2B PLUS)

EXPERIMENTAL

Behavioral: Learning to BREATHE Plus

HealthEd

ACTIVE COMPARATOR

Behavioral: HealthEd

Interventions

Learning to BREATHE 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.

Also known as: L2B

Learning to BREATHE (L2B)

Learning to BREATHE Plus 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.

Also known as: L2B PLUS

Learning to BREATHE Plus (L2B PLUS)

HealthEd 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.

Also known as: Hey-Durham

HealthEd

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• have several depressive symptoms
• have suicidal ideation.

Sponsors & Collaborators

• Colorado State University: lead
• University of Minnesota: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Colorado, Denver: collaborator
• Macalester College: collaborator

Study Sites (4)

University of Colorado Denver

Denver, Colorado, 80204, United States

RECRUITING

Colorado State University

Fort Collins, Colorado, 80523, United States

RECRUITING

Macalester College

Saint Paul, Minnesota, 55105, United States

RECRUITING

University of Minnesota

Saint Paul, Minnesota, 55108, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Rachel Lucas-Thompson, Dr.

  Colorado State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Lucas-Thompson, PhD

CONTACT

970-491-5718; lucas-thompson.rachel.graham@colostate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Human Development & Family Studies and Colorado School of Public Health

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: August 1, 2025
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)