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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress; Mental Health; Mindfulness Based Stress Reduction
• Intervention / Treatment: Behavioral: Learning to BREATHE; Behavioral: Learning to BREATHE Plus; Behavioral: HealthEd

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • University of Colorado Denver
    • Fort Collins, Colorado, United States, 80523
      • Colorado State University
  • Minnesota
    • Saint Paul, Minnesota, United States, 55108
      • University of Minnesota
    • Saint Paul, Minnesota, United States, 55105
      • Macalester College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Learning to BREATHE (L2B)	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.; Other Names: L2B
Experimental: Learning to BREATHE Plus (L2B PLUS)	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.; Other Names: L2B PLUS
Active Comparator: HealthEd	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.; Other Names: Hey-Durham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	Participant depressive symptoms will be assessed using the Center for Epidemiological Studies Depression Scale (Radloff, 1977). The Center for Epidemiological Studies Depression Scale has 20 questions rated on a 1-4 Likert scale where higher scores indicate higher depressive symptoms.	At baseline, 6 weeks after, and 32 weeks after
Clinical Depression	Participant levels of clinical depression will be assessed using the Beck Depression Inventory (Beck et al., 1961). The Beck Depression Inventory has 21 questions rated on a 0-3 Likert scale where higher scores indicate higher depressive symptoms.	At baseline, 6 weeks after, and 32 weeks after
Anxiety	Participant anxiety will be assessed using the State-Trait Anxiety Inventory (Beiling et al., 1998). It has 20 questions rated on a 1-4 Likert scale where higher scores indicate higher anxiety.	At baseline, 6 weeks after, and 32 weeks after
Perceived Stress	Participant perceived stress will be assessed using the Perceived Stress Scale (Cohen et al., 1983). It has 14 questions rated on a 0-4 Likert scale where higher scores indicate higher perceived stress.	At baseline, 6 weeks after, and 32 weeks after
Social Support	Participant social support will be assessed using the Multidimensional Scale of Percevied Social Support (Zimet et al., 1988). It has 12 questions rated on a 1-7 Likert scale where higher scores indicate higher social support.	At baseline, 6 weeks after, and 32 weeks after
Meaning in Life	Participant meaning in life will be assessed using the Meaning in Life Questionaire (Steger et al., 2006). It has 10 questions rated on a 1-7 Likert scale where higher scores indicate higher meaning in life.	At baseline, 6 weeks after, and 32 weeks after
Mindful Attention	Participant mindful attention will be assessed using the Mindful Attention and Awareness Scale (Brown et al., 2011). It has 14 questions rated on a 1-6 Likert scale where higher scores indicate higher mindful attention.	At baseline, 6 weeks after, and 32 weeks after
Self Compassion	Participant self compassion will be assessed using the Self Compassion Scale Short Form Attention (Raes et al., 2011). It has 12 questions rated on a 1-5 Likert scale where higher scores indicate higher self compassion.	At baseline, 6 weeks after, and 32 weeks after
Application of Mindfulness	Participant application of mindfulness will be assessed using the Applied Mindfulness Process Scale (Roemer & Medvedev, 2022). It has 15 questions rated on a 1-5 Likert scale where higher scores indicate higher mindfulness application.	At baseline, 6 weeks after, and 32 weeks after
Previous Experience with Mindfulness	Participant previous experience with mindfulness will be assessed using the mindfulness experience and knowledge questionnaire (Qian Lau & Olivia, 2023). The mindfulness experience and knowledge questionnaire has 1 question rated on a 1-5 scale where higher scores indicate more previous mindfulness experiences.	At baseline, 6 weeks after, and 32 weeks after
Previous Experience with Meditation	Participant previous experience with mindfulness will be assessed using a meditation questionnaire (Russell et al., 2018). The meditation questionnaire has 3 questions rated on a 1-3 Likert scale where higher scores mean more meditation knowledge.	At baseline, 6 weeks after, and 32 weeks after
Cortisol stress reactivity	Cortisol reactivity to a stressor will be assessed via saliva samples collected before stressor as a test, before stressor as a baseline, immediately after stressor, and 10 minutes and 20minutes after stressor. Area under the curve will be calculated.	3 visits; baseline, after 6-week intervention, and at 6-month followup
Blood pressure reactivity	To assess blood pressure reactivity to a stressor, participant blood pressure will be measured at three minutes intervals across baseline and during the stressor. Change from baseline to stressor will be calculated.	3 visits; baseline, after 6-week intervention, and at 6-month followup
Heart rate reactivity	To assess cardiovascular reactivity to a stressor, participant heart rate will be measured at three minutes intervals across baseline and during the stressor. Change from baseline to stressor will be calculated.	3 visits; baseline, after 6-week intervention, and at 6-month followup
Daily mindful attention	On a 5 question scale, with answer choices ranging from 1-6 (Brown & West, 2003), participants will report on their mindfulness each day during the group program. Higher scores indicate greater mindlessness.	During the 6-week group program
Daily self-compassion	Participants will report their self-compassion each day during the group program using two questions (answer choices: 1 not at all to 10 extremely), with high scores indicating greater self-compassion.	During the 6-week group program
Daily home practice of intervention material	Each day during the group program, participants will be asked to describe the extent to which the formally (1 question) and informally (1 question) engaged with what they learned in their group program (Bijkerk et al., 2023). Higher scores indicate greater engagement.	During the 6-week group program
Daily negative events	Participants will list up to 5 negative events that occurred each day and, for each, rate their severity (from 0=not at all severe to 5=extremely severe) (Hankin et al., 2005).	During the 6-week group program
Daily psychological distress	Each day, participants will be asked to report their psychological distress using the short-form (4 item) of the perceived stress scale (Cohen et al., 1983). Answer choices range from 1=never to 5=very often; higher scores indicate greater distress.	During the 6-week group program

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: University of Colorado, Denver; National Center for Complementary and Integrative Health (NCCIH); University of Minnesota; Macalester College
• Investigators: Principal Investigator: Rachel Lucas-Thompson, Dr., Colorado State University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 10, 2025
• First Submitted That Met QC Criteria: July 25, 2025
• First Posted (Actual): August 1, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; Stress; Mindfulness; College Students
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: 5036; 1R01AT012652 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Researchers interested in using these data to test novel hypotheses can contact the corresponding author and submit a data proposal form to be reviewed by the study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No