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Active, Not Recruiting

NCT Number: NCT07098845

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stress Behavior Mental Health Mindfulness Based Stress Reduction Personal Satisfaction Psychological Well-Being

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Other names: 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.

Other names: Hey-Durham

Primary outcomes

  1. Program-specific intervention knowledge evaluations

    Time frame: 2 months before baseline

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

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

    Time frame: Within a 12-month period

    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

  3. Program-specific facilitator adherence ratings of mock intervention group sessions

    Time frame: 2 months before baseline

    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

  4. Program-specific facilitator competence ratings of mock intervention group sessions

    Time frame: 2 months before baseline

    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

  5. Percentage of eligible students who enroll

    Time frame: Within a 12-month period

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

    Time frame: During 6-week interventions

  7. Acceptability ratings of intervention by participants

    Time frame: Within one-month of intervention end

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

  8. Qualitative assessment of acceptability of interventions

    Time frame: Within one-month of intervention end

    Focus within group programs will qualitatively assess the acceptability of interventions

  9. Percent of participants retained at post-test

    Time frame: Post intervention, 6 weeks after baseline

  10. Percent retention at six-month follow-up

    Time frame: 32 weeks after baseline

  11. Adherence to standardized data collection protocol measured via standardized checklists

    Time frame: At baseline, 6 weeks after, and 32 weeks after

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

Secondary outcomes

  1. Depressive Symptoms

    Time frame: At baseline, 6 weeks after, and 32 weeks after

    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.

  2. Clinical Depression

    Time frame: At baseline, 6 weeks after, and 32 weeks after

    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.

  3. Anxiety

    Time frame: At baseline, 6 weeks after, and 32 weeks after

    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.

  4. Perceived Stress

    Time frame: At baseline, 6 weeks after, and 32 weeks after

    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.

  5. Social Support

    Time frame: At baseline, 6 weeks after, and 32 weeks after

    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.

  6. Meaning in Life

    Time frame: At baseline, 6 weeks after, and 32 weeks after

    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.

  7. Mindful Attention

    Time frame: At baseline, 6 weeks after, and 32 weeks after

    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.

  8. Self Compassion

    Time frame: At baseline, 6 weeks after, and 32 weeks after

    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.

  9. Application of Mindfulness

    Time frame: At baseline, 6 weeks after, and 32 weeks after

    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.

  10. Previous Experience with Mindfulness

    Time frame: At baseline, 6 weeks after, and 32 weeks after

    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.

  11. Previous Experience with Meditation

    Time frame: At baseline, 6 weeks after, and 32 weeks after

    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.

  12. Cortisol stress reactivity

    Time frame: 3 visits; baseline, after 6-week intervention, and at 6-month followup

    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.

  13. Blood pressure reactivity

    Time frame: 3 visits; baseline, after 6-week intervention, and at 6-month followup

    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.

  14. Heart rate reactivity

    Time frame: 3 visits; baseline, after 6-week intervention, and at 6-month followup

    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.

  15. Daily mindful attention

    Time frame: During the 6-week group program

    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.

  16. Daily self-compassion

    Time frame: During the 6-week group program

    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.

  17. Daily home practice of intervention material

    Time frame: During the 6-week group program

    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.

  18. Daily negative events

    Time frame: During the 6-week group program

    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).

  19. Daily psychological distress

    Time frame: During the 6-week group program

    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.

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: 4SITE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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