Stress4SITENCT07098845
Mindfulness-Based Intervention With a Supplement for Stress-Related Problems in College Students Across Multiple Sites (4SITE)
A study testing Learning to BREATHE, Learning to BREATHE Plus and HealthEd in people with Stress and Mental Health, run by Colorado State University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Mental Health, Mindfulness Based Stress Reduction
- What is being tested?
- Learning to BREATHE, Learning to BREATHE Plus and HealthEd
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- have several depressive symptoms
- have suicidal ideation.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado Denver
Denver, Colorado, 80204
Colorado State University
Fort Collins, Colorado, 80523
Macalester College
Saint Paul, Minnesota, 55105
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
Official title: 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.
Read the 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
- Being tested
- Learning to BREATHE, Learning to BREATHE Plus, HealthEd
- Keywords
- Mindfulness, Stress, College Students, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning to BREATHEBehavioural
Also called L2B
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 PlusBehavioural
Also called L2B 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.
HealthEdBehavioural
Also called Hey-Durham
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.
| Study group | Role | What they receive |
|---|---|---|
| Learning to BREATHE (L2B) | Active comparator | Not described Receives: Behavioral: Learning to BREATHE |
| Learning to BREATHE Plus (L2B PLUS) | Experimental | Not described Receives: Behavioral: Learning to BREATHE Plus |
| HealthEd | Active comparator | Not described Receives: Behavioral: HealthEd |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 months before baseline
Percentage of eligible students who enroll
Measured: Within a 12-month period
Percentage of enrolled participants who attend 5/6 intervention sessions
Measured: During 6-week interventions
Acceptability ratings of intervention by participants
Acceptability ratings (1-5) with higher scores meaning higher acceptability
Measured: Within one-month of intervention end
Qualitative assessment of acceptability of interventions
Focus within group programs will qualitatively assess the acceptability of interventions
Measured: Within one-month of intervention end
Percent of participants retained at post-test
Measured: Post intervention, 6 weeks after baseline
Percent retention at six-month follow-up
Measured: 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
Measured: At baseline, 6 weeks after, and 32 weeks after
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: During the 6-week group program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Oct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, National Center for Complementary and Integrative Health (NCCIH), University of Colorado, Denver, Macalester College
- Responsible party
- Principal investigator, Rachel Graham, Colorado State University
- Investigators
- Rachel Lucas-Thompson, Dr., Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098845
- Sponsor's protocol ID
- 5036
- Other IDs
- 1R01AT012652
- Acronym
- 4SITE
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Mindfulness-Based Intervention With a Multi-Modal Adaptive Supplement for Stress-Related Problems in College Students
- ClinicalTrials.gov ID
- NCT07098845
- Acronym / sponsor ID
- 4SITE / 5036
- Conditions
- Stress, Mental Health, Mindfulness Based Stress Reduction
- Keywords
- Mindfulness, Stress, College Students, Mental Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- University of Minnesota, National Center for Complementary and Integrative Health (NCCIH), University of Colorado, Denver, Macalester College
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- have several depressive symptoms
- have suicidal ideation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learning to BREATHEAlso: L2BL2B 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. | Behavioural | Learning to BREATHE (L2B) |
| Learning to BREATHE PlusAlso: L2B PLUSThe 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. | Behavioural | Learning to BREATHE Plus (L2B PLUS) |
| HealthEdAlso: Hey-DurhamHey-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. | Behavioural | HealthEd |
Primary outcome
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
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
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
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
Percentage of eligible students who enroll
Time frame: Within a 12-month period
Percentage of enrolled participants who attend 5/6 intervention sessions
Time frame: During 6-week interventions
Acceptability ratings of intervention by participants
Time frame: Within one-month of intervention end
Acceptability ratings (1-5) with higher scores meaning higher acceptability
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
Percent of participants retained at post-test
Time frame: Post intervention, 6 weeks after baseline
Percent retention at six-month follow-up
Time frame: 32 weeks after baseline
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
19 secondary outcomes
Depressive Symptoms
Time frame: At baseline, 6 weeks after, and 32 weeks after
Clinical Depression
Time frame: At baseline, 6 weeks after, and 32 weeks after
Anxiety
Time frame: At baseline, 6 weeks after, and 32 weeks after
Perceived Stress
Time frame: At baseline, 6 weeks after, and 32 weeks after
Social Support
Time frame: At baseline, 6 weeks after, and 32 weeks after
Meaning in Life
Time frame: At baseline, 6 weeks after, and 32 weeks after
Mindful Attention
Time frame: At baseline, 6 weeks after, and 32 weeks after
Self Compassion
Time frame: At baseline, 6 weeks after, and 32 weeks after
Application of Mindfulness
Time frame: At baseline, 6 weeks after, and 32 weeks after
Previous Experience with Mindfulness
Time frame: At baseline, 6 weeks after, and 32 weeks after
Previous Experience with Meditation
Time frame: At baseline, 6 weeks after, and 32 weeks after
Cortisol stress reactivity
Time frame: 3 visits; baseline, after 6-week intervention, and at 6-month followup
Blood pressure reactivity
Time frame: 3 visits; baseline, after 6-week intervention, and at 6-month followup
Heart rate reactivity
Time frame: 3 visits; baseline, after 6-week intervention, and at 6-month followup
Daily mindful attention
Time frame: During the 6-week group program
Daily self-compassion
Time frame: During the 6-week group program
Daily home practice of intervention material
Time frame: During the 6-week group program
Daily negative events
Time frame: During the 6-week group program
Daily psychological distress
Time frame: During the 6-week group program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Lucas-Thompson, Dr. principal investigator
Colorado State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning to BREATHE, Learning to BREATHE Plus and HealthEd in people with Stress and Mental Health, run by Colorado State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program-specific intervention knowledge evaluations (time frame: 2 months before baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.