Mental Health Wellness 1NCT05760443
Mental Health Intervention Research in At-Risk Adolescents
A study testing Learning to BREATHE in people with Mental Health Wellness 1, run by Colorado State University at 1 site in United States.
Trial summary
The goal of the proposed research is to support adolescent health through providing inclusive evidence-based programming that is in line with community needs. Specifically, the investigators aim to: 1) investigate the effects of mindfulness-based intervention (MBI) on adolescent mental health, 2) identify underlying… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Learning to BREATHE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1) between the ages of 12-18 years old,
- 2) Reside in Larimer County or the surrounding area.
Who cannot join
- Adolescents will not take part in the program if they demonstrate active suicidal ideation and/or behavior.
- Adolescents will not take part in the program and/or research activities if they have a medical and/or psychological/behavioral condition that, in the opinion of the research team, could interfere with safety for themselves or others or interfere with the capability of the youth or other participants to potentially benefit from the program (e.g., severe emotional-behavioral disturbance, inability to follow facilitator directions) .
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523
About this study
The goal of the proposed research is to support adolescent health through providing inclusive evidence-based programming that is in line with community needs. Specifically, the investigators aim to: 1) investigate the effects of mindfulness-based intervention (MBI) on adolescent mental health, 2) identify underlying mechanisms (e.g., engagement, stress physiology, emotion regulation) of MBI for adolescent health and wellbeing 3) identify facilitators and barriers of engagement in MBI for community adolescents.
Read the detailed description
Experiencing mental health problems during adolescence is associated with symptom worsening and recurrence later in life, as well as poorer physical health and increased risk for preventable chronic diseases. Mindfulness-based intervention (MBI) has been shown to support key skills and capacities that may protect against mental health challenges, including emotion regulation and stress physiology. Yet, MBI effects on health and wellbeing outcomes in adolescents are generally small and inconsistent across studies. This research will provide an opportunity for testing MBI in community adolescent samples, with a focus on clarifying underlying mechanisms and understanding subjective facilitators and barriers to engagement in MBI is critical.
In research with adolescents, L2B has been associated with improvements in emotion regulation and indicators of mental and physical wellbeing. In our previous work, the investigators delivered L2B as part of a broader healthy lifestyle program for families, and it was feasible and acceptable to adolescent participants. Delivering L2B is also consistent with the results of the 2020 Larimer County Needs Assessment, in which 48% of respondents indicated a need for more resources to support mental health and stress management for youth. Thus, given the solid evidence base for the benefits of L2B for adolescents, our experience delivering L2B to Northern Colorado teens in a previous phase of this community-engaged work, and the identified community need for inclusive, evidence-based mental health prevention programming for adolescents, the investigators will begin delivering L2B and evaluating the program's benefits on adolescent health and wellbeing.
The capacity of mindfulness, or present-centered, nonjudgmental attention, has also been associated with fewer mental health concerns in adolescents. However, meta-analyses and recent large-scale randomized controlled trials indicate that MBI does not always produce the desired outcomes in adolescents. This heterogeneity of findings indicates the need for mechanistic studies that closely examine the processes occurring during and between intervention sessions. This project both addresses an identified community need (inclusive mental health programming for adolescents) and will advance our understanding of the mechanisms that underlie MBI efficacy for supporting youth mental health in nonclinical samples.
This study will be a single-arm trial of an MBI utilizing a repeated measures assessment design. The single-arm nature keeps the project aligned with our goal of meeting community needs, and the multiple assessment timepoints (baseline, weekly across the 6-week intervention, follow-up) allows us to examine temporal ordering of changes in hypothesized mechanisms. With this project the investigators seek to elucidate the underlying mechanisms of mindfulness-based intervention effectiveness for adolescent health.
- Conditions
- Mental Health Wellness 1
- Being tested
- Learning to BREATHE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning to BREATHEBehavioural
Learning 2 BREATHE (L2B) is an empirically-supported, manualized mindfulness-based group program (Broderick, 2021). Participants attend 6 sessions of approximately 1.5 hours per session. "BREATHE" is an acronym: Body, Reflections, Emotions, Attention, Tenderness, Habits, Empowerment; each week's lesson is centered around one of the letters (week 1 encompasses both Body and the overall theme of the sessions, Empowerment). Sample activities of L2B include psycho-education on emotion and self-regulation, body scanning, sitting meditation, non-aerobic yoga, and walking meditation, designed to promote moment-to-moment awareness of mind-body experiences. In between sessions, participants are encouraged to practice brief mindfulness skills in their daily lives and to complete the "homework" assignments, such as an audio-guided body scan. Participants will have access to home-practice audio-recordings and will be queried about their completion of home-practice assignments.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based intervention | Experimental | 6 week group mindfulness-based intervention Receives: Behavioral: Learning to BREATHE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Regulation - Adolescent Report
Adolescent self-report on Difficulties in Emotion Regulation Scale - Short Form; The scale yields a sum score from 0-90 on 18 items. Higher scores indicate more difficulties in emotion regulation
Measured: 6 weeks
Emotion Regulation - Parent Report
Parent self-report on Difficulties in Emotion Regulation Scale - Parent Version; The scale yields a sum score from 0-145 on 29 items. Higher scores indicate more difficulties in emotion regulation
Measured: 6 weeks
Mindfulness - Attention
Adolescent self report on the Mindful Attention Awareness Scale; The scale yields a sum score from 0-75 on 15 items, and then an average will be taken. Higher scores reflect higher levels of dispositional mindfulness.
Measured: 6 weeks
Mindfulness - Self Compassion
Adolescent self report on the Self Compassion Scale - Short Form; The scale yields a sum score from 0-60 on 12 items, and then an average will be taken. Higher scores reflect higher levels of self compassion.
Measured: 6 weeks
Mindfulness - Behavioral Task
Adolescent will complete the Breath Counting Task, a 20-minute computer-administered objective measure of mindfulness. In the task, participants are required to count their breaths in cycles of nine, indicating each breath with a button press. Counting accuracy is calculated as 100% - (# of incorrect ongoing 9-counts + # of self-caught miscounts)/(# of ongoing 9-counts + # of self-caught miscounts).
Measured: 6 weeks
Stress Reactivity - Respiratory Sinus Arrythmia
Respiratory changes will be measured measured by recording the rate and depth of the breathing cycle using a pneumograph transducer fastened around the center of the chest; this transducer measures changes in chest expansion and contraction. This data will be collected throughout a brief baseline period, a stressor task (the Trier Social Stress Task), and a recovery period.
Measured: 6 weeks
Stress Reactivity - Skin Conductance
Skin conductance level will be measured by attaching two electrodes to the participant's fingertips (on the index and middle finger of the left hand). This data will be collected throughout a brief baseline period, a stressor task (the Trier Social Stress Task), and a recovery period.
Measured: 6 weeks
Stress Reactivity - Heart Rate
Electrocardiogram (ECG) will be used to record the electrical signal of the heart using electrodes on both legs above the ankle both and above the right wrist. This will be collected throughout a brief baseline period, a stressor task (the Trier Social Stress Task), and a recovery period.
Measured: 6 weeks
Stress Reactivity - Blood Pressure
A Dinamap Pro will be used to measure systolic and diastolic blood pressure. This will be collected throughout a brief baseline period, a stressor task (the Trier Social Stress Task), and a recovery period.
Measured: 6 weeks
Mental health - Anxiety
Self report on Patient Reported Outcome Measurement Information System Emotional Distress Scale - Anxiety. The scale produces a sum score of 13 to 65 with higher scores indicating greater severity of anxiety.
Measured: 6 weeks
Mental health - Depression
Self report on Patient Reported Outcome Measurement Information System Emotional Distress Scale - Depression. The scale produces a sum score of 14 to 70 with higher scores indicating greater severity of depression.
Measured: 6 weeks
Secondary outcomes (12)
Compassion for others
Self report on Compassion Scale. The scale yields a sum score from 5-80 with higher scores indicating more compassion for others
Measured: 6 weeks
Stress appraisal
Self report on the Perceived Stress Scale. The scale yields sum scores on the PSS from 0 to 40 with higher scores indicating higher perceived stress.
Measured: 6 weeks
Social Media Use
Self report on the Bergen Social Media Addiction Scale. The total score of Bergen Social Media Addiction Scale ranges from 6-30, with higher scores indicating more addictive tendencies in social media use.
Measured: 6 weeks
Eating behavior
Self report on the Reward Based Eating Drive Scale. Items are summed for a total score between 5 and 45, with higher scores indicating more tendency toward reward-based eating.
Measured: 6 weeks
Objectified Body Consciousness
Self report on the Body Surveillance and Body Shame subscales of the Objectified Body Consciousness Scale. Each scale contains 8 items. A sum score between 7 and 112 will be calculated, with higher scores indicating higher body consciousness.
Measured: 6 weeks
Intervention liking and acceptability
Author-developed self report questions. Items will be on a scale of 1 to 5, with higher scores indicating greater liking of the program. Total possible scores will range from 5 to 25.
Measured: 6 week follow up only
Engagement - Cognitive Behavioral
Adolescents will report on the 16-item Activity Engagement Scale. Sum scores are derived, with possible scores from 5 to 80, with higher scores indicating greater engagement.
Measured: 6 weeks
Engagement - Value
Adolescents will complete the 7-item value subscale of the Intrinsic Motivation Inventory. Scores range from 7 to 49, with higher scores indicating more value motivation.
Measured: 6 weeks
Engagement - Interest
Adolescents will complete the 7-item value subscale and the 7-item interest subscale of the Intrinsic Motivation Inventory. Scores range from 7 to 49, with higher scores indicating more interest motivation.
the 8-item Teacher and Classmate Support Scale. They will also report on their home practice of mindfulness and complete the 15-item Applied Mindfulness Process Scale, which assesses the degree to which participants are applying mindfulness as discussed/trained in the intervention sessions. Observational assessments of engagement will be completed by outside raters.
Measured: 6 weeks
Engagement - Teacher and Classmate Support
Adolescents will complete the 8-item Teacher and Classmate Support Scale. A sum score between 5 and 40 is derived, with higher scores indicative of more perceived support.
Measured: 6 weeks
Engagement - Mindfulness
Adolescents will complete the 15-item Applied Mindfulness Process Scale, which assesses the degree to which participants are applying mindfulness as discussed/trained in the program. A sum all 15 items yields score ranging from 0-60, with higher scores indicating more application of mindfulness
Measured: 6 weeks
Engagement - Observational
Independent observers will code videotaped sessions of mindfulness training using the Engagement Observation Protocol. Scores range from 3 to 15, with higher scores indicating more engagement.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start15 May 2023
- Primary completion1 Oct 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Shomaker, Ph.D., Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760443
- Sponsor's protocol ID
- 4219
- Status last verified
- May 2025
- First submitted
- 15 Feb 2023
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Intervention Research in At-Risk Adolescents
- ClinicalTrials.gov ID
- NCT05760443
- Acronym / sponsor ID
- 4219
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 8 Mar 2023 (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 goal of the proposed research is to support adolescent health through providing inclusive evidence-based programming that is in line with community needs. Specifically, the investigators aim to: 1) investigate the effects of mindfulness-based intervention (MBI) on adolescent mental health, 2) identify underlying mechanisms (e.g., engagement, stress physiology, emotion regulation) of MBI for adolescent health and wellbeing 3) identify facilitators and barriers of engagement in MBI for community adolescents.
Detailed description
Experiencing mental health problems during adolescence is associated with symptom worsening and recurrence later in life, as well as poorer physical health and increased risk for preventable chronic diseases. Mindfulness-based intervention (MBI) has been shown to support key skills and capacities that may protect against mental health challenges, including emotion regulation and stress physiology. Yet, MBI effects on health and wellbeing outcomes in adolescents are generally small and inconsistent across studies. This research will provide an opportunity for testing MBI in community adolescent samples, with a focus on clarifying underlying mechanisms and understanding subjective facilitators and barriers to engagement in MBI is critical.
In research with adolescents, L2B has been associated with improvements in emotion regulation and indicators of mental and physical wellbeing. In our previous work, the investigators delivered L2B as part of a broader healthy lifestyle program for families, and it was feasible and acceptable to adolescent participants. Delivering L2B is also consistent with the results of the 2020 Larimer County Needs Assessment, in which 48% of respondents indicated a need for more resources to support mental health and stress management for youth. Thus, given the solid evidence base for the benefits of L2B for adolescents, our experience delivering L2B to Northern Colorado teens in a previous phase of this community-engaged work, and the identified community need for inclusive, evidence-based mental health prevention programming for adolescents, the investigators will begin delivering L2B and evaluating the program's benefits on adolescent health and wellbeing.
The capacity of mindfulness, or present-centered, nonjudgmental attention, has also been associated with fewer mental health concerns in adolescents. However, meta-analyses and recent large-scale randomized controlled trials indicate that MBI does not always produce the desired outcomes in adolescents. This heterogeneity of findings indicates the need for mechanistic studies that closely examine the processes occurring during and between intervention sessions. This project both addresses an identified community need (inclusive mental health programming for adolescents) and will advance our understanding of the mechanisms that underlie MBI efficacy for supporting youth mental health in nonclinical samples.
This study will be a single-arm trial of an MBI utilizing a repeated measures assessment design. The single-arm nature keeps the project aligned with our goal of meeting community needs, and the multiple assessment timepoints (baseline, weekly across the 6-week intervention, follow-up) allows us to examine temporal ordering of changes in hypothesized mechanisms. With this project the investigators seek to elucidate the underlying mechanisms of mindfulness-based intervention effectiveness for adolescent health.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention | Experimental | Behavioral: Learning to BREATHE6 week group mindfulness-based intervention |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 1) between the ages of 12-18 years old,
- 2) Reside in Larimer County or the surrounding area.
Key exclusion criteria (2 listed)
- Adolescents will not take part in the program if they demonstrate active suicidal ideation and/or behavior.
- Adolescents will not take part in the program and/or research activities if they have a medical and/or psychological/behavioral condition that, in the opinion of the research team, could interfere with safety for themselves or others or interfere with the capability of the youth or other participants to potentially benefit from the program (e.g., severe emotional-behavioral disturbance, inability to follow facilitator directions) .
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 BREATHELearning 2 BREATHE (L2B) is an empirically-supported, manualized mindfulness-based group program (Broderick, 2021). Participants attend 6 sessions of approximately 1.5 hours per session. "BREATHE" is an acronym: Body, Reflections, Emotions, Attention, Tenderness, Habits, Empowerment; each week's lesson is centered around one of the letters (week 1 encompasses both Body and the overall theme of the sessions, Empowerment). Sample activities of L2B include psycho-education on emotion and self-regulation, body scanning, sitting meditation, non-aerobic yoga, and walking meditation, designed to promote moment-to-moment awareness of mind-body experiences. In between sessions, participants are encouraged to practice brief mindfulness skills in their daily lives and to complete the "homework" assignments, such as an audio-guided body scan. Participants will have access to home-practice audio-recordings and will be queried about their completion of home-practice assignments. | Behavioural | Mindfulness-based intervention |
Primary outcome
Emotion Regulation - Adolescent Report
Time frame: 6 weeks
Adolescent self-report on Difficulties in Emotion Regulation Scale - Short Form; The scale yields a sum score from 0-90 on 18 items. Higher scores indicate more difficulties in emotion regulation
Emotion Regulation - Parent Report
Time frame: 6 weeks
Parent self-report on Difficulties in Emotion Regulation Scale - Parent Version; The scale yields a sum score from 0-145 on 29 items. Higher scores indicate more difficulties in emotion regulation
Mindfulness - Attention
Time frame: 6 weeks
Adolescent self report on the Mindful Attention Awareness Scale; The scale yields a sum score from 0-75 on 15 items, and then an average will be taken. Higher scores reflect higher levels of dispositional mindfulness.
Mindfulness - Self Compassion
Time frame: 6 weeks
Adolescent self report on the Self Compassion Scale - Short Form; The scale yields a sum score from 0-60 on 12 items, and then an average will be taken. Higher scores reflect higher levels of self compassion.
Mindfulness - Behavioral Task
Time frame: 6 weeks
Adolescent will complete the Breath Counting Task, a 20-minute computer-administered objective measure of mindfulness. In the task, participants are required to count their breaths in cycles of nine, indicating each breath with a button press. Counting accuracy is calculated as 100% - (# of incorrect ongoing 9-counts + # of self-caught miscounts)/(# of ongoing 9-counts + # of self-caught miscounts).
Stress Reactivity - Respiratory Sinus Arrythmia
Time frame: 6 weeks
Respiratory changes will be measured measured by recording the rate and depth of the breathing cycle using a pneumograph transducer fastened around the center of the chest; this transducer measures changes in chest expansion and contraction. This data will be collected throughout a brief baseline period, a stressor task (the Trier Social Stress Task), and a recovery period.
Stress Reactivity - Skin Conductance
Time frame: 6 weeks
Skin conductance level will be measured by attaching two electrodes to the participant's fingertips (on the index and middle finger of the left hand). This data will be collected throughout a brief baseline period, a stressor task (the Trier Social Stress Task), and a recovery period.
Stress Reactivity - Heart Rate
Time frame: 6 weeks
Electrocardiogram (ECG) will be used to record the electrical signal of the heart using electrodes on both legs above the ankle both and above the right wrist. This will be collected throughout a brief baseline period, a stressor task (the Trier Social Stress Task), and a recovery period.
Stress Reactivity - Blood Pressure
Time frame: 6 weeks
A Dinamap Pro will be used to measure systolic and diastolic blood pressure. This will be collected throughout a brief baseline period, a stressor task (the Trier Social Stress Task), and a recovery period.
Mental health - Anxiety
Time frame: 6 weeks
Self report on Patient Reported Outcome Measurement Information System Emotional Distress Scale - Anxiety. The scale produces a sum score of 13 to 65 with higher scores indicating greater severity of anxiety.
Mental health - Depression
Time frame: 6 weeks
Self report on Patient Reported Outcome Measurement Information System Emotional Distress Scale - Depression. The scale produces a sum score of 14 to 70 with higher scores indicating greater severity of depression.
12 secondary outcomes
Compassion for others
Time frame: 6 weeks
Stress appraisal
Time frame: 6 weeks
Social Media Use
Time frame: 6 weeks
Eating behavior
Time frame: 6 weeks
Objectified Body Consciousness
Time frame: 6 weeks
Intervention liking and acceptability
Time frame: 6 week follow up only
Engagement - Cognitive Behavioral
Time frame: 6 weeks
Engagement - Value
Time frame: 6 weeks
Engagement - Interest
Time frame: 6 weeks
Engagement - Teacher and Classmate Support
Time frame: 6 weeks
Engagement - Mindfulness
Time frame: 6 weeks
Engagement - Observational
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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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.
Lauren Shomaker, Ph.D. principal investigator
Colorado State University
1 site 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 in people with Mental Health Wellness 1, run by Colorado State University at 1 site 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 2 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: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Emotion Regulation - Adolescent Report (time frame: 6 weeks). 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 18 May 2025.