MindfulnessNCT04927286
Implementing Learning 2 BREATHE in Campus Connections
A study testing Learning to Breathe and Campus Connections in people with Mindfulness, run by Colorado State University at 1 site in United States.
Trial summary
The overall objective of this study is to investigate a mindfulness-based intervention's feasibility/acceptability and effectiveness for improving eating behaviors and depression symptoms among adolescents (9-18y; 63% living on low-income), referred to a community-based mentoring program for being "at-risk for not… Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness
- What is being tested?
- Learning to Breathe and Campus Connections
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 29 Jun 2022
- 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 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Mentees (adolescents) participating in campus connections who are 9-18y and English speaking
Who cannot join
- Mentees (adolescents) that are not participating in campus connections
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State Univeristy
Fort Collins, Colorado, 80526
About this study
The overall objective of this study is to investigate a mindfulness-based intervention's feasibility/acceptability and effectiveness for improving eating behaviors and depression symptoms among adolescents (9-18y; 63% living on low-income), referred to a community-based mentoring program for being "at-risk for not reaching their full potential" (e.g., Department of Human Services involvement, behavioral/emotion problems). As a part of this study, we will also characterize the real-time relationships among life stressors, untrained state mindfulness, and emotion regulation difficulties in adolescents' daily lives and determine to what extent an MBI helps adolescents to maintain mindfulness and emotion regulation in moments when they experience a stressor.
- Conditions
- Mindfulness
- Being tested
- Learning to Breathe, Campus Connections
- Keywords
- adolescents, mindfulness, ecological momentary assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning to BreatheBehavioural
Learning to Breathe is an evidence-based mindfulness curriculum for adolescents
Campus ConnectionsBehavioural
Campus Connections is a mentoring program for at-risk adolescents
| Study group | Role | What they receive |
|---|---|---|
| Mentoring+Mindfulness | Experimental | Not described Receives: Behavioral: Learning to Breathe |
| Mentoring as usual | Active comparator | Not described Receives: Behavioral: Campus Connections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reward-based Eating Behaviors
Changes in Reward-based eating behaviors for all participants will be assessed with the Reward-based eating behaviors scale (Mason et al., 2017)
Measured: Through study completion, an average of 6 months
Internalizing and Externalizing Symptoms
The Brief problem monitor (Achenbach et al., 2011) will be used to assess for changes in internalizing (e.g., depression symptoms) and externalizing symptoms for all participants.
Measured: Through study completion, an average of 6 months
Mindfulness
The mindfulness attention and awareness scale (Brown \& Ryan, 2003) will be used to assess for changes in mindfulness for all participants
Measured: Through study completion, an average of 6 months
Emotion Regulation
The Difficulties in Emotion Regulation Scale-Short Form (Kaufman et al., 2016) will be used to assess for changes in difficulties with emotion regulation for all participants
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start14 Jun 2021
- Primary completion29 Jun 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MindfulnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927286
- Sponsor's protocol ID
- 2008
- Status last verified
- Sep 2022
- First submitted
- 3 Jun 2021
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miller-Chagnon RL, Shomaker LB, Prince MA, Krause JT, Rzonca A, Haddock SA, Zimmerman TS, Lavender JM, Sibinga E, Lucas-Thompson RG. The benefits of mindfulness training for momentary mindfulness and emotion regulation: A randomized controlled trial for adolescents exposed to chronic stressors. J Consult Clin Psychol. 2024 Dec;92(12):800-813. doi: 10.1037/ccp0000910.
PubMed 39715423Miller RL, Shomaker LB, Prince MA, Haddock S, Rzonca A, Krause JT, Zimmerman T, Lavender JM, Sibinga E, Lucas-Thompson RG. Momentary effects of life stressors on mindfulness and emotion regulation difficulties among adolescents exposed to chronic stressors. Stress Health. 2024 Oct;40(5):e3414. doi: 10.1002/smi.3414. Epub 2024 Apr 29.
PubMed 38685855
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Learning 2 BREATHE in Campus Connections
- ClinicalTrials.gov ID
- NCT04927286
- Acronym / sponsor ID
- 2008
- Conditions
- Mindfulness
- Keywords
- adolescents, mindfulness, ecological momentary assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 15 Jun 2021 (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 overall objective of this study is to investigate a mindfulness-based intervention's feasibility/acceptability and effectiveness for improving eating behaviors and depression symptoms among adolescents (9-18y; 63% living on low-income), referred to a community-based mentoring program for being "at-risk for not reaching their full potential" (e.g., Department of Human Services involvement, behavioral/emotion problems). As a part of this study, we will also characterize the real-time relationships among life stressors, untrained state mindfulness, and emotion regulation difficulties in adolescents' daily lives and determine to what extent an MBI helps adolescents to maintain mindfulness and emotion regulation in moments when they experience a stressor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentoring+Mindfulness | Experimental | Behavioral: Learning to Breathe |
| Mentoring as usual | Active comparator | Behavioral: Campus Connections |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Mentees (adolescents) participating in campus connections who are 9-18y and English speaking
Key exclusion criteria (1 listed)
- Mentees (adolescents) that are not participating in campus connections
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 to Breathe is an evidence-based mindfulness curriculum for adolescents | Behavioural | Mentoring+Mindfulness |
| Campus ConnectionsCampus Connections is a mentoring program for at-risk adolescents | Behavioural | Mentoring as usual |
Primary outcome
Reward-based Eating Behaviors
Time frame: Through study completion, an average of 6 months
Changes in Reward-based eating behaviors for all participants will be assessed with the Reward-based eating behaviors scale (Mason et al., 2017)
Internalizing and Externalizing Symptoms
Time frame: Through study completion, an average of 6 months
The Brief problem monitor (Achenbach et al., 2011) will be used to assess for changes in internalizing (e.g., depression symptoms) and externalizing symptoms for all participants.
Mindfulness
Time frame: Through study completion, an average of 6 months
The mindfulness attention and awareness scale (Brown \& Ryan, 2003) will be used to assess for changes in mindfulness for all participants
Emotion Regulation
Time frame: Through study completion, an average of 6 months
The Difficulties in Emotion Regulation Scale-Short Form (Kaufman et al., 2016) will be used to assess for changes in difficulties with emotion regulation for all participants
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 26 Sep 2022.
- Derived from this study: PubMed 39715423Miller-Chagnon RL, Shomaker LB, Prince MA, Krause JT, Rzonca A, Haddock SA, Zimmerman TS, Lavender JM, Sibinga E, Lucas-Thompson RG. The benefits of mindfulness training for momentary mindfulness and emotion regulation: A randomized controlled trial for adolescents exposed to chronic stressors. J Consult Clin Psychol. 2024 Dec;92(12):800-813. doi: 10.1037/ccp0000910.
- Derived from this study: PubMed 38685855Miller RL, Shomaker LB, Prince MA, Haddock S, Rzonca A, Krause JT, Zimmerman T, Lavender JM, Sibinga E, Lucas-Thompson RG. Momentary effects of life stressors on mindfulness and emotion regulation difficulties among adolescents exposed to chronic stressors. Stress Health. 2024 Oct;40(5):e3414. doi: 10.1002/smi.3414. Epub 2024 Apr 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Campus Connections in people with Mindfulness, 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 1 inclusion and 1 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 26 Sep 2022. 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?
Reward-based Eating Behaviors (time frame: Through study completion, an average of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04927286, which also lists 2 linked publications.
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 26 Sep 2022; AzTrials last refreshed its copy on 28 Oct 2026.