Mindfulness-Based Intervention for Adolescent Mental Health

Overseen By Megan Moran, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Colorado State University

Disqualifiers: Suicidal ideation, Severe disturbance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a mindfulness-based program, Learning to BREATHE, can improve mental health in teenagers. Researchers seek to understand the effects of mindfulness on stress, emotions, and overall well-being. They also examine factors influencing teens' decisions to join or avoid these programs. Teens aged 12 to 18 living in Larimer County without severe emotional or behavioral issues may be suitable candidates for this trial. As an unphased trial, this study offers teens a unique opportunity to contribute to research that could enhance mental health programs for their peers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the research team.

What prior data suggests that this mindfulness-based intervention is safe for adolescents?

Research has shown that mindfulness programs, such as Learning to BREATHE, are generally safe for teenagers. Studies have found these programs can improve mental health by reducing symptoms of depression and anxiety. Most reports indicate that participants handle these programs well, with no major negative effects. Thus, joining such programs could be a safe way to support teens' mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Learning to BREATHE program because it offers a fresh approach to improving adolescent mental health through mindfulness. Unlike traditional treatments such as medication or cognitive behavioral therapy, this intervention focuses on teaching young people mindfulness skills over a six-week group program. This method helps adolescents develop self-awareness and stress management techniques, potentially reducing symptoms of anxiety and depression without relying on medication. The emphasis on mindfulness provides a holistic approach that empowers teens to manage their mental health more proactively.

What evidence suggests that this mindfulness-based intervention is effective for adolescent mental health?

Research shows that the Learning to BREATHE (L2B) program, which participants in this trial will receive, can improve mental health in teenagers. Studies have found that students who participated in L2B felt more satisfied with their lives and showed fewer signs of depression. The program also helps teens manage their emotions better. Mindfulness-based programs like L2B have been shown to boost overall well-being and mental health in young people. These findings suggest that L2B could be a useful tool for supporting teen mental health. ^{2 6 7 8 9}

Who Is on the Research Team?

Lauren Shomaker, Ph.D.

Principal Investigator

Colorado State University

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-18 living near Larimer County who are interested in improving their mental health. Those with severe emotional-behavioral issues, an inability to follow directions, or active suicidal thoughts or behaviors cannot participate.

Inclusion Criteria

Reside in Larimer County or the surrounding area

Exclusion Criteria

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)

I do not have thoughts or behaviors of harming myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week mindfulness-based intervention (MBI) to support adolescent mental health and identify underlying mechanisms.

6 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in mental health and engagement post-intervention.

6 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Learning to BREATHE

Trial Overview

The study tests a mindfulness-based intervention called 'Learning to BREATHE' to see how it affects adolescent mental health and identifies what makes the program effective or challenging for teens.

How Is the Trial Designed?

Group I: Mindfulness-based intervention Experimental Treatment 1 Intervention

6 week group mindfulness-based intervention

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

Published Research Related to This Trial

Mindfulness-based interventions (MBIs) significantly improved symptoms of stress in adolescents, with a small overall effect size of 0.33 based on a meta-analysis of 9 studies involving 5046 participants.

However, MBIs did not show significant effects on depression or anxiety symptoms, particularly when compared to active control groups, indicating that while they may help with stress, their efficacy for other mental health issues is less clear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Meta-analysis on mindfulness-based interventions for adolescents' stress, depression, and anxiety in school settings: a cautionary tale. Fulambarkar, N., Seo, B., Testerman, A., et al.[2023]

Mindfulness-based interventions (MBIs) are increasingly being integrated into cognitive-behavioral therapy for children and adolescents, but research on their specific implementation in individual therapy is still limited.

The 'Mindfulness and Relaxation Study - Children and Adolescents' (MARS-CA) is examining the effects of mindfulness and relaxation interventions on young patients' symptoms and therapeutic relationships, with preliminary results indicating that both types of interventions are effective with juvenile patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness in Trainee Psychotherapies with Children and Adolescents]. Kalmar, J., Engel, S., Baumann, I., et al.[2020]

Mindfulness-based interventions (MBI) show promising effects on psychological health in children and adolescents, particularly in reducing stress, anxiety, and depression, as well as improving executive functions and socio-emotional skills.

Despite the encouraging results, there is a strong need for more rigorously designed studies to validate the efficacy of MBI before implementing these programs widely in school and clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness based interventions for children and adolescents]. Hà-Vinh Leuchter, R., Siffredi, V., Magnus Smith, M., et al.[2020]

This study is testing the effectiveness of an 8-week mindfulness-based intervention (MBI) for adolescents with chronic health conditions, comparing in-person delivery to eHealth delivery, with a focus on improving mindfulness skills, mood, anxiety, self-esteem, and stress levels.

The research aims to show that both delivery methods will be equally effective and feasible, potentially increasing access to MBIs for teens with mobility issues or those living in areas without in-person programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Person Versus eHealth Mindfulness-Based Intervention for Adolescents With Chronic Illness: Protocol for a Randomized Controlled Trial. Chadi, N., Kaufman, M., Weisbaum, E., et al.[2020]

A 5-week mindfulness-based intervention for adolescents with psychiatric disorders led to significant decreases in psychological distress and increases in mindfulness and self-esteem, indicating its potential effectiveness.

Both adolescents and their parents reported improvements in functioning, suggesting that the intervention is not only feasible and acceptable but also beneficial for mental health, warranting further research in a randomized controlled study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taming the adolescent mind: preliminary report of a mindfulness-based psychological intervention for adolescents with clinical heterogeneous mental health diagnoses. Tan, L., Martin, G.[2022]

This review aims to synthesize existing literature on mindfulness-based interventions (MBIs) for children and adolescents, highlighting their application for both healthy individuals and those with various disorders, which is still a developing field.

The study will provide a comprehensive overview of MBI methodologies and outcomes, helping to identify trends and gaps in research, ultimately guiding future studies to enhance the effectiveness of mindfulness practices in pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for children and adolescents across all settings: a scoping review protocol. Perrier, MF., Gurgel-Juarez, N., Flowers, HL., et al.[2021]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

Citations

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researchgate.net

researchgate.net/publication/242329939_The_Effectiveness_of_the_Learning_to_BREATHE_Program_on_Adolescent_Emotion_Regulation

The Effectiveness of the Learning to BREATHE Program on ...

The purpose of this study was to assess the effectiveness of the mindfulness-based training program Learning to Breathe on adolescent ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6546608/

The effects of mindfulness‐based interventions on cognition ...

These data show that those completing MBIs improved significantly more than those in active control interventions for Mindfulness and there was also a greater ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7705247/

Learning to BREATHE “Plus”: A Multi-Modal Adaptive ...

There is growing evidence to support the effectiveness of Learning to BREATHE (L2B) (6), an MBI that is rooted in the philosophy of mindfulness ...

4.

learning2breathe.org

learning2breathe.org/research-2/

L2B Research

Results: Participation in the intervention was associated with significant increase in students' life satisfaction, and significant decrease in depression and ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2213398425000508

Mindfulness-based interventions for enhancing adolescent ...

Studies on mindfulness conducted among the adolescent age group showed promising results in overall well-being and mental health.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5871269/

Learning to BREATHE: A Pilot Study of a Mindfulness-Based ...

Mindfulness-based curricular interventions can support adolescents who are at risk of school failure as they negotiate the transition from high school into ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9524483/

Mindfulness-based school interventions: A systematic review ...

Nineteen of 77 eligible articles (25%) targeted mental health domain outcomes. Most studies reported reduced depression and anxiety symptoms (71% and 80%, ...

8.

withpower.com

withpower.com/trial/mindfulness-based-intervention-for-adolescent-mental-health-1f0cd

Mindfulness-Based Intervention for Adolescent Mental Health

Mindfulness-Based Interventions (MBIs) are generally considered safe for adolescents, with studies showing positive effects on mental health, such as reducing ...

9.

frontiersin.org

frontiersin.org/journals/public-health/articles/10.3389/fpubh.2020.579556/full

Learning to BREATHE “Plus”: A Multi-Modal Adaptive ...

Interventions that incorporate EMI may be more likely to result in lasting behavioral and mental health change for adolescents (27, 28) because ...