Mindfulness Training for Mental Health Disorders

(STRIVE Trial)

Overseen By Ashley Flores, B.A.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Intellectual disability

Compensation: Varies

Number of Visits: 16

504 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mindfulness training, known as STRIVE, can assist high-achieving BIPOC students in managing stress and improving mental health. It focuses on students who often endure adversity in school, potentially leading to stress-related health issues. Participants will either receive mindfulness training or attend sessions on study skills. The goal is to determine if mindfulness can reduce stress and enhance well-being. Ideal candidates are 10th or 11th graders with a GPA above 3.5, attending a participating high school, and identifying as Black, Latinx, Asian American, or Indigenous. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance student well-being and academic success.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that the Learning to BREATHE program, which forms the basis of the STRIVE intervention, is generally safe for teenagers. This mindfulness program helps students manage their emotions and stress. Research indicates it is well-tolerated, with no major negative effects reported. Participants often feel less stressed and more aware of their emotions. No evidence of harm from this type of mindfulness training exists, making it a promising and safe method to support students with mental health challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STRIVE program because it offers a unique approach to managing mental health disorders through mindfulness. Unlike traditional therapies that may focus on medication or cognitive behavioral techniques, STRIVE uses mindfulness-based skills to help students better understand and regulate their emotions. This program is tailored specifically for high-achieving, college-bound BIPOC students, integrating mindfulness practices into daily life to offset the costs of resilience. By focusing on emotion regulation and self-awareness, STRIVE aims to provide a more holistic and culturally relevant tool for mental health support.

What evidence suggests that this trial's treatments could be effective for mental health disorders?

Research has shown that mindfulness programs like STRIVE, which participants in this trial may receive, can help people manage emotions and stress more effectively. The STRIVE program is based on the Learning to BREATHE curriculum, which has reduced negative feelings and increased calmness and relaxation in teens. Participants have reported feeling less stressed, experiencing fewer physical issues, and gaining better control over their emotions. This suggests that STRIVE might help students from marginalized communities manage mental health challenges related to their efforts to succeed. Another group in this trial will receive the Study Skills program, which focuses on supporting college readiness and achievement through study skills training. ^{1 3 6 7 8}

Who Is on the Research Team?

Anna Lau, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for high-achieving 10th or 11th graders from marginalized BIPOC communities, with a GPA above 3.5 or in the top 20% of their class, and enrolled in advanced courses at participating schools.

Inclusion Criteria

High achieving (e.g., GPA above 3.5 and/or in the top 20% of their grade, enrolled in advanced classes such as AP/IB/honors classes)

Identify as Black, Latinx, Asian American/Pacific Islander, or American Indian/Alaskan Native

I am a 10th or 11th grader at a participating school.

Exclusion Criteria

Intellectual Disability

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the STRIVE mindfulness-based intervention or the SOAR study skills curriculum in 12 1-hour sessions

12 weeks

12 visits (in-person)

Post-Assessment

Participants undergo post-assessment to evaluate changes in health and mental health outcomes

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including collection of biological samples and health assessments

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• STRIVE
• Study Skills

Trial Overview The trial tests if mindfulness training can help these students manage stress better than standard study skills training. It aims to see if this can reduce health issues and mental health problems caused by constant striving despite adversity.

How Is the Trial Designed?

Group I: STRIVE Experimental Treatment 1 Intervention

Based on the Learning to BREATHE (L2B) curriculum (Broderick, 2013), the STRIVE intervention is a mindfulness-based program designed to facilitate the development of emotion regulation for middle to high school students. Goals of the program include helping students understand their thoughts and feelings, learning how to use mindfulness-based skills to manage emotions, and providing opportunities for guided group mindfulness meditation practice. Delivered in twelve 60-minute group sessions, the intervention will be include the core components of the L2B program (i.e. body awareness; understanding and working with thoughts; understanding and working with feelings; integrating awareness of thoughts, feelings, and bodily sensations; reducing harmful self-judgments, and integrating mindful awareness into daily life) with content framed around the needs of high achieving, college-bound BIPOC students with the goal of offsetting the costs of resilience.

Group II: Study Skills Placebo Group 1 Intervention

The attention control condition will incorporate face-valid content to support college readiness and achievement in twelve 60- minute group sessions. Twelve sessions will cover the SOAR study skills curriculum (Kruger, 2017), including goal-setting, organization and time-management, and study skills for reading comprehension, writing papers, note-taking, and test-taking.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Fuller Theological Seminary

Collaborator

Trials

2

Recruited

530+

Claremont McKenna College

Collaborator

Trials

4

Recruited

820+

Fuller Seminary

Collaborator

Trials

1

Recruited

500+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Mindfulness meditation (MM) can have side effects, particularly related to mental health, physical health, and spiritual well-being, highlighting the need for safety considerations in research.

The paper provides practical tools for researchers, including screening procedures to assess participant contraindications and guidelines for MM training, based on a review of 17 primary studies and 5 secondary reports on meditation side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. Lustyk, MK., Chawla, N., Nolan, RS., et al.[2022]

Approximately two-thirds of participants in two studies (84 schoolteachers and 74 university students) reported unpleasant experiences during an 8-week mindfulness course, but most found these experiences to be only somewhat upsetting or even beneficial.

The incidence of reported harm from the mindfulness course was low, ranging from 3% to 7%, and only a small percentage (2% to 7%) showed reliable deterioration in psychological symptoms, indicating that while unpleasant experiences are common, serious negative effects are rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of Self-reported Unpleasant Events and Harm in a Mindfulness-Based Program in Two General Population Samples. Baer, R., Crane, C., Montero-Marin, J., et al.[2023]

A therapeutic education program based on mindfulness was developed in the 1990s to help combat depression and generalized anxiety disorder, focusing on being present without judgment.

In France, this program will be implemented in psychiatry, using meditation and psychoeducation to help patients with depression detach from their psychological and emotional content.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treating depression through mindfulness-based cognitive therapy]. Dulong, F.[2018]

Mindfulness Based Interventions (MBIs) have gained significant traction in recent years for their effectiveness in treating various psychiatric disorders, highlighting their growing importance in mental health care.

Research supports that MBIs work through cognitive, psychological, and neural mechanisms, making them a valuable addition to traditional treatment methods for improving mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions in Psychiatry. Shapero, BG., Greenberg, J., Pedrelli, P., et al.[2023]

Mindfulness-based stress reduction (MBSR) significantly reduced perceived stress and depression levels in 30 veterans over an 8-week program, indicating its potential efficacy for improving mental health.

Participants reported high satisfaction and compliance with the MBSR program, suggesting it is a feasible intervention for veterans with mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evaluation of mindfulness-based stress reduction for veterans with mental health conditions. Kluepfel, L., Ward, T., Yehuda, R., et al.[2013]

Mindfulness training led to significant improvements in psychological symptoms and quality of life for a diverse group of 143 psychiatric outpatients, indicating its overall efficacy as a therapeutic intervention.

However, patients with bipolar disorder did not show significant improvement, which may be linked to their longer illness duration and lower baseline severity compared to other diagnostic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. Bos, EH., Merea, R., van den Brink, E., et al.[2019]

The iMatter program, which teaches mindfulness and relaxation strategies to adolescents in a psychiatric hospital, showed positive effects, with participants reporting improved mood after sessions.

Physiological measures indicated that participants experienced a significant decrease in heart rate following mindfulness group sessions, suggesting a calming effect of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based group therapy: Impact on psychiatrically hospitalized adolescents. Sams, DP., Handley, ED., Alpert-Gillis, LJ.[2019]

The tailored mindfulness-based intervention (MBI) showed significant improvements in personal recovery, mindfulness, self-compassion, and resilience among participants with mental illness during the COVID-19 pandemic, with benefits maintained one month after the intervention.

Participants in the MBI group reported high acceptability of the program, while those in the relaxation training group experienced a decline in resilience over time, highlighting the potential advantages of MBI for long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial Among People Recovering from Mental Illness: A Tailored Mindfulness-Based Intervention versus Relaxation Training. Cheng, YTD., Young, KWD., Carlbring, P., et al.[2023]

Mindfulness-based therapies, particularly Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), have been shown to effectively improve psychological health, manage pain, and reduce anxiety symptoms.

MBCT is specifically recommended as an additional treatment for unipolar depression, highlighting its role in supporting mental health alongside traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation practices as adjunctive treatments for psychiatric disorders. Marchand, WR.[2022]

A self-guided, Internet-based mantram repetition program (MRP) was found to be feasible for undergraduate students, with 88.3% completing all modules and 76.7% responding to follow-up questions.

Participants reported practicing the mantram repetition an average of 4.46 days per week and 3.26 times per day, indicating a strong engagement with the program, which suggests potential for managing mental health challenges in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of a brief, Internet-based mantram repetition program for undergraduate students. Vannini, MBN., McLean, CL., Bormann, JE., et al.[2022]

Mindfulness-based interventions have strong evidence supporting their effectiveness in treating mental disorders, particularly depression and anxiety, by helping individuals change their relationship with unhelpful thoughts and emotions.

While home practice can be a barrier for some, it also provides practical tools that can aid in ongoing recovery and well-being, making mindfulness a valuable approach for both patients and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness in psychiatry - where are we now? Groves, P.[2020]

In a 21-day mindfulness-based intervention with 82 participants, 87% reported at least one momentary adverse effect during meditation, primarily anxiety, indicating that mindfulness practice can sometimes lead to temporary increases in anxiety.

Despite these momentary effects, 25% of participants experienced sustained adverse effects in daily life after the intervention, but these were not linked to the momentary effects during meditation, suggesting that increased awareness of internal states may contribute to these post-intervention challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. Aizik-Reebs, A., Shoham, A., Bernstein, A.[2021]

A study involving 191 participants using the VGZ Mindfulness Coach app showed significant improvements in mindfulness and reductions in psychiatric symptoms after 8 weeks, with a large effect size (Cohen's d = 0.77).

The benefits of using the app, including enhanced quality of life and sustained improvements in mindfulness facets, were maintained for at least 3 months, indicating its potential as a low-cost, effective tool for mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Mindfulness-Based Mobile Application: a Randomized Waiting-List Controlled Trial. van Emmerik, AAP., Berings, F., Lancee, J.[2020]

Citations

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

Learning to BREATHE: A Pilot Study of a Mindfulness-Based ... The results of several research studies with adolescents certainly indicate that mindfulness interventions can play a role in increasing self-regulatory skills.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05619458

Effectiveness of a Mindfulness Program on Emotion ... Learning to BREATHE teaches emotion regulation and stress-reduction in relatable ways for teens. The program is delivered flexibly and adaptively rather than as ...

3. learning2breathe.org learning2breathe.org/research-2/

L2B Research Relative to controls, participants reported decreased negative affect and increased feelings of calmness, relaxation, and self-acceptance. Improvements in ...

4. 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 ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/15427609.2013.818488

The Effectiveness of the Learning to BREATHE Program on ... Program participants reported statistically lower levels of perceived stress and psychosomatic complaints and higher levels of efficacy in affective regulation.

6. learning2breathe.org learning2breathe.org/

Learning to BREATHE | A Mindfulness Curriculum for ... Learning to BREATHE is an evidence-based mindfulness curriculum created for classroom and clinical settings.

7. researchgate.net researchgate.net/publication/264499592_Learning_to_BREATHE_An_intervention_to_foster_mindfulness_in_adolescence

An intervention to foster mindfulness in adolescence Learning to BREATHE is designed to help cultivate emotion regulation, attention, and performance, teach stress management, and help students ...

8. newharbinger.com newharbinger.com/blog/professional/research-round-up-new-study-shows-efficacy-of-learning-to-breathe-curriculum/?srsltid=AfmBOoq9KNzQwzpA11JyhBQa4bgJRUp14l3lYiTLhbwBMQAt-2G8lIdI

Research Round-Up: New study shows efficacy of ... Results showed a mean reduction in the L2B group's lack of emotional awareness, and yet a larger reduction in psychosomatic symptoms from pretest to posttest as ...