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

Trial Summary

What is the purpose of this trial?

Students in marginalized communities who 'strive' to rise above adversity to achieve academic success are considered 'resilient'. However, youths' resilience in one domain (i.e. academic) can come at a cost in other domains including physical and mental health morbidities that are under-identified and under-treated. Previous research suggests that Black, Indigenous and People of Color (BIPOC) who exhibit a "striving persistent behavioral style" in the face of adversity evince later health morbidities. Ironically, the same self-regulatory skills that promote academic achievement amid chronic stress can also result in physiological dysregulation that harms health and mental health. Self-regulatory processes that involve emotion suppression, experiential avoidance, and unmodulated perseverance can culminate in allostatic load which fuels health disparities and internalizing symptoms of depression and anxiety. The proposed mechanistic trial will utilize mindfulness training to permit examination of questions about the causal role of emotion regulation strategies linked to the striving persistent behavioral style in driving mental health and health morbidities among BIPOC. The proposed Project STRIVE (STudents RIsing aboVE) will identify BIPOC students who are academically resilient in the face of disadvantage and will offer a tailored mindfulness intervention targeting self-regulation processes as a putative mechanism to interrupt the links between the striving persistent behavioral style and negative health outcomes. Investigators propose a multisite randomized trial randomizing 504 high achieving, socioeconomically disadvantaged Black, Latinx and Asian American students in 18 schools to receive a mindfulness intervention or an attention control condition focused on study skills. The study will: (1) test the effects of the STRIVE intervention on putative self-regulation mechanisms (emotion suppression, experiential avoidance, and unmodulated perseverance) among identified BIPOC students, (2) test the effects of the STRIVE intervention on health and mental health outcomes at 12-month post-treatment, including biomarkers of allostatic load (cortisol, blood pressure, body-mass-index, waist/hip/neck circumference), health complaints, and internalizing symptoms, and (3) examine the mechanistic model linking striving persistent behavioral style and health outcomes within the STRIVE trial.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment STRIVE, Study Skills in the clinical trial Mindfulness Training for Mental Health Disorders?

Research shows that mindfulness-based interventions can improve mood and reduce stress in people with mental health conditions, including adolescents and veterans. These interventions help individuals focus on the present moment, which can lead to psychological improvements. ^{1 2 3 4 5}

Is mindfulness training generally safe for humans?

Research on mindfulness training shows that while it can have positive effects, there are some reports of unpleasant experiences and potential side effects, especially related to mental health. However, these adverse effects are not well-studied, and more research is needed to fully understand the safety of mindfulness practices. ^{4 6 7 8 9}

How is the treatment STRIVE different from other treatments for mental health disorders?

STRIVE is unique because it incorporates mindfulness training, which focuses on being fully present and non-judgmental, helping patients change their relationship with negative thoughts and emotions. Unlike traditional treatments, it emphasizes home practice, which can be both a challenge and a tool for long-term recovery. ^{4 10 11 12 13}

Research Team

Anna Lau, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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)

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

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

Exclusion Criteria

Intellectual Disability

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based group therapy: Impact on psychiatrically hospitalized adolescents. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions in Psychiatry. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The evaluation of mindfulness-based stress reduction for veterans with mental health conditions. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial Among People Recovering from Mental Illness: A Tailored Mindfulness-Based Intervention versus Relaxation Training. [2023]

6. England pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a Mindfulness-Based Mobile Application: a Randomized Waiting-List Controlled Trial. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Frequency of Self-reported Unpleasant Events and Harm in a Mindfulness-Based Program in Two General Population Samples. [2023]

10. France pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

The feasibility of a brief, Internet-based mantram repetition program for undergraduate students. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

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

13. England pubmed.ncbi.nlm.nih.gov

Mindfulness in psychiatry - where are we now? [2020]