Meditation App for Stress Management

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Illinois at Chicago

No Placebo Group

Trial Summary

What is the purpose of this trial?

This feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with officers in the juvenile legal system and other professionals working directly with legal-involved youth.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment Action In Mindfulness (AIM)+, Mindfulness Program, Meditation App for stress management?

Research shows that mindfulness meditation programs, like the one used in the AIM+ treatment, can help manage stress and improve outcomes in various settings, such as psychiatric units and among diverse populations. Additionally, mobile mindfulness apps have been found to be feasible and acceptable for improving sleep quality and managing symptoms in different groups. ^{1 2 3 4 5}

Is the Meditation App for Stress Management generally safe for humans?

Research on mindfulness meditation, including apps, shows that while it can have mental health benefits, there are potential side effects like mental, physical, and spiritual health issues. It's important for participants to be screened properly to minimize risks. ^{6 7 8 9 10}

How is the Meditation App for Stress Management treatment different from other stress management treatments?

The Meditation App for Stress Management is unique because it delivers a mindfulness-based protocol through a smartphone app, allowing users to practice meditation conveniently and independently. Unlike traditional stress management methods, this app-based approach provides flexibility in practice frequency and can be used intermittently, which may be beneficial for some users. ^{2 4 11 12 13}

Research Team

Eligibility Criteria

This trial is for officers and professionals working with youth in the juvenile legal system. It's designed to see if using a meditation app can help them manage emotions, depression, burnout, and anxiety over one month.

Inclusion Criteria

I am 18 years old or older.

I understand the study and can give my consent.

Have an Android or Apple smartphone

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 1-month app-based meditation program using the AIM+ mindfulness meditation app or the Resource+ informational resource app

4 weeks

App-based, no in-person visits required

Follow-up

Participants are monitored for changes in anxiety, perceived stress, mood regulation, and other psychological measures

6 months

Treatment Details

Interventions

• Action In Mindfulness (AIM)+ (Behavioral Intervention)

Trial Overview The trial is testing two app-based meditation programs: Resource+ and Action In Mindfulness (AIM)+. Participants will use these apps regularly to explore their effectiveness in improving mental well-being.

Participant Groups

Group I: Action In Mindfulness (AIM)+ Experimental Treatment 1 Intervention

Participants randomized to the intervention arm will receive the AIM+ mindfulness meditation app.

Group II: Resource+ Active Control 1 Intervention

Participants randomized to the active control arm will receive the Resource+ informational resource app.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Mark I. Rosenblatt

University of Illinois at Chicago

Chief Executive Officer

MD, PhD, MBA, MHA

Jon Radosta

University of Illinois at Chicago

Chief Medical Officer since 2023

MD

Findings from Research

The mindfulness-based stress reduction (MBSR) program significantly helped mental health professionals reduce their work stress and improve their self-care, which in turn enhanced patient care.

Participants in the MBSR program reported increased patient satisfaction and a reduction in patient safety events, indicating a positive impact on both staff well-being and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of mindfulness meditation in promoting a culture of safety on an acute psychiatric unit. Brady, S., O'Connor, N., Burgermeister, D., et al.[2012]

A qualitative study involving 17 adults found that a mindfulness meditation app (Headspace) was generally acceptable and helped users improve their sleep quality, especially for those who used it consistently in the evenings.

Participants expressed a need for personalized features in the app, with specific preferences noted among Black/African American users for instructors that reflect their race and gender, suggesting that tailored approaches could enhance engagement and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, appropriateness, and acceptability of a mobile mindfulness meditation intervention to improve sleep quality among a racially/ethnically diverse population. Johnson, LCM., Aiello, JJ., Jagtiani, A., et al.[2023]

The article reviews the Calm app, which focuses on mindfulness meditation, highlighting its potential benefits for clinical practice.

Mindfulness meditation apps like Calm may offer accessible tools for mental health support, although specific efficacy data or study details are not provided in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calm: A review of the mindful meditation app for use in clinical practice. May, AD., Maurin, E.[2021]

The study involving 269 university students found that using the Calm app for mindfulness, even intermittently, led to significant improvements in wellbeing, trait mindfulness, and self-efficacy, indicating its effectiveness as a mental health tool.

While regular use of the app is beneficial, the research suggests that daily practice is not necessary for positive outcomes, and some users reported negative experiences, highlighting the need for customizable features in mindfulness apps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent mindfulness practice can be beneficial, and daily practice can be harmful. An in depth, mixed methods study of the "Calm" app's (mostly positive) effects. Clarke, J., Draper, S.[2022]

The mobile mindfulness-based stress reduction program (mMBSR(BC)) was found to be feasible and acceptable for breast cancer survivors, with significant improvements in psychological and physical symptoms after 6 weeks of use.

Participants showed medium to large effect size improvements in symptoms such as depression, anxiety, stress, and quality of life, indicating that this mobile intervention can effectively reduce symptom burden during the survivorship phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program for symptom improvement among breast cancer survivors. Lengacher, CA., Reich, RR., Ramesar, S., et al.[2022]

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]

In two studies involving 143 participants, both Muse-assisted relaxation exercises (MARE) and unassisted relaxation exercises (URE) led to similar short-term increases in heart rate variability (HRV), indicating that both methods are effective for promoting relaxation.

The use of the Muse neurofeedback device did not provide any additional benefits over traditional relaxation techniques, suggesting that mindfulness practices can be effective even without technological assistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commercial mindfulness aid does not aid short-term stress reduction compared to unassisted relaxation. Svetlov, AS., Nelson, MM., Antonenko, PD., et al.[2020]

Mindfulness-based stress reduction (MBSR) has been shown to improve mental health and reduce symptoms of stress, anxiety, and depression across 31 randomized studies involving both clinical and non-clinical populations.

The implementation of MBSR in the healthcare system is recommended to be gradual, ensuring that MBSR teachers in Denmark receive adequate training and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. Fjorback, LO., Rasmussen, BH., Preuss, T.[2019]

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 review of 93 studies found that meditation apps, particularly Headspace, primarily focus on mindfulness meditation and are most commonly used to address stress-related health issues.

Future research should explore the effects of meditation apps on a broader range of mental health conditions beyond just stress to fully understand their potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Features of Meditation Apps: A Scoping Review. Muhiyaddin, R., Abd-Alrazaq, A., Alajlani, M., et al.[2022]

References

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

The impact of mindfulness meditation in promoting a culture of safety on an acute psychiatric unit. [2012]

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

Feasibility, appropriateness, and acceptability of a mobile mindfulness meditation intervention to improve sleep quality among a racially/ethnically diverse population. [2023]

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

Calm: A review of the mindful meditation app for use in clinical practice. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Intermittent mindfulness practice can be beneficial, and daily practice can be harmful. An in depth, mixed methods study of the "Calm" app's (mostly positive) effects. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Feasibility of the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program for symptom improvement among breast cancer survivors. [2022]

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

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

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

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Commercial mindfulness aid does not aid short-term stress reduction compared to unassisted relaxation. [2020]

9. Denmark pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]

10. England pubmed.ncbi.nlm.nih.gov

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

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

Does a meditation protocol supported by a mobile application help people reduce stress? Suggestions from a controlled pragmatic trial. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Features of Meditation Apps: A Scoping Review. [2022]

13. Canada pubmed.ncbi.nlm.nih.gov

Effects of a 12-Minute Smartphone-Based Mindful Breathing Task on Heart Rate Variability for Students With Clinically Relevant Chronic Pain, Depression, and Anxiety: Protocol for a Randomized Controlled Trial. [2020]