Meditation App for Stress Management

Overseen By Ashley D Kendall, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Non-English speakers, Under 18, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a meditation app can reduce stress for those working with youth in the juvenile legal system. Participants will use either the AIM+ mindfulness meditation app or the Resource+ informational app to determine which is more effective. The goal is to assess if these tools are user-friendly and helpful for managing stress. Suitable candidates work with youth in the juvenile legal system, speak English, and own a smartphone. As an unphased trial, this study provides a unique opportunity to explore innovative stress management tools that could enhance well-being.

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 prior data suggests that this meditation app is safe for stress management?

Research shows that meditation apps, such as Action In Mindfulness (AIM)+, are generally easy to use and safe. Studies have found that these apps can improve well-being and reduce workplace stress. Most users of these mindfulness programs experience few side effects. Although reports of unwanted effects are rare and not well-documented, some side effects might occur, but they are neither common nor serious. Overall, using a mindfulness app is considered safe for most people, particularly for managing stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Action In Mindfulness (AIM)+ app because it offers a unique approach to stress management by integrating mindfulness meditation into a digital format. Unlike traditional stress management techniques, which often involve in-person therapy or medication, AIM+ provides a convenient, self-guided experience that users can access anytime through their smartphones. This app not only makes mindfulness more accessible but also encourages consistent practice, which is key to effectively managing stress. By leveraging technology, AIM+ aims to make stress reduction more achievable for a wider audience.

What evidence suggests that this trial's treatments could be effective for stress management?

Research shows that mindfulness meditation programs, such as AIM+, which participants in this trial may receive, can help manage stress and improve well-being in various situations. One study found that mindfulness apps reduced stress and work-related problems for university employees. Mindfulness-based therapy has proven effective in lowering stress in over 200 studies. Additionally, evidence suggests these apps can also help reduce symptoms of depression and anxiety. Overall, the data indicates that mindfulness apps like AIM+ can be helpful for managing stress. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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 understand the study and can give my consent.

Currently working with youth in the juvenile legal system or related juvenile services and programming

English speaking

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Action In Mindfulness (AIM)+

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.

How Is the Trial Designed?

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+

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]

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]

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]

The study aims to evaluate the effects of the Mindfulness Meditation app (MMA) on heart rate variability (HRV), pain, and mood symptoms in participants with chronic pain and depression or anxiety, with a target of at least 60 participants in each group.

Preliminary results suggest that participants using the MMA are expected to show a significant increase in HRV compared to those not using the app, indicating potential benefits of the app in managing psychological and physical symptoms.

NCBI (Pubmed)

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. Azam, MA., Latman, VV., Katz, J.[2020]

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]

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]

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]

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]

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]

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]

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]

A 3-week mindfulness protocol delivered via a smartphone app did not show significant differences in stress reduction compared to a control group listening to relaxing music, but both groups reported improvements in coping with stress.

Participants in both the meditation and music groups experienced a significant decrease in heart rate after each session, indicating a physiological response to the interventions that may contribute to stress reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a meditation protocol supported by a mobile application help people reduce stress? Suggestions from a controlled pragmatic trial. Carissoli, C., Villani, D., Riva, G.[2022]

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]

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Meditation App for Stress Management

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Mindfulness App Training for Cardiovascular Health

The objective is to determine the program's effectiveness in reducing stress levels and cardiovascular responses to stress in the daily lives of participants, ...