Mindfulness App for Stress Relief

Overseen By Karen Alexander, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: COG Analytics

Disqualifiers: Inability to provide informed consent

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mindfulness app designed to reduce stress for African American caregivers of people living with HIV/AIDS. The goal is to determine if this app can ease stress management and the pressures of caregiving. Participants will use the Mindfulness Based Stress Reduction App for eight weeks, while others will receive information on caregiver services for comparison. This trial suits those who are the main caregivers for someone with HIV/AIDS and regularly face stress related to this role. As an unphased trial, it offers caregivers the chance to explore innovative stress-reduction techniques tailored to their unique challenges.

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

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

What prior data suggests that this mindfulness app is safe for stress relief?

Research shows that mindfulness-based stress reduction (MBSR) programs, like the one in this app, are generally safe. Studies have found that these programs can help reduce anxiety, depression, and stress. Evidence suggests that MBSR apps offer a practical way to deliver these benefits.

Most studies report few risks with mindfulness and meditation practices. However, not many studies have explored potential harmful effects. So far, available data indicates that mindfulness apps are well-tolerated and safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness Based Stress Reduction App because it offers a convenient, digital approach to managing stress, potentially reaching people who might not have access to traditional in-person therapy or stress management programs. Unlike standard treatments that may require face-to-face sessions, this app can be used anytime and anywhere, making it highly accessible. Additionally, the app focuses on mindfulness, a technique proven to help reduce stress, but it packages it in a user-friendly digital format that could engage users more effectively. This innovative delivery method could make stress relief more attainable for a wider audience.

What evidence suggests that this mindfulness app is effective for stress relief?

Research shows that Mindfulness-Based Stress Reduction (MBSR) programs can help lower stress, anxiety, and depression. This trial will test the effectiveness of the Mindfulness-Based Stress Reduction App (MBSR-AAC app) for stress relief. Studies have found that mindfulness apps can offer similar benefits by making mindfulness practices easier to access. For instance, the app "Calm" significantly reduced stress and boosted self-kindness in stressed college students. A review of multiple studies also found that mobile health apps for stress relief work well in everyday settings. This suggests that a mindfulness app could be a useful tool for managing stress and improving well-being. ^{1 2 4 6 7}

Who Is on the Research Team?

Steven B Carswell, Ph.D.

Principal Investigator

COG Analytics

Are You a Good Fit for This Trial?

This trial is for African American adults aged 18 or older who are the main unpaid caregivers to someone living with HIV/AIDS. It aims to support those facing stress from caregiving and stigma.

Inclusion Criteria

I am over 18, African American, and the main unpaid caregiver for someone with HIV/AIDS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MBSR-AAC app or caregiver resources for 8 weeks

8 weeks

Follow-up

Participants are monitored for caregiver self-compassion, stress, relationships, burden, depressive and anxiety symptoms, and stigma and discrimination

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Based Stress Reduction App

Trial Overview The trial is testing a mindfulness-based stress reduction app designed specifically for African American caregivers of people with HIV/AIDS, assessing its effectiveness in reducing stress and improving relationships.

How Is the Trial Designed?

Group I: MBSR-AAC app Experimental Treatment 1 Intervention

Participants will receive the MBSR-AAC app for 8-weeks.

Group II: Comparison Active Control 1 Intervention

Participants will receive information regarding caregiver services and resources for 8-weeks.

Who Is Running the Clinical Trial?

COG Analytics

Lead Sponsor

Trials

4

Recruited

1,200+

Friends Research Institute, Inc.

Collaborator

Trials

60

Recruited

22,500+

Published Research Related to This Trial

A 4-week randomized controlled trial involving 561 university students and staff found that using a mindfulness app led to small reductions in stress and depression, with effect sizes of 0.16 for both outcomes.

Despite a 28% dropout rate, the study suggests that mindfulness apps can provide modest but clear benefits for mental health, making them a promising supplement to traditional mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of app-based mindfulness practice on the well-being of university students and staff. Lahtinen, O., Aaltonen, J., Kaakinen, J., et al.[2023]

The Positive Technology app, designed for self-management of psychological stress, includes guided relaxation, 3D biofeedback, and stress tracking, showing promise in reducing perceived stress levels based on user feedback from a trial with 32 participants.

Participants reported satisfactory experiences with the app, and those using it with a wrist sensor demonstrated enhanced capabilities for monitoring and managing stress, indicating potential for further development in usability and advanced features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive technology: a free mobile platform for the self-management of psychological stress. Gaggioli, A., Cipresso, P., Serino, S., et al.[2018]

A systematic review of ten studies on technology-based mindfulness interventions found significant clinical effects on stress, depression, and anxiety, with large effect sizes reported for stress (d = 1.57) and depression (d = 0.95).

Despite promising results, the studies had methodological limitations such as selection bias and lack of control groups, indicating that further research is needed to refine these interventions and establish their effectiveness more reliably.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes? Fish, J., Brimson, J., Lynch, S.[2022]

Out of 902 stress management apps evaluated, only 60 met the criteria for including evidence-based strategies, with 33% of those not delivering any evidence-based content.

The most common strategies found in the effective apps were mindfulness and meditation (73%) and diaphragmatic breathing (25%), indicating that these approaches are prevalent in mobile stress management solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic, Multi-domain Review of Mobile Smartphone Apps for Evidence-Based Stress Management. Coulon, SM., Monroe, CM., West, DS.[2022]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7511255/

The Effectiveness of Mindfulness-Based Stress Reduction ... The reviewed literature suggested that MBSR was effective in reducing HCPs experiences of anxiety, depression and stress.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0272735824001363

Efficacy of app-based mobile health interventions for stress ... This systematic review and meta-analysis aimed to investigate the effects of mHealth apps designed primarily to reduce stress and distress in non-clinical and ...

3. mhealth.jmir.org mhealth.jmir.org/2019/6/e14273

Efficacy of the Mindfulness Meditation Mobile App “Calm” to ... Calm is an effective modality to deliver mindfulness meditation in order to reduce stress and improve mindfulness and self-compassion in stressed college ...

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1347336/full

Exploring the sustained impact of the Mindfulness-Based ... Results: The findings revealed that the effectiveness of the MBSR program varied at different times and across different variables. Immediately ...

5. nature.com nature.com/articles/s44184-023-00048-5

The impact of mindfulness apps on psychological ... Mindfulness-based interventions (MBIs) have demonstrated efficacy in improving a range of clinical outcomes, such as depression and anxiety. In ...

6. healthline.com healthline.com/health/mindfulness-based-stress-reduction

Mindfulness-Based Stress Reduction: History, Benefits & ... Mindfulness-based stress reduction is an 8-week program designed to bring about a greater sense of mental well-being. Get the details.

7. nccih.nih.gov nccih.nih.gov/health/meditation-and-mindfulness-effectiveness-and-safety

Meditation and Mindfulness: Effectiveness and Safety | NCCIH Meditation and mindfulness practices usually are considered to have few risks. However, few studies have examined these practices for potentially harmful ...