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

Trial Summary

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 data supports the effectiveness of the Mindfulness Based Stress Reduction App treatment for stress relief?

Research shows that mindfulness apps, like the Calm app, can help reduce stress, depression, and anxiety when used regularly. Although the evidence is still developing, studies have found significant positive effects, suggesting that these apps can be a useful tool for managing stress. ^{1 2 3 4 5}

Is the Mindfulness App for Stress Relief safe to use?

Mindfulness apps are generally considered safe, but some users have reported both positive effects like reduced stress and negative effects such as increased distress or dependency. It's important to be aware of these potential outcomes when using mindfulness apps. ^{6 7 8 9 10}

How does the Mindfulness Based Stress Reduction App differ from other stress relief treatments?

The Mindfulness Based Stress Reduction App is unique because it offers a convenient, app-based approach to mindfulness practice, which can be used anytime and anywhere, unlike traditional in-person mindfulness sessions. It provides guided relaxation and stress tracking features, making it a flexible and accessible option for managing stress. ^{1 2 6 11 12}

What is the purpose of this trial?

African American caregivers of people living with HIV/AIDS (PLWHA) have unique needs because they are more likely to experience stressors related to intersecting sources of stigma, discrimination, and caregiving burdens specifically associated with caregiving for PLWHA. The proposed project will enhance and finalize Phase I app development and evaluate its effectiveness in a randomized controlled trial. The project has high public health significance because of its potential to provide an accessible, easy to use mindfulness-based support tool for African American caregivers that could reduce stress, mitigate the harm of intersecting stigmas, and strengthen the caregiver-care recipient relationship.

Research Team

Steven B Carswell, Ph.D.

Principal Investigator

COG Analytics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

References

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

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

2. 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]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A Systematic, Multi-domain Review of Mobile Smartphone Apps for Evidence-Based Stress Management. [2022]

4. England pubmed.ncbi.nlm.nih.gov

By the numbers: ratings and utilization of behavioral health mobile applications. [2023]

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

Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes? [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Positive technology: a free mobile platform for the self-management of psychological stress. [2018]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Practicing Mindfulness through mHealth Applications: Emerging Adults' Health-Enhancing and Inhibiting Experiences. [2023]

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

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

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

The effects of app-based mindfulness practice on the well-being of university students and staff. [2023]

12. 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]