Maya App for Stress Management

Overseen By Stanley Watson, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Suicidal ideation

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

400 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 Maya App treatment for stress management?

Research on similar mobile apps, like PsyPills and Positive Technology, shows that they can help reduce stress by offering personalized advice and relaxation techniques. These apps, which are based on principles like cognitive behavioral therapy (CBT), have been found to effectively lower stress levels in users. ^{1 2 3 4 5}

Is the Maya App for Stress Management safe to use?

The Positive Technology app, which is similar to the Maya App, was evaluated in a small trial and users reported satisfactory experiences with no major safety concerns. However, data protection and privacy standards were noted to be poor in many similar apps, so users should be cautious about sharing personal information. ^{1 3 6 7 8}

What makes the Maya App treatment unique for stress management?

The Maya App is unique because it is a mobile app that uses Cognitive Behavioral Therapy (CBT) techniques to help manage stress, offering a self-help approach that can be accessed anytime on a smartphone. Unlike generic stress management apps, it may incorporate culturally relevant elements to better engage specific populations, making it more personalized and potentially more effective for diverse users. ^{1 3 7 9 10}

What is the purpose of this trial?

The purpose of this research study is to understand the biological mechanisms of stress vulnerability (being susceptible to stress) and stress resilience (being able to recover readily from stress), obtain biomarkers (a biological indicator) for stress resilience and to devise strategies for prevention and treatment of stress-related disorders.

Research Team

Huda Akil, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for incoming freshmen at the University of Michigan who are healthy and want to participate in a study about stress. Those with thoughts of suicide cannot join.

Inclusion Criteria

Incoming Freshmen Students at the University of Michigan

Exclusion Criteria

Suicidal Ideation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Maya mobile app, a CBT-based self-help app, for anxiety management

12 months

Assessments at baseline, 3, 6, 9, and 12 months

Follow-up

Participants are monitored for changes in anxiety and depressive symptoms using various scales

4 weeks

Treatment Details

Interventions

• Maya App

Trial Overview The Maya App is being tested to see if it can help identify biological indicators (biomarkers) that show how people handle stress, either by struggling with it or bouncing back easily.

Participant Groups

Group I: Maya mobile app Experimental Treatment 1 Intervention

Maya mobile app- CBT based self-help app

Group II: No Intervention Active Control 1 Intervention

Participants will complete assessments at baseline, 3 months, 6 months, 9 months and 12 months. (this includes specimen collections, interviews, and surveys). Participants will also be asked to wear a Fitbit for 12 months.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Pritzker Consortium

Collaborator

Trials

2

Recruited

610+

Findings from Research

The study identifies and evaluates free mobile applications available on the Android platform specifically designed for individuals with Post Traumatic Stress Disorder (PTSD), which can help users manage their symptoms and improve their quality of life.

By assessing the functionalities of these apps, the research aims to guide users seeking self-support and provide valuable insights for developers looking to create effective stress management tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Apps for Post Traumatic Stress Disorder. Drissi, N., Ouhbi, S., Idtissi, MAJ., et al.[2020]

The PsyPills app, designed for stress relief based on emotion regulation and Rational Emotive Behavior Therapy, showed effectiveness in reducing dysfunctional emotions among users, with significant improvements reported after accessing personalized psychological prescriptions.

In a study of 115 users over the first 6 months, those who received reminders to use the app experienced greater benefits, suggesting that timely prompts enhance its effectiveness for managing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Distress Using Mobile Prescriptions of Psychological Pills: A First 6-Month Effectiveness Study of the PsyPills App. David, OA., David, D.[2020]

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]

Standalone smartphone-based ecological momentary interventions (EMIs) based on cognitive behavioral therapy (CBT) principles have been shown to significantly improve well-being and reduce mental health symptoms among users, according to a review of 26 studies.

Users rated these EMIs as helpful and satisfying, indicating their potential as scalable and accessible mental health support, especially important during global crises like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standalone Smartphone Cognitive Behavioral Therapy-Based Ecological Momentary Interventions to Increase Mental Health: Narrative Review. Marciniak, MA., Shanahan, L., Rohde, J., et al.[2020]

A survey of 36 NHS e-therapy app developers revealed that a majority of both web (12 out of 13) and smartphone apps (20 out of 34) involved clinical expertise in their development, indicating a focus on safety and efficacy.

Most apps also demonstrated academic involvement and had published research backing their effectiveness, with many incorporating psychological theories, which suggests a commitment to using evidence-based practices in their design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

e-Therapies in England for stress, anxiety or depression: how are apps developed? A survey of NHS e-therapy developers. Bennion, MR., Hardy, GE., Moore, RK., et al.[2020]

A review of 3,278 mobile apps for anxiety disorders in Brazil found that only 71 met the eligibility criteria, with most apps focusing on education, self-assessment, and meditation, but only 43.66% were rated as having acceptable quality according to the Mobile App Rating Scale (MARS).

There was a notable discrepancy between user star ratings and the quality assessed by MARS, indicating that users should be cautious when selecting these apps for managing anxiety disorders, as many apps were classified as low quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of mobile applications focused on the care of patients with anxiety disorders: A systematic review in app stores in Brazil. Souza do Nascimento, V., Teotonio Rodrigues, A., Rotta, I., et al.[2023]

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]

Out of 555 mobile health apps targeting PTSD, only 69 met the criteria for inclusion, with an overall quality rating of medium, indicating that while some apps are based on effective cognitive behavioral therapy techniques, many lack rigorous scientific evaluation.

Most apps do not meet adequate data protection and privacy standards, and only one app was scientifically evaluated in a randomized controlled trial, highlighting the need for better quality control and evidence-based practices in the development of PTSD apps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Help for trauma from the app stores?' A systematic review and standardised rating of apps for Post-Traumatic Stress Disorder (PTSD). Sander, LB., Schorndanner, J., Terhorst, Y., et al.[2021]

The Journey to the West app is specifically designed for Asian international college students, addressing their unique mental health challenges, such as higher rates of depression and stigma around seeking help, which are often overlooked in generic stress management apps.

By integrating Cognitive Behavioral Therapy techniques into a culturally relevant role-playing game format, the app aims to enhance engagement and effectiveness in stress management, promoting social integration and resilience among its users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Cultural Contexts in the Management of Stress via Narrative and Mobile Technology. Lee, MD., Kang, X., Hanrahan, N.[2022]

A mobile application designed to enhance perceived control over anxiety significantly reduced salivary cortisol levels in patients undergoing endodontic treatment, indicating its effectiveness in managing anxiety.

In a study of 46 patients, those using the application showed significant reductions in cortisol levels at all stages of treatment, while the control group showed no changes, highlighting the app's potential as a useful tool for anxiety management in dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effectiveness of a mobile application in the management of dental anxiety: A randomised controlled trial. Nalci, G., Alaçam, T., Altunkaynak, B.[2022]

References

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

Mobile Apps for Post Traumatic Stress Disorder. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Managing Distress Using Mobile Prescriptions of Psychological Pills: A First 6-Month Effectiveness Study of the PsyPills App. [2020]

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

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

4. Canada pubmed.ncbi.nlm.nih.gov

Standalone Smartphone Cognitive Behavioral Therapy-Based Ecological Momentary Interventions to Increase Mental Health: Narrative Review. [2020]

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

e-Therapies in England for stress, anxiety or depression: how are apps developed? A survey of NHS e-therapy developers. [2020]

6. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of mobile applications focused on the care of patients with anxiety disorders: A systematic review in app stores in Brazil. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

'Help for trauma from the app stores?' A systematic review and standardised rating of apps for Post-Traumatic Stress Disorder (PTSD). [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing Cultural Contexts in the Management of Stress via Narrative and Mobile Technology. [2022]

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

Evaluation of the effectiveness of a mobile application in the management of dental anxiety: A randomised controlled trial. [2022]