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

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how people handle stress, examining why some are more affected while others recover easily. Researchers use the Maya app, a tool based on cognitive-behavioral therapy, to determine its effectiveness in managing stress. The trial targets incoming freshmen at the University of Michigan. Participants will use the app, undergo assessments, and wear a Fitbit for a year to track stress levels and responses. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research on stress management.

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 the Maya App is safe for stress management?

Research has shown that the Maya App, which incorporates techniques from Cognitive Behavioral Therapy (CBT), is generally user-friendly. Studies have found that apps like Maya can help reduce anxiety, positively impacting mental health. In studies involving the app, no major negative side effects have been reported.

As a self-help tool, the Maya App allows users to work through therapy exercises at their own pace, making the approach safe by letting individuals progress as they feel comfortable. The absence of a specific trial phase suggests the app is considered safe enough for use without extensive additional testing. If side effects occur, they are likely to be minor, given the app's design. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Maya App is unique because it offers a self-help approach to stress management through a mobile platform, making it accessible anytime and anywhere. Unlike traditional therapy or medication that often requires scheduled visits or prescriptions, the app uses Cognitive Behavioral Therapy (CBT) techniques to help users manage stress on their own. Researchers are excited about this treatment because it empowers individuals to take control of their mental health in a flexible and user-friendly way, potentially increasing engagement and effectiveness.

What evidence suggests that the Maya App is effective for stress management?

Research shows that the Maya App, which incorporates techniques from Cognitive Behavioral Therapy (CBT), can help manage anxiety. Studies have found that self-guided CBT apps like Maya significantly reduce anxiety symptoms in young adults. In this trial, participants in the experimental arm will use the Maya App. Previous research indicates that users of the app felt noticeably less anxious by the end of their treatment. The app offers a self-help approach, making it a convenient choice for those who want to manage stress and anxiety independently. These positive results suggest that the Maya App might enhance resilience to stress and improve overall mental well-being. ^{3 4 5 6 7}

Who Is on the Research Team?

Huda Akil, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Hope for Depression Research Foundation

Collaborator

Trials

4

Recruited

1,400+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Pritzker Consortium

Collaborator

Trials

2

Recruited

610+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822451

Efficacy of a Mobile App-Based Intervention for Young ... The findings of this study suggest that self-guided mobile cognitive behavioral therapy apps can be efficacious in improving anxiety symptoms.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39163044/

Efficacy of a Mobile App-Based Intervention for Young Adults ... Main outcomes and measures: The primary outcome was change in anxious symptoms from baseline to end of treatment, as measured by the Hamilton ...

3. nyp.org nyp.org/news/cognitive-behavioral-therapy-app-improves-anxiety-in-young-adults

Cognitive Behavioral Therapy App Improves Anxiety in ... A self-guided cognitive behavioral therapy (CBT) app, called Maya, significantly reduced anxiety in young adults struggling with mental health challenges.

4. withpower.com withpower.com/trial/phase-healthy-subjects-hs-7-2022-246ec

Maya App 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 ...

5. heady.io heady.io/work/maya

Maya by Weill Cornell - Case Study A clinical study published in August 2024 found that using the Maya app significantly reduced anxiety in young people. The findings of this study suggest that ...

6. researchprotocols.org researchprotocols.org/2025/1/e59461

Feasibility of a Mobile App–Based Cognitive-Behavioral ... Maya-Perinatal Skills Program (M-PSP) is a 12-session mobile app–based program teaching evidence-based strategies to manage mood and anxiety ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05754151

Mobile CBT for Middle Aged and Older Adults This study aims to assess a mobile iPhone app called MAYA for use in middle-aged and older adults with anxiety or mood disorders.