Mobile Cognitive Behavioral Therapy App for Anxiety and Depression

Overseen By Zareen Mir

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Neurologic disorder, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: 18

Duration: 6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile therapy app to determine if a personalized program is as effective as a general one in reducing anxiety and depression symptoms. Participants will use the General MAYA Mobile App on their iPhones for two days a week, 20 minutes each day, over six weeks. The trial seeks individuals aged 18-25 who have been diagnosed with anxiety, depression, or bipolar disorder and own an iPhone. The goal is to discover if the personalized app can provide quicker and more targeted assistance for mental health challenges. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions.

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

The trial does not specify if you need to stop your current medications, but you cannot join if you've changed your psychiatric medication dose in the past 12 weeks.

What prior data suggests that this mobile cognitive behavioral therapy app is safe for treating anxiety and depression?

Research shows that mobile cognitive behavioral therapy (CBT) apps are generally safe for users. Studies have found that these apps can effectively help with anxiety and depression without causing major side effects. For instance, self-guided CBT apps have improved anxiety symptoms, indicating they are well-tolerated.

The personalized mobile CBT app tested in this trial resembles other CBT apps that have shown positive results. Although specific data on side effects for this personalized app is not available, research on similar apps suggests they are safe to use. Participants usually do not report major problems, making these apps a promising option for those seeking help with anxiety and depression.

Overall, evidence supports the safety of mobile CBT apps. They offer a convenient way to manage mental health with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Cognitive Behavioral Therapy (CBT) apps because they offer a new way to tackle anxiety and depression. Unlike traditional treatments that often involve in-person therapy or medications, these apps provide a convenient, mobile-based approach that can be personalized for each user. The personalized app tailors the CBT techniques to the individual's specific needs, potentially increasing effectiveness and user engagement. On the other hand, the general app offers a more standardized CBT approach, making it accessible to a wide audience. This digital method could make therapeutic techniques more accessible and flexible, fitting seamlessly into users' daily lives.

What evidence suggests that this trial's treatments could be effective for anxiety and depression?

Research has shown that self-guided mobile apps for cognitive behavioral therapy (CBT) can effectively reduce anxiety symptoms. These apps also help with other mental health issues like depression and stress. In this trial, participants will receive either a personalized CBT app or a general non-personalized CBT app. Personalized CBT apps, which adjust to fit individual needs, are expected to enhance treatment for anxiety disorders. Reviews and studies support the effectiveness of mobile CBT for mental health conditions. This evidence suggests that both general and personalized CBT apps, tested in this trial, can be promising tools for improving symptoms of anxiety and depression. ^{4 5 6 7 8}

Who Is on the Research Team?

Jennifer Bress, Ph.D.

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-25 with anxiety, depression, or bipolar disorder (currently in a depressive episode), who haven't started new psychotherapy or changed medication doses in the last 12 weeks. It's not for those with psychotic disorders, current manic episodes, or immediate suicide risk.

Inclusion Criteria

I have bipolar disorder and am currently stable or depressed.

I have been diagnosed with anxiety, depression, or bipolar disorder.

Exclusion Criteria

Lifetime diagnosis of a psychotic disorder

Current hypomanic or manic episode

My psychiatric medication dose hasn't changed in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Maya app for cognitive behavioral therapy, either personalized or general, for 6 weeks

6 weeks

Weekly check-ins with research team, optional MRI and EEG at baseline and week 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Follow-up assessment at week 12

What Are the Treatments Tested in This Trial?

Interventions

• General MAYA Mobile App
• Personalized Mobile Cognitive Behavioral Therapy Application

Trial Overview The study compares two mobile apps delivering cognitive behavioral therapy: a standard version and a personalized one that introduces skills faster. Participants will use an app twice weekly for six weeks and undergo assessments including questionnaires and optional brain scans.

How Is the Trial Designed?

Group I: Personalized Experimental Treatment 1 Intervention

Participants receive the personalized Maya app intervention for 6 weeks

Group II: General Non-Personalized Active Control 1 Intervention

Participants receive the general MAYA app intervention for 6 weeks

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Children's Health Fund

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

Mobile phone applications can enhance cognitive behavioral therapy (CBT) by providing tools for clients to record and manage anxiety-provoking situations, making therapy more accessible and personalized.

The use of multimedia in mobile CBT allows clients to better express their thoughts and feelings, facilitating communication with therapists and support networks, which can improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone computing for in-situ cognitive behavioral therapy. Bang, M., Timpka, T., Eriksson, H., et al.[2018]

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 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]

A digital mental health program providing internet-based cognitive behavioral therapy (iCBT) was successfully implemented in primary care, with 2,228 patients prescribed the program and nearly 49% enrolling, indicating good acceptance among patients.

Patients who engaged with the iCBT program showed significant clinical improvements, with a 23% reduction in depression scores (PHQ-9) and a 26% reduction in anxiety scores (GAD-7), demonstrating the efficacy of digital tools in treating mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. Sharif-Sidi, Z., Shen, C., Wong, W., et al.[2021]

The gamified smartphone-based intervention, mentalis Phoenix (MT-Phoenix), was tested in a pilot trial with 77 participants and showed a significant reduction in depressive symptoms compared to a waitlist control, with a large effect size (d=1.02).

Participants engaged with the intervention for an average of 46% of the days over a 14-day period, and the positive effects on depression were sustained at a 3-month follow-up, indicating both efficacy and potential for long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Gamified Smartphone-Based Intervention for Depression: Randomized Controlled Pilot Trial. Lukas, CA., Eskofier, B., Berking, M.[2021]

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]

In a pilot study involving 33 veterans, the Moving Forward app was tested alongside problem-solving therapy (PST) and showed high satisfaction and reductions in depression, anxiety, and stress among participants.

Veterans using the app reported effective skills practice and found it valuable, suggesting that the app could help reduce barriers to mental health care in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Problem-Solving Therapy With Smartphone Technology: A Pilot Randomized Controlled Trial. Grubbs, KM., Abraham, TH., Pyne, JM., et al.[2022]

A systematic review of mobile health apps for depression found that 74% of the evaluated apps had acceptable quality, with 32% scoring 4.0 or higher on the Mobile Application Rating Scale (MARS), indicating their potential effectiveness.

These high-quality apps can enhance patient self-management and treatment engagement, suggesting they may be valuable tools for individuals with depression who face barriers to traditional treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Commercially Available Mobile Apps for Depression Self-Management. Myers, A., Chesebrough, L., Hu, R., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11808676/

Efficacy of a process-based, Mobile-delivered personalized ... Anticipated outcomes from this study include advancements in personalized CBT for anxiety disorders, contributing valuable insights into their ...

2. 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7691088/

Standalone Smartphone Cognitive Behavioral Therapy ... Several reviews and meta-analyses reported the efficacy of EMIs for several mental health problems, including depression, anxiety, perceived stress, and eating ...

4. mhealth.jmir.org mhealth.jmir.org/2025/1/e50006

An App-Based Cognitive Behavioral Therapy Program ... The usability test results, assessed using the Mobile App Rating Scale, showed an overall score of 3.88, with scores above the medium level in ...

5. nature.com nature.com/articles/s41591-025-03639-1

Cognitive behavioral therapy skills via a smartphone app ... A smartphone CBT app that implements five representative CBT skills (behavioral activation, cognitive restructuring, problem solving, assertion training and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05699525

Personalized Mobile Cognitive Behavioral Therapy ... This study aims to compare the effectiveness of a standard mobile iPhone cognitive behavioral therapy program to a personalized mobile iPhone cognitive ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8367167/

Self-guided Cognitive Behavioral Therapy Apps for ... This study aims to systematically assess the features, functionality, data security, and congruence with evidence of self-guided CBT-based apps targeting users ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2214782925000065

Efficacy of a process-based, Mobile-delivered personalized ... Internet-based Cognitive Behavioral Therapy (ICBT) is effective in treating anxiety disorders, yet there is room for improvement in treatment response and ...