Mobile Cognitive Behavioral Therapy App for Anxiety and Depression

Recruiting in New York (>99 mi)

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 compares two versions of a therapy app for young people with anxiety, depression, or bipolar disorder. One version is personalized to the user's symptoms, while the other is more general. The app teaches new ways to think and act to help improve mental health.

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.

Is the Mobile Cognitive Behavioral Therapy App for Anxiety and Depression safe for humans?

The safety of mobile apps for anxiety and PTSD, which often use cognitive behavioral therapy techniques, is generally considered acceptable, but many apps lack scientific evaluation and strong data protection measures. ^{1 2 3 4 5}

How is the General MAYA Mobile App treatment for anxiety and depression different from other treatments?

The General MAYA Mobile App offers a unique approach by providing personalized cognitive behavioral therapy (CBT) directly through a mobile app, allowing users to engage with therapy in real-time and in their own environment. This contrasts with traditional CBT, which typically requires in-person sessions, and addresses accessibility and convenience issues by enabling users to manage their mental health on-the-go. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment General MAYA Mobile App for anxiety and depression?

Research shows that smartphone apps using cognitive behavioral therapy (CBT) principles, like the General MAYA Mobile App, can effectively reduce symptoms of depression and anxiety. Studies have found that digital CBT tools can improve mental health outcomes and increase patient engagement, making them a promising option for managing these conditions. ^{6 9 10 11 12}

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

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

Current hypomanic or manic episode

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

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]

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]

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]

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]

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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. [2021]

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

Evaluating Commercially Available Mobile Apps for Depression Self-Management. [2022]

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

Enhancing Problem-Solving Therapy With Smartphone Technology: A Pilot Randomized Controlled Trial. [2022]

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

A Gamified Smartphone-Based Intervention for Depression: Randomized Controlled Pilot Trial. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

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

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

Mobile Apps for Post Traumatic Stress Disorder. [2020]

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

Anxiety: There is an app for that. A systematic review of anxiety apps. [2022]

8. 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]

9. 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]

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

Patient and therapist experiences of using a smartphone application monitoring anxiety symptoms. [2022]

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

A Systematic Review of Cognitive Behavioral Therapy and Behavioral Activation Apps for Depression. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile phone computing for in-situ cognitive behavioral therapy. [2018]