Mobile CBT for Anxiety and Depression

Overseen By Zareen Mir

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Bipolar, Psychotic, Recent therapy, others

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

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of a mobile app, called MAYA, to help middle-aged and older adults manage anxiety and depression. The app teaches skills from cognitive behavioral therapy, a type of talk therapy that helps change negative thought patterns. Participants will use the app for about 20 minutes, twice a week, over six weeks, and share their experiences through check-ins and questionnaires. The trial seeks individuals aged 40 or older with anxiety or depression who have access to an iPhone. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mental health support through technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you haven't changed the dose of a psychiatric medication in the past 12 weeks.

What prior data suggests that the MAYA app is safe for use in middle-aged and older adults with anxiety or mood disorders?

Research has shown that the MAYA app, a digital tool for cognitive behavioral therapy (CBT), has been safely used by young adults. Studies have found that this app helps lower anxiety without causing harmful side effects. Participants in earlier research shared positive experiences and noted improvements in managing their anxiety and stress.

One study specifically examined user interaction with the app and found it effective and easy to use. Its simplicity and accessibility enhance safety, as it doesn't involve medication or physical treatments. The app teaches coping skills and strategies, which are generally safe and well-tolerated.

While the current study focuses on middle-aged and older adults, safety data from young adults suggests that the app is likely safe for this new group as well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for anxiety and depression, which typically involve medication or traditional face-to-face therapy, the MAYA Mobile Application delivers cognitive behavioral therapy (CBT) through a smartphone app. This digital approach makes therapy more accessible and convenient, allowing users to engage with therapeutic content anytime and anywhere. Researchers are excited about its potential to reach a wider audience, especially those who may have difficulty accessing in-person therapy, and to provide a cost-effective, scalable solution for managing mental health.

What evidence suggests that the MAYA app is effective for anxiety and depression?

Research has shown that the MAYA app, which incorporates techniques from cognitive behavioral therapy (CBT), helps reduce anxiety. In earlier studies, young adults who used the app experienced a noticeable drop in anxiety after six weeks. Initial results also suggest that the app can be adjusted for middle-aged and older adults, making it suitable and practical for them as well. In this trial, participants will use the MAYA application for six weeks. The app teaches users how to cope with anxiety and depression and has shown promise for those dealing with these issues. Overall, the app appears to be a useful tool for lowering anxiety symptoms. ^{1 2 5 6 7}

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 middle-aged and older adults, aged 40 or above, who have been diagnosed with anxiety or depression. They must score at least a 4 on the ADIS scale and perform within normal range on a mental status exam. People can't join if they've started psychotherapy recently, plan to harm themselves, changed psychiatric meds in the last 3 months, or have a history of bipolar or psychotic disorders.

Inclusion Criteria

My mental function test score is within the normal range for my age and education.

Access to an Apple iPhone

I am 40 years old or older.

Exclusion Criteria

Lifetime diagnosis of a bipolar or psychotic disorder

I am currently undergoing cognitive behavior therapy.

I haven't changed my psychiatric medication dose 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 at least two days a week, 20 minutes each day, for six weeks

6 weeks

Weekly check-ins (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Assessments at week 12

What Are the Treatments Tested in This Trial?

Interventions

• MAYA Mobile Application

Trial Overview The study tests the MAYA mobile app designed to help manage anxiety and depression through cognitive behavioral therapy techniques. Participants will use it twice weekly for six weeks and attend check-ins to assess their progress and how they feel about the app.

How Is the Trial Designed?

Group I: MAYA Mobile App Experimental Treatment 1 Intervention

Participants receive treatment with the MAYA application for 6 weeks

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Joseph S. Sanchez Foundation

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

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]

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 developed a protocol for evaluating the effectiveness of cell phone-supported cognitive behavioral therapy (CBT) for managing anxiety disorders in real-world clinical settings, addressing the limitations of traditional randomized controlled trials.

Key aspects of the protocol include analyzing therapist roles and ensuring adherence to treatment, which will help identify effective CBT methods that can be integrated into health services more broadly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell phone-supported cognitive behavioural therapy for anxiety disorders: a protocol for effectiveness studies in frontline settings. Ekberg, J., Timpka, T., Bång, M., et al.[2021]

In a study of 96 clients undergoing internet-delivered cognitive behaviour therapy (ICBT), 61.5% reported experiencing at least one negative effect during treatment, highlighting the importance of monitoring these effects in real-time rather than relying solely on post-treatment reports.

Common negative effects included technical difficulties and negative emotional states, but serious adverse events like symptom deterioration were not reported, suggesting that while ICBT is generally effective, there are still challenges that need to be addressed to improve client experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative effects associated with internet-delivered cognitive behaviour therapy: An analysis of client emails. Gullickson, KM., Hadjistavropoulos, HD., Dear, BF., et al.[2020]

A review of 27 popular mental health apps for depression and anxiety revealed that while 23 apps included evidence-based therapeutic elements, many core components of effective psychotherapy, such as cognitive restructuring and problem solving, were significantly underrepresented.

Common elements like psychoeducation, relaxation, and mindfulness were present in many apps, but the lack of critical treatment strategies suggests a need for further research and randomized trials to evaluate the effectiveness of these apps in delivering comprehensive mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of popular smartphone apps for depression and anxiety: Assessing the inclusion of evidence-based content. Wasil, AR., Venturo-Conerly, KE., Shingleton, RM., et al.[2020]

A smartphone-based digital CBT intervention called 'Daylight™' was found to be feasible and safe for treating Generalized Anxiety Disorder (GAD) in a study of 21 adults, with high engagement and satisfaction reported by participants.

The intervention showed promising efficacy, with 70% of participants no longer experiencing clinically significant GAD symptoms and significant reductions in depressive symptoms and sleep difficulties after the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study. Miller, CB., Gu, J., Henry, AL., 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]

A randomized controlled trial with 30 military personnel showed that using a mobile health (mHealth) application alongside cognitive behavioral therapy (CBT) significantly improved compliance and reduced symptoms of depression, anxiety, stress, and anger compared to traditional CBT alone, where 50% of participants dropped out.

The study highlights the potential of integrating data-driven mobile applications with mental health treatments to enhance therapy adherence in high-risk populations like military personnel, paving the way for more personalized and effective mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated stress detection using mobile application and wearable sensors improves symptoms of mental health disorders in military personnel. Winslow, BD., Kwasinski, R., Hullfish, J., et al.[2022]

Mobile phone-based psychotherapies, including apps and text messages, are feasible and generally acceptable for treating various mental health disorders, as shown by a review of 24 studies with good retention rates.

While these interventions show potential benefits for mental health outcomes, the evidence on their effectiveness in real-world settings is still limited, particularly in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapeutic Applications of Mobile Phone-based Technologies: A Systematic Review of Current Research and Trends. Menon, V., Rajan, TM., Sarkar, S.[2022]

Citations

1. 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 ...

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

Efficacy of a Mobile App-Based Intervention for Young ... However, after 6 weeks of use of the app, there was a clinically and statistically significant decrease in anxiety symptoms across conditions.

3. news.weill.cornell.edu news.weill.cornell.edu/news/2024/08/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. healio.com healio.com/news/psychiatry/20250825/qa-maya-app-addresses-traditional-barriers-for-young-adults-with-anxiety

Q&A: 'Maya' app addresses traditional barriers for young ... Young adults with anxiety showed greater symptom improvement after utilizing a self-guided, mobile cognitive behavioral therapy app, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S106474812400229X

Adaptation of a Self-Guided Cognitive Behavioral Therapy ... These preliminary findings suggest that Maya, when modified for middle-aged and older adults with anxiety or depression, may be acceptable and feasible for use ...

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

Maya App for Stress Management This N/A medical study run by University of Michigan is evaluating whether Maya App will have tolerable side effects & efficacy for patients with Mental ...