Mobile Cognitive Behavioral Therapy for Anxiety and Depression

Overseen By Patricia Marino, Ph.D

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Bipolar, Psychotic disorder, Suicide intent

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding a mobile app called "MAYA" to regular therapy sessions can better assist people with anxiety and depression. Participants will use the app alongside standard therapy twice a week for six weeks. Researchers believe that combining the app with therapy will lead to greater improvements than therapy alone. Ideal participants are graduate students at Weill Cornell Medicine who have significant anxiety or depression and own an Apple iPhone. As an unphased trial, this study provides participants the chance to explore innovative treatment methods that could enhance their mental health outcomes.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the MAYA app is safe for use in cognitive behavioral therapy?

Research has shown that mobile apps for cognitive behavioral therapy (CBT) are generally safe for treating anxiety and mood disorders. One study examined a similar app called MAYA, used by middle-aged and older adults, and found it acceptable with no major safety issues reported. Another study demonstrated that mobile CBT apps can effectively reduce anxiety symptoms. Although many apps lack detailed safety information, existing research suggests they are usually well-tolerated.

In this trial, participants will use the MAYA app alongside traditional CBT. Previous research indicates that using the app should be safe for most people. However, individual experiences may vary, so discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for anxiety and depression, like traditional Cognitive Behavioral Therapy (CBT), involve regular sessions with a therapist. However, researchers are excited about the combination of clinician-delivered CBT with a mobile app because it offers a flexible and accessible way to enhance treatment. This app allows participants to engage with therapeutic exercises at least twice a week for six weeks, providing continuous support outside of therapy sessions. This hybrid approach could make therapy more effective by reinforcing skills learned during sessions and offering help anytime, anywhere.

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

Research has shown that using a mobile app for cognitive behavioral therapy (CBT), such as "MAYA," can help reduce symptoms of anxiety and depression. In this trial, one group of participants will receive clinician-delivered CBT along with the supplemental MAYA app. One study found that young adults using a mobile CBT app experienced less anxiety, indicating that combining the app with traditional CBT might be beneficial. Another study found that app-based CBT helped prevent major depression and improved sleep problems in young people. These findings suggest that the MAYA app could enhance therapist-led CBT by providing additional support and strategies. ^{1 6 7 8 9}

Who Is on the Research Team?

Patricia Marino

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for medical and graduate students aged 18-40 at Weill Cornell Medicine who are experiencing significant anxiety or depression, as indicated by specific scores on recognized scales. It's not open to those with a history of bipolar or psychotic disorders, or current severe suicidal intentions.

Inclusion Criteria

I have access to an Apple iPhone.

Clinically significant anxiety (as determined by a score of 10 or greater on the GAD-7) or clinically significant depression (as determined by a score of 10 or greater on the PHQ-9)

Current graduate student at Weill Cornell Medicine

Exclusion Criteria

Lifetime diagnosis of a bipolar or psychotic disorder

Intent or plan to attempt suicide

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive clinician-delivered CBT, with the intervention group also using a mobile app for at least 20 minutes two times per week for six weeks

6 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for changes in depressive and anxiety symptoms after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinician Delivered CBT
• Supplemental MAYA App

Trial Overview The study compares two approaches: standard clinician-delivered cognitive behavioral therapy (CBT) versus CBT with the addition of 'MAYA', a mobile app designed to support mental health. Participants will use MAYA twice weekly alongside regular CBT sessions and complete weekly self-assessments.

How Is the Trial Designed?

Group I: Clinician-delivered CBT + Supplemental app Experimental Treatment 2 Interventions

Mobile application at least two times per week for six weeks, for at least 20 minutes on each of the two days in addition to the clinician-delivered CBT

Group II: Clinician-delivered Cognitive Behavioral Therapy only Active Control 1 Intervention

Participants receive treatment with a licensed clinician for 6 weeks.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

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]

When cognitive behavioral therapy (CBT) is conducted effectively, the rate of adverse events is very low, comparable to or even lower than that of a placebo, indicating its safety and efficacy.

Many adverse events arise from poor-quality CBT due to therapists' insufficient training, highlighting the importance of regular patient assessments and supervision to ensure high standards in therapy delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. Okmaoto, Y., Jinnin, R., Yoshino, A., et al.[2018]

A pilot study with 35 participants suffering from Major Depression showed that both mobile app and computer-based delivery of a cognitive behavioral therapy program led to significant improvements in depression symptoms, as measured by the PHQ-9 scale.

The benefits of the therapy were maintained at a 3-month follow-up, indicating that mobile delivery of the CBT program is an effective option for treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CBT for depression: a pilot RCT comparing mobile phone vs. computer. Watts, S., Mackenzie, A., Thomas, C., et al.[2022]

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]

The Internet-based clinician-assisted computerized cognitive behavioral treatment (CaCCBT) program significantly reduced depression symptoms in 45 participants, with a high completion rate of 74% over 8 weeks.

Participants reported a strong satisfaction with the program, and the treatment showed large effect sizes (Cohen's d of 0.98 and 0.75), indicating its efficacy in improving mental health outcomes compared to a waitlist control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician-assisted Internet-based treatment is effective for depression: randomized controlled trial. Perini, S., Titov, N., Andrews, G.[2022]

Internet delivered cognitive behaviour therapy (ICBT) has been shown to be effective for treating anxiety and depression, with large clinical improvements and high patient satisfaction reported across clinics in Sweden, Denmark, Norway, Canada, and Australia.

ICBT services, which include therapist support and rigorous governance for quality and safety, can reach more patients, especially those in remote areas, compared to traditional face-to-face assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ICBT in routine care: A descriptive analysis of successful clinics in five countries. Titov, N., Dear, B., Nielssen, O., et al.[2023]

Mobile video-based Cognitive Behavioral Therapy (CBT) significantly increased daily meal frequency in patients with eating disorders, demonstrating a medium to large effect size (NAP = 0.89) based on a study involving five participants.

Participants reported high satisfaction with the mobile video application for therapy, indicating that this method can effectively reach patients with limited access to traditional mental health services, despite some technical issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-based CBT-E improves eating patterns in obese patients with eating disorder: A single case multiple baseline study. Abrahamsson, N., Ahlund, L., Ahrin, E., et al.[2019]

The iCBT program Tranquility demonstrated a high fidelity to cognitive behavioral therapy principles, with a mean rating of 91% from CBT experts, indicating it effectively follows established therapeutic guidelines.

Usability ratings for Tranquility were also high, with 88% of participants recommending the program, suggesting it is user-friendly and has potential for broader adoption in treating anxiety and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Cognitive Behavioral Therapy Program for Anxiety and Depression (Tranquility): Adaptation Co-design and Fidelity Evaluation Study. Patterson, VC., Rossi, MA., Pencer, A., et al.[2022]

Therapists generally found blended cognitive behavioral therapy (bCBT) to be usable and satisfying, indicating a positive reception towards integrating it into routine practice for treating depression.

Despite the potential benefits of bCBT, therapists reported not experiencing the expected time savings and identified several challenges that need to be addressed to enhance its adoption and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why Uptake of Blended Internet-Based Interventions for Depression Is Challenging: A Qualitative Study on Therapists' Perspectives. Mol, M., van Genugten, C., Dozeman, E., et al.[2020]

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]

Computer-delivered Cognitive Behavioral Therapies (C-CBT) are effective for treating depression, showing high effectiveness and adherence among self-referred individuals, based on a review of 22 randomized controlled studies.

Therapist support significantly enhances the effectiveness and adherence of C-CBT, particularly for outpatients referred by clinicians, highlighting the importance of integrating some level of guidance in these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. Iakimova, G., Dimitrova, S., Burté, T.[2018]

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]

Depressive symptoms are common and can lead to significant impairment, making effective treatment in primary care essential, yet access to evidence-based psychotherapy remains limited due to various barriers.

The Moodivate mobile application was developed to deliver the Behavioral Activation Treatment for Depression (BATD) through primary care, aiming to improve access to effective treatment and is currently being evaluated in a clinical trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moodivate: A self-help behavioral activation mobile app for utilization in primary care-Development and clinical considerations. Dahne, J., Lejuez, CW., Kustanowitz, J., et al.[2018]

The Catch It smartphone app, designed for cognitive-behavioral therapy (CBT), showed that 84% of user-generated content aligned with CBT principles, indicating good fidelity to the therapy's concepts.

Users of the app experienced statistically significant reductions in negative mood intensity and increases in positive mood intensity, suggesting that the app can have beneficial effects on mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and effectiveness of Catch It, an innovative CBT smartphone app. Kinderman, P., Hagan, P., King, S., et al.[2020]

Citations

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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. 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.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837059

Cognitive Behavioral Therapy App, Functional Connectivity ... We recently showed that use of a mobile CBT app (Maya) was associated with reductions in anxiety symptoms in young adults. However, only 50% to ...

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

Adaptation of a Self-Guided Cognitive Behavioral Therapy ... We adapted Maya for middle-aged and older adults with anxiety or depression by modifying language and examples throughout the app to be more relevant to the ...

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Effectiveness of app-based cognitive behavioral therapy for ... Conclusions: App-based CBT-I is effective in preventing future onset of major depression and improving insomnia outcomes among youth with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11127134/

Feasibility and Acceptability of a Mobile App–Based TEAM ... This study is the first reported proof-of-concept evaluation of the Feeling Good App in terms of safety, feasibility, and statistical trends within the data ...

7. withpower.com withpower.com/trial/phase-disease-2023-9a719

Mobile Cognitive Behavioral Therapy App for Anxiety and ... The safety of mobile apps for anxiety and PTSD, which often use cognitive behavioral therapy techniques, is generally considered acceptable, but many apps lack ...

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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.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05823922

Study Details | Mobile Cognitive Behavioral Therapy for ... The study aims to assess and compare clinician-delivered cognitive behavior therapy (CBT) supplemented with "MAYA", a mobile cognitive behavioral therapy app ...