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

Trial Summary

What is the purpose of this trial?

This trial tests a mobile app called MAYA that helps middle-aged and older adults with anxiety or depression. The app teaches coping skills from cognitive behavioral therapy. Participants will use the app regularly over several weeks. The study aims to see if the app is easy to use and effective in reducing symptoms.

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 data supports the effectiveness of the MAYA Mobile Application treatment for anxiety and depression?

Research shows that smartphone apps based on cognitive behavioral therapy (CBT) principles, like the MAYA Mobile Application, are considered effective for treating mental health issues, including anxiety and depression. Studies have found that these mobile-based therapies are feasible, acceptable, and can improve mental health outcomes, although more research is needed to confirm their effectiveness in real-world settings. ^{1 2 3 4 5}

Is mobile CBT safe for treating anxiety and depression?

Mobile CBT is generally safe, but some users may experience negative effects like technical issues, implementation problems, or negative emotions. Serious adverse events were not reported in the studies reviewed. ^{6 7 8 9 10}

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

The MAYA Mobile Application offers a unique approach by providing cognitive behavioral therapy (CBT) through a mobile app, allowing users to practice skills and manage symptoms in real-time and in their everyday environment. This mobile format can enhance traditional CBT by using multimedia to help users record and communicate their experiences, potentially leading to better engagement and outcomes compared to standard in-person therapy sessions. ^{11 12 13 14 15}

Research Team

Jennifer Bress, Ph.D.

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

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

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

Psychotherapeutic Applications of Mobile Phone-based Technologies: A Systematic Review of Current Research and Trends. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Smartphone-assisted online brief cognitive behavioral therapy to treat maternal depression: findings of a randomized controlled trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A review of popular smartphone apps for depression and anxiety: Assessing the inclusion of evidence-based content. [2020]

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

Examining the temporal dynamics of anxiety and depressive symptoms during a therapist-supported, smartphone-based intervention for depression: Longitudinal observational study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Cell phone-supported cognitive behavioural therapy for anxiety disorders: a protocol for effectiveness studies in frontline settings. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Negative effects associated with internet-delivered cognitive behaviour therapy: An analysis of client emails. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Automated stress detection using mobile application and wearable sensors improves symptoms of mental health disorders in military personnel. [2022]

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

Computer-Assisted Cognitive-Behavior Therapy and Mobile Apps for Depression and Anxiety. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study. [2021]

11. 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]

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

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

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

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

14. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Phone-Based App for Use During Cognitive Behavioral Therapy for Adolescents With Anxiety (MindClimb): User-Centered Design and Usability Study. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Introduction to the Special Issue: Integration of Technological Advances in Cognitive-Behavior Therapy. [2019]