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

4 Participants Needed

Trial Summary

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 data supports the idea that Mobile Cognitive Behavioral Therapy for Anxiety and Depression is an effective treatment?

The available research shows that Mobile Cognitive Behavioral Therapy (CBT) is effective for treating anxiety and depression. For example, a study on internet-based CBT programs found that patients with moderate depression experienced a 23% reduction in their depression scores after using the program. Additionally, clinics in several countries reported large improvements in patients' mental health and high satisfaction levels when using internet-delivered CBT. These findings suggest that Mobile CBT can be a valuable tool for managing anxiety and depression, offering a convenient and effective alternative to traditional therapy. ^{1 2 3 4 5}

What safety data exists for mobile CBT for anxiety and depression?

The safety data for mobile cognitive behavioral therapy (CBT) indicates that when CBT is practiced appropriately, the rate of adverse events is as low as or lower than using a pill placebo. Adverse events are often linked to low-quality CBT due to therapists' lack of knowledge, skills, and experience. Effective CBT requires frequent patient assessments and supervision. Mobile CBT has been shown to be effective for anxiety and depression, with studies indicating large effect sizes in both therapist-led and technology-supported settings. ^{1 6 7 8 9}

Is Clinician Delivered CBT a promising treatment for anxiety and depression?

Yes, Clinician Delivered CBT is a promising treatment for anxiety and depression. It is considered the gold standard for treating mental health issues and can be made more accessible through mobile and internet-based platforms, allowing more people to benefit from it. ^{10 11 12 13 14}

What is the purpose of this trial?

This trial tests if adding a mobile app to regular therapy sessions helps young adults with anxiety and depression more than just therapy alone. The app is used to practice therapy exercises, making it easier for patients to manage their symptoms.

Research Team

Patricia Marino

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

I have access to an Apple iPhone.

Exclusion Criteria

Lifetime diagnosis of a bipolar or psychotic disorder

Intent or plan to attempt suicide

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Why Uptake of Blended Internet-Based Interventions for Depression Is Challenging: A Qualitative Study on Therapists' Perspectives. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Clinician-assisted Internet-based treatment is effective for depression: randomized controlled trial. [2022]

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

4. France pubmed.ncbi.nlm.nih.gov

[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. [2018]

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ICBT in routine care: A descriptive analysis of successful clinics in five countries. [2023]

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. Japan pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

CBT for depression: a pilot RCT comparing mobile phone vs. computer. [2022]

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

Moodivate: A self-help behavioral activation mobile app for utilization in primary care-Development and clinical considerations. [2018]

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

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

11. Netherlands pubmed.ncbi.nlm.nih.gov

Video-based CBT-E improves eating patterns in obese patients with eating disorder: A single case multiple baseline study. [2019]

12. England pubmed.ncbi.nlm.nih.gov

The feasibility and effectiveness of Catch It, an innovative CBT smartphone app. [2020]

13. Canada pubmed.ncbi.nlm.nih.gov

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

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

An Internet-Based Cognitive Behavioral Therapy Program for Anxiety and Depression (Tranquility): Adaptation Co-design and Fidelity Evaluation Study. [2022]