What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) is a common treatment for anxiety disorders and is generally well-tolerated with minimal side effects. Some patients may experience temporary increases in anxiety or emotional discomfort as they confront their fears and anxieties during therapy sessions. Pharmacological treatments for anxiety disorders, such as SSRIs (Selective Serotonin Reuptake Inhibitors) and benzodiazepines, can have side effects including nausea, insomnia, dizziness, weight gain, and, in the case of benzodiazepines, potential for dependence and withdrawal symptoms. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

Between 1985 and 2000, the FDA approved several drugs for the treatment of anxiety disorders, including 13 anxiolytics evaluated in 40 clinical trials. Common pharmacotherapies for anxiety disorders include Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), which are often preferred due to their efficacy and safety profile. Cognitive Behavioral Therapy (CBT) is also a widely recommended treatment, either alone or in combination with pharmacotherapy, for managing anxiety disorders. The MAYA app trial focuses on CBT-based coping skills, which align with the broader therapeutic approach of combining medication with CBT to enhance treatment outcomes.

What other types of research exist?

Promising alternatives to the MAYA app for treating anxiety disorders include: 1) Self-guided virtual reality-based CBT apps, which have shown efficacy in treating panic disorder and acrophobia. 2) Digital CBT for Insomnia (CBT-I), which has demonstrated improvements in psychological well-being and sleep-related quality of life. 3) Psilocybin-assisted psychotherapy, which has shown potential in reducing psychiatric and existential distress in patients with life-threatening conditions. These alternatives offer innovative and effective approaches to managing anxiety disorders.

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Cognitive Behavioral Therapy

Mobile CBT for Anxiety and Depression

N/A

Recruiting

Led By Jennifer Bress, Ph.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 6 (endpoint), and week 12 (follow up)

Awards & highlights

Study Summary

This trial assesses a mobile app designed to help middle-aged & older adults manage anxiety & depression. Participants use the app for 6 weeks & are assessed at the start, middle, & end of the study. The app's success is measured by usage & symptom reduction.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves using an educational mobile application rather than medication, traditional side effects are not expected. However, users may experience discomfort if confronting challenging emotions during therapy sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 6 (endpoint), and week 12 (follow up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 6 (endpoint), and week 12 (follow up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6 (endpoint), and week 12 (follow up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of the MAYA application as measured by mean uMARS scores at Baseline

Acceptability of the MAYA application as measured by mean uMARS scores at Endpoint

Acceptability of the MAYA application as measured by mean uMARS scores at Midpoint

+2 more

Secondary outcome measures

Change in anxiety symptoms as measured by the HAM-A

Change in depressive symptoms as measured by the MADRS

Trial Design

1Treatment groups

Experimental Treatment

Group I: MAYA Mobile AppExperimental Treatment1 Intervention

Participants receive treatment with the MAYA application for 6 weeks

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy (CBT) is a common treatment for anxiety disorders that works by helping patients identify and challenge negative thought patterns and behaviors, replacing them with more positive and realistic ones. This process involves cognitive restructuring, where patients learn to reframe their thoughts, and behavioral activation, where they engage in activities that reduce anxiety. Mindfulness-based techniques, often integrated into CBT, teach patients to focus on the present moment and accept their thoughts without judgment. Understanding these mechanisms is crucial for patients as it empowers them to actively participate in their treatment, leading to better management of their anxiety symptoms and improved overall well-being.

Problem-Focused Psychodynamic Psychotherapies.

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Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,060 Previous Clinical Trials

1,316,153 Total Patients Enrolled

16 Trials studying Anxiety Disorders

971 Patients Enrolled for Anxiety Disorders

Jennifer Bress, Ph.D.Principal InvestigatorWeill Medical College of Cornell University

1 Previous Clinical Trials

100 Total Patients Enrolled

1 Trials studying Anxiety Disorders

100 Patients Enrolled for Anxiety Disorders

Media Library

MAYA Mobile Application (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05754151 — N/A

Anxiety Disorders Research Study Groups: MAYA Mobile App

Anxiety Disorders Clinical Trial 2023: MAYA Mobile Application Highlights & Side Effects. Trial Name: NCT05754151 — N/A

MAYA Mobile Application (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05754151 — N/A

~5 spots leftby Jun 2025

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