Mobile CBT for Middle Aged and Older Adults

May 19, 2026 updated by: Weill Medical College of Cornell University

Feasibility and Acceptability of a Mobile Cognitive Behavior Therapy App Targeting Depression and Anxiety in Older Adults

This study aims to assess a mobile app called MAYA for use in middle-aged and older adults with anxiety or mood disorders. The MAYA app is designed to teach coping skills for anxiety and depression that are drawn from cognitive behavioral therapy. Participants will be asked to use the app for at least two days a week, 20 minutes on each day, for six weeks. Participants will have weekly check-ins as well as longer assessments at the beginning of the study, week 3, week 6 (end of treatment), and week 12 (follow up). During assessments, participants will answer brief questionnaires designed to assess their symptoms and impressions of the app. The main hypotheses of the study are that participants will complete most of the assigned sessions and that they will rate their impressions of the app highly. The secondary hypotheses are that symptoms of depression and anxiety will decrease with use of the MAYA app.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There is a growing need for accessible, affordable, research-supported treatments designed for older adults. Older adults face challenges that limit their ability to physically access mental health services; thus, mobile app-based interventions may be particularly appealing to individuals in this age range with anxiety or depression who are unable to access more traditional psychotherapy administered in person by a therapist. Mobile technology has been used previously to deliver mental health services for adults with a variety of psychiatric symptoms (Dennis & O'Toole, 2014).

Anxiety frequently co-occurs with depression, with 72% of individuals with anxiety having experienced a history of depression (Moffitt et al., 2007). Current models conceptualize anxiety and depression as a confluence of three broad symptom categories - physiological hyperarousal, low positive affect, and high negative affect (Clark & Watson, 1991) - that are present to different degrees in different individuals.

This study aims to assess the acceptability, feasibility and efficacy of "MAYA", a mobile cognitive behavioral therapy app for anxiety and mood disorders, in middle aged and older adults. This study will collect pilot data over the course of 12 weeks. As this is a pilot study, all participants will use the same version of the app and there will be no control group. Participants will be asked to use the mobile app for at least two days a week, for at least 20 minutes on each day, for 6 weeks. Participants will have weekly check-ins in person or via a HIPAA-compliant virtual meeting platform (e.g., Zoom) to assess intervention adherence and answer brief questionnaires designed to assess feasibility, acceptability, and mood symptoms at baseline, week 3, week 6 (end of treatment), and week 12 (follow up). Participants can complete optional recordings of electrical brain activity (electroencephalography, or EEG) at baseline and week 6.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
        • Principal Investigator:
          • Jennifer Bress, Ph.D
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 40 or older
  • Primary diagnosis of an anxiety or depressive disorder as determined by a clinical severity rating score of 4 or greater on the Anxiety Disorders Interview Schedule (ADIS).
  • Mini Mental Status Exam (MMSE) no more than 1 SD below the mean score for patient's age and education. If the remote version of the MMSE is used (e.g. during an evaluation on Zoom), the remote MMSE score will be converted to a standard MMSE score.
  • Access to an Apple iPhone, iPad, or Android device.

Exclusion Criteria:

  • Lifetime diagnosis of a bipolar or psychotic disorder.
  • Currently in cognitive behavior therapy.
  • Change in dose of a psychiatric medication in the past 12 weeks.
  • Initiation of psychotherapy in the past 12 weeks.
  • Intent or plan to attempt suicide.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MAYA Mobile App
Participants receive treatment with the MAYA application for 6 weeks
Behavioral: MAYA Mobile Application
The mobile cognitive behavioral therapy (CBT) application, MAYA, teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, exposure and psychoeducation (i.e. information about anxiety and depression). The application includes an interactive dashboard to provide the user with statistics for tracking progress toward their goals. Although the MAYA application is new, its content and structure are similar to how CBT- a well-established and widely used psychosocial intervention - is commonly delivered in the more traditional setting of a psychotherapist's office.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the MAYA application as measured by mean uMARS scores at Baseline
Time Frame: Week 1 (Baseline)
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Week 1 (Baseline)
Acceptability of the MAYA application as measured by mean uMARS scores at Midpoint
Time Frame: Week 3 (Midpoint)
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Week 3 (Midpoint)
Acceptability of the MAYA application as measured by mean uMARS scores at Endpoint
Time Frame: Week 6 (Endpoint)
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Week 6 (Endpoint)
Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Endpoint
Time Frame: Week 6 (Endpoint)
Total number of sessions completed by the end of the administered intervention
Week 6 (Endpoint)
Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Follow Up
Time Frame: Week 12 (Follow Up)
Total number of sessions completed by the end of the administered intervention
Week 12 (Follow Up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive symptoms as measured by the MADRS
Time Frame: Baseline, Week 6 (Endpoint), and Week 12 (Follow Up)
Depression will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS is a 10-item questionnaire measuring the severity of depression symptoms. Scores range from 0 to 60, where higher scores indicate higher severity of depressive symptoms.
Baseline, Week 6 (Endpoint), and Week 12 (Follow Up)
Change in anxiety symptoms as measured by the HAM-A
Time Frame: Baseline, Week 6 (Endpoint), and Week 12 (Follow Up)
The primary symptom measure for anxiety will be the Hamilton Rating Scale for Anxiety (HAM-A). The HAM-A is a 14-item questionnaire measure of the severity of anxiety symptoms. The items measure both psychic anxiety and somatic anxiety. The scores range from 0 to 56, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.
Baseline, Week 6 (Endpoint), and Week 12 (Follow Up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Joseph S. Sanchez Foundation

Investigators

  • Principal Investigator: Jennifer Bress, Ph.D., Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-01025548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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