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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Joseph S. Sanchez Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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