NCT05754151

Brief Summary

This study aims to assess a mobile iPhone 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Jun 2023Jun 2027

First Submitted

Initial submission to the registry

February 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 16, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

4 years

First QC Date

February 22, 2023

Last Update Submit

June 18, 2025

Conditions

Anxiety Disorders and SymptomsDepressive SymptomsDepression

Keywords

AnxietyCBTMobile ApplicationCognitive Behavioral TherapyDepressionOlder AdultsAdults

Outcome Measures

Primary Outcomes (5)

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

    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

    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

    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

    Total number of sessions completed by the end of the administered intervention

    Week 12 (Follow Up)

Secondary Outcomes (2)

  • Change in anxiety symptoms as measured by the HAM-A

    Baseline, Week 6 (Endpoint), and Week 12 (Follow Up)

  • Change in depressive symptoms as measured by the MADRS

    Baseline, Week 6 (Endpoint), and Week 12 (Follow Up)

Study Arms (1)

MAYA Mobile App

EXPERIMENTAL

Participants receive treatment with the MAYA application for 6 weeks

Behavioral: MAYA Mobile Application

Interventions

MAYA Mobile ApplicationBEHAVIORAL

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.

MAYA Mobile App

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Jennifer Bress, Ph.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maddy Schier

CONTACT

(646) 289-5271mas4019@med.cornell.edu

Zareen Mir

CONTACT

(646)-289-5271zam4005@med.cornell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
All participants will receive the same intervention. Therefore, no masking is required.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 3, 2023

Study Start

June 16, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)