RecruitingNot Applicable

Mobile CBT for Middle Aged and Older Adults

United States60 participantsStarted 2023-06-16

Plain-language summary

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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Week 1 (Baseline)

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

Timeframe: Week 3 (Midpoint)

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

Timeframe: Week 6 (Endpoint)

Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Endpoint

Timeframe: Week 6 (Endpoint)

Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Follow Up

Timeframe: Week 12 (Follow Up)

Trial details

NCT IDNCT05754151

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Maddy Schier

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

View on ClinicalTrials.gov More Anxiety Disorders and Symptoms trials

Plain-language summary

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Week 1 (Baseline)

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

Timeframe: Week 3 (Midpoint)

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

Timeframe: Week 6 (Endpoint)

Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Endpoint

Timeframe: Week 6 (Endpoint)

Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Follow Up

Timeframe: Week 12 (Follow Up)