NCT06689878 · Weill Medical College of Cornell University
Mobile Cognitive Behavioral Therapy for Stroke
What this study is about
This study aims to assess the feasibility and acceptability of "MAYA", a mobile cognitive behavioral therapy app for anxiety and mood disorders, in adults who have had a stroke.
View original scientific description
This study aims to assess the feasibility and acceptability of "MAYA", a mobile cognitive behavioral therapy app for anxiety and mood disorders, in adults who have had a stroke.
Interventions
BEHAVIORAL
Mobile Cognitive Behavioral App
A mobile cognitive behavioral therapy (CBT) app called "Maya" that includes modules with educational content and teaching and practice of strategies that address depression and anxiety after stroke.
Primary outcome measures
Feasibility and Acceptability of MAYA as measured by the Mobile Application Rating Scale-User Version (uMARS)
Time frame: Week 4 of treatment
Feasibility and acceptability will be measured by the scores collected on the uMARS by assessing the sub scores of Engagement, Functionality, Aesthetics, and Information of the app to measure the perceived quality of the app. The outcome is the mean of the individual items, ranging from 1 to 5, with 1 denoting minimal satisfaction/rating of app quality and 5 denoting maximum satisfaction and highest rating of app quality.
Feasibility and Acceptability of MAYA as measured by the Mobile Application Rating Scale-User Version (uMARS)
Time frame: Week 8 of treatment
Feasibility and acceptability will be measured by the scores collected on the uMARS by assessing the sub scores of Engagement, Functionality, Aesthetics, and Information of the app to measure the perceived quality of the app. The outcome is the mean of the individual items, ranging from 1 to 5, with 1 denoting minimal satisfaction/rating of app quality and 5 denoting maximum satisfaction and highest rating of app quality.
Number of Sessions completed over study time period
Time frame: Week 1 to Week 8 (8 week treatment)
To assess the feasibility of "MAYA" in adults who have had a stroke, by assessing the number of sessions completed.
Qualitative Interview
Time frame: Week 8 of treatment
This is a series of questions with open-ended responses that are designed to ask participants about their experience using the app and completing the CBT program. There is no numerical scoring; responses are evaluated qualitatively to explore engagement with the app.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Presence of clinically-significant anxiety and/or depression (as determined by an eligibility evaluation)
- Stroke that occurred 1 month or more prior to study initiation
- Capacity to provide consent
- No greater than mild cognitive difficulties based on an eligibility evaluation conducted as part of the study
- If taking medication for depression and/or anxiety, must be on a stable dose for a minimum of 8 weeks prior to study initiation
- Ability to use iPhone or iPad independently
- Home internet access
- Willingness to participate in the full study duration.
Exclusion criteria
- Aphasia of moderate or greater severity (as determined during an eligibility evaluation)
- Non-fluency in English
- History of a bipolar or psychotic disorder
- Current alcohol or substance use disorder
- Active suicidal ideation
- Current engagement in psychotherapy is not grounds for exclusion unless the individual's psychotherapy is primarily focused on CBT
- Severe depression and/or anxiety based on the initial evaluation and clinical judgment of the study doctor, which warrants a higher level of care and/or immediate referral to psychiatric services
- Any other clinical or medical reason in the study doctor's initial screening evaluation that suggests the study is not appropriate for the participant
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations