NCT07639606 · Weill Medical College of Cornell University
Mobile Cognitive Behavioral Therapy in Early Stroke Recovery
What this study is about
This study aims to pilot "Maya," a mobile cognitive behavioral therapy app, for use in adults with stroke experiencing depression and/or anxiety. This study will assess the acceptability, feasibility, and preliminary effectiveness of Maya within the acute rehabilitation period.
View original scientific description
This study aims to pilot "Maya," a mobile cognitive behavioral therapy app, for use in adults with stroke experiencing depression and/or anxiety. This study will assess the acceptability, feasibility, and preliminary efficacy of Maya within the acute rehabilitation period.
Interventions
DEVICE
Mobile Cognitive Behavioral Therapy 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 5 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
Percent of Sessions completed over study time period
Time frame: From Week 1 to Week 5 of treatment
Feasibility will be assessed by the percentage of possible sessions completed
Percent of homework exercises completed
Time frame: From Week 1 to Week 5 of treatment
Feasibility will be assessed by the percentage of assigned homework exercises that are completed
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
- Positive screen on the Hospital Anxiety and Depression Scale (HADS), either the HADSD (depression, score \>= 8) and/or HADS-A (anxiety, score \>= 8).
- Stroke that occurred within 1 month prior to study initiation.
- Capacity to provide consent as determined by the UCSD Brief Assessment for Capacity to Consent (UBACC)
- Montreal Cognitive Assessment (MoCA) score greater than or equal to 18, indicating no more than mild cognitive difficulties
- Ability to use iPhone or iPad independently or through the assistance of a caregiver (participants will use their own iPhone if they have one, otherwise they will be loaned an iPad by the study team)
- Able to adhere to all study requirements and willingness to participate in the full study duration
Exclusion criteria
- Aphasia or neglect that would interfere with use of the app, as determined through evaluation by speech-language pathology and occupational therapy conducted as part of standard clinical care
- Non-fluency in English
- History of a major neurologic disorder or of serious mental illness (bipolar or psychotic disorder, alcohol or substance use disorder as assessed through chart review)
- Active suicidal ideation requiring a higher level of care
- Severe depression and/or anxiety based on the initial evaluation and clinical judgment of the PI, which warrants a higher level of care and/or immediate referral to psychiatric services
- Any other clinical or medical reason in the initial 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 Sep 23, 2026 · Source of record for eligibility and locations