Mobile Cognitive Behavioral Therapy in Early Stroke Recovery (NCT07639606) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mobile Cognitive Behavioral Therapy in Early Stroke Recovery
United States10 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 79 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 18-79
* 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 eva…
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.
1This trial is testing whether a mobile CBT app called Maya is even feasible and acceptable to use after stroke — it's not yet testing whether it actually improves anxiety or depression — so is a feasibility study the right fit for me given where I am in my recovery right now?
2Since the trial isn't recruiting yet, how long might it realistically be before I could even enroll, and what options are available to address my post-stroke anxiety or depression in the meantime?
3The study measures how many therapy sessions and homework exercises participants complete, which suggests there's a real time and effort commitment — given my current physical and cognitive recovery, is this something my care team thinks I could realistically manage on a phone app?
4Because this is a feasibility study with no assigned phase, it's focused on how the app works in practice rather than proving it helps — should I also be considering standard treatments like in-person CBT or medication for post-stroke depression and anxiety at the same time?
5The trial includes qualitative interviews as part of what's being measured — can you help me understand what that would involve and whether sharing my personal experience as part of a research study feels right for me at this stage?
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
1
Feasibility and Acceptability of Maya as measured by the Mobile Application Rating Scale-User Version (uMARS)
Timeframe: Week 5 of treatment
2
Percent of Sessions completed over study time period
Timeframe: From Week 1 to Week 5 of treatment
3
Percent of homework exercises completed
Timeframe: From Week 1 to Week 5 of treatment
4
Qualitative interview
Timeframe: Week 5 of treatment
Trial details
NCT IDNCT07639606
SponsorWeill Medical College of Cornell University