Recruiting
Mobile Cognitive Behavioral Therapy in Early Stroke Recovery
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.
ClinicalTrials.gov IDNCT07639606
PhaseNA
Enrollment10
SponsorWeill Medical College of Cornell University
Age18 Years
SexALL
Conditions studied
Anxiety, Stroke, Depression - Major Depressive Disorder
About this study
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 outcomes
- Feasibility and Acceptability of Maya as measured by the Mobile Application Rating Scale-User Version (uMARS) (Week 5 of treatment)
- Percent of Sessions completed over study time period (From Week 1 to Week 5 of treatment)
- Percent of homework exercises completed (From Week 1 to Week 5 of treatment)
Eligibility information
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 evaluation that suggests the study is not appropriate for the participant
Study locations
- Weill Cornell Medicine, New York, New York 10065 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.