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Recruiting
NCT07639606
Mobile Cognitive Behavioral Therapy in Early Stroke Recovery
Conditions: Anxiety, Stroke, Depression - Major Depressive Disorder
Sex: All
Ages: 18 Years – 79 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Weill Medical College of Cornell University
Location: Weill Cornell Medicine New York New York
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07639606). StuddyBuddy aggregates publicly available trial information.