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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07639606). StuddyBuddy aggregates publicly available trial information.