Recruiting

Maya

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07639606

Conditions

Anxiety

Stroke

Depression - Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mobile Cognitive Behavioral Therapy App

Study Details

Brief 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.

Conditions

Anxiety

Stroke

Depression - Major Depressive Disorder

Study ID

NCT07639606

Start date

Nov, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Arm Using the Mobile Cognitive Behavioral Therapy App

The intervention used in the present study is an adapted version of Maya, a cognitive behavioral therapy (CBT) mobile application. The app includes modules with educational content and practice of strategies that address post-stroke depression, anxiety, and emotional difficulties.

Interventions

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 measure

  • Feasibility and Acceptability of Maya as measured by the Mobile Application Rating Scale-User Version (uMARS) [ Time Frame: Week 5 of treatment ]
  • Percent of Sessions completed over study time period [ Time Frame: From Week 1 to Week 5 of treatment ]
  • Percent of homework exercises completed [ Time Frame: From Week 1 to Week 5 of treatment ]

Central Contacts and Locations

Central contacts

Abhishek Jaywant, PhD

212-746-4666abj2006@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Abhishek Jaywant, PhD

212-746-4666abj2006@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

  • stroke recovery
  • stroke rehabilitation
  • cognitive behavioral therapy
  • CBT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.