Mobile Cognitive Behavioral Therapy for Stroke

Last updated: July 31, 2026
Sponsor: Weill Medical College of Cornell University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Stroke

Cerebral Ischemia

Treatment

Mobile Cognitive Behavioral App

Mobile CBT for Stroke

Clinical Study ID

NCT06689878
24-04027396
  • Ages 40-79
  • All Genders

Study Summary

This study aims to assess the feasibility and acceptability of "MAYA", a mobile cognitive behavioral therapy app for anxiety and mood disorders, in adults who have had a stroke.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 40-79

  • Presence of clinically-significant anxiety and/or depression (as determined by aneligibility evaluation)

  • Stroke that occurred 1 month or more prior to study initiation

  • Capacity to provide consent

  • No greater than mild cognitive difficulties based on an eligibility evaluationconducted as part of the study

  • If taking medication for depression and/or anxiety, must be on a stable dose for aminimum of 8 weeks prior to study initiation

  • Ability to use iPhone or iPad independently

  • Home internet access

  • Willingness to participate in the full study duration.

Exclusion

Exclusion Criteria:

  • Aphasia of moderate or greater severity (as determined during an eligibilityevaluation)

  • Non-fluency in English

  • History of a bipolar or psychotic disorder

  • Current alcohol or substance use disorder

  • Active suicidal ideation

  • Current engagement in psychotherapy is not grounds for exclusion unless theindividual's psychotherapy is primarily focused on CBT

  • Severe depression and/or anxiety based on the initial evaluation and clinicaljudgment of the study doctor, which warrants a higher level of care and/or immediatereferral to psychiatric services

  • Any other clinical or medical reason in the study doctor's initial screeningevaluation that suggests the study is not appropriate for the participant

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Mobile Cognitive Behavioral App
Phase:
Study Start date:
February 25, 2025
Estimated Completion Date:
March 31, 2028

Study Description

The primary objective of this study is to assess the feasibility and acceptability of "MAYA", a mobile CBT application, in adults who have had a stroke. Feasibility will be measured by the total number of sessions completed and acceptability will be measured by scores on the Mobile Application Rating Scale-User Version (uMARS). Qualitative feedback will also be collected with a questionnaire using open-ended questions.

A secondary objective will be to evaluate preliminary efficacy of the mobile CBT application on symptoms of depression and anxiety assessed using (1) interview-based measures (the Montgomery Asberg Depression Rating Scale [MADRS] and the Hamilton Anxiety Rating Scale [HAM-A]), and (2) a patient reported outcome measure (the 21-item Depression, Anxiety, and Stress Scale [DASS]).

This study will collect pilot data over the course of 8 weeks. Because this is a pilot study, all participants will use the same version of the app and there will be no control group. Primary outcome measures will be collected at baseline (pre-intervention) and at the endpoint (week 8). Participants will be asked to use the mobile app for at least two days a week, for 30 minutes on each day, for 8 weeks. Participants will have weekly check-ins in person or via a HIPAA compliant virtual meeting platform (Zoom) with a study staff member to assess intervention adherence and answer brief questionnaires designed to assess feasibility, acceptability, and mood symptoms.