Mobile Cognitive Behavioral Therapy for Stroke

March 25, 2026 updated by: Weill Medical College of Cornell University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
        • Principal Investigator:
          • Abhishek Jaywant, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 40-79
  • Presence of clinically-significant anxiety and/or depression (as determined by an eligibility 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 evaluation conducted as part of the study
  • If taking medication for depression and/or anxiety, must be on a stable dose for a minimum 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 Criteria:

  • Aphasia of moderate or greater severity (as determined during an eligibility evaluation)
  • 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 the individual's psychotherapy is primarily focused on CBT
  • Severe depression and/or anxiety based on the initial evaluation and clinical judgment of the study doctor, which warrants a higher level of care and/or immediate referral to psychiatric services
  • Any other clinical or medical reason in the study doctor's initial screening evaluation that suggests the study is not appropriate for the participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm Using the Mobile Cognitive Behavioral Therapy App
All participants will receive the same intervention arm, a mobile cognitive behavioral therapy (CBT) app that includes modules with educational content and teaching and practice of strategies that address the following: education about anxiety and depression and their association with stroke recovery; awareness and monitoring of emotions; behavioral activation, i.e., increasing engagement in valued and meaningful activities; increasing awareness of thinking errors and reframing negative thoughts; mindfulness; relaxation skills; increasing tolerance of anxiety in anxiety-provoking situations; and problem-solving. The application includes an interactive dashboard to provide the user with statistics for tracking progress toward their goals. Participants will be asked to use the application for 30 minutes per day, 2 days per week, for 8 weeks.
Behavioral: Mobile Cognitive Behavioral 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.
Other Names:
  • Maya

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and Acceptability of MAYA as measured by the Mobile Application Rating Scale-User Version (uMARS)
Time Frame: Week 4 of treatment
Feasibility and acceptability will be measured by the scores collected on the uMARS by assessing the sub scores of Engagement, Functionality, Aesthetics, and Information of the app to measure the perceived quality of the app. The outcome is the mean of the individual items, ranging from 1 to 5, with 1 denoting minimal satisfaction/rating of app quality and 5 denoting maximum satisfaction and highest rating of app quality.
Week 4 of treatment
Feasibility and Acceptability of MAYA as measured by the Mobile Application Rating Scale-User Version (uMARS)
Time Frame: Week 8 of treatment
Feasibility and acceptability will be measured by the scores collected on the uMARS by assessing the sub scores of Engagement, Functionality, Aesthetics, and Information of the app to measure the perceived quality of the app. The outcome is the mean of the individual items, ranging from 1 to 5, with 1 denoting minimal satisfaction/rating of app quality and 5 denoting maximum satisfaction and highest rating of app quality.
Week 8 of treatment
Number of Sessions completed over study time period
Time Frame: Week 1 to Week 8 (8 week treatment)
To assess the feasibility of "MAYA" in adults who have had a stroke, by assessing the number of sessions completed.
Week 1 to Week 8 (8 week treatment)
Qualitative Interview
Time Frame: Week 8 of treatment
This is a series of questions with open-ended responses that are designed to ask participants about their experience using the app and completing the CBT program. There is no numerical scoring; responses are evaluated qualitatively to explore engagement with the app.
Week 8 of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline, Week 4, and Week 8 of treatment (8 week treatment)
Change in score on the MADRS, a clinician-rated assessment of depression symptom severity that consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depression symptom severity.
Baseline, Week 4, and Week 8 of treatment (8 week treatment)
Change in anxiety symptoms, as measured by the Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: Baseline, Week 4, and Week 8 of treatment (8 week treatment)
Change in score on the HAM-A, a clinician-rated assessment of anxiety symptom severity that consists of 14 items; each item is rated on a 0-4 scale, resulting in a maximum total score of 56 points, with higher scores indicative of greater anxiety symptom severity.
Baseline, Week 4, and Week 8 of treatment (8 week treatment)
Change in depression, anxiety, and stress, as measured by the Depression, Anxiety, and Stress Scale (DASS)
Time Frame: Baseline, Week 4, and Week 8 of treatment (8 week treatment)
Change in score on the DASS, a patient-reported symptom measure of depression, anxiety, and stress symptom severity that consists of 21 items; each item is rated on a 0-3 scale, resulting in a maximum total score of 63 points, with higher scores indicative of greater depression, anxiety, and/or stress symptom severity.
Baseline, Week 4, and Week 8 of treatment (8 week treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Abhishek Jaywant, PhD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-04027396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data including demographic and clinical characteristics of individual participants as well as scores on the primary, secondary, and exploratory outcome measures.

IPD Sharing Time Frame

At the conclusion of the study, and after the researchers publish their main results, a deidentified database of individual participants will be available for data sharing. This database will be available for at least six years following the publication of the main results.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. All researchers requesting data will commit to using the data solely for research purposes; will have data shared that are pertinent to their research question/hypotheses; secure the data; return or destroy it once analyses are completed; do not share it with other researchers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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