Recruiting

Cognitive Behavioral Therapy

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06689878

Conditions

Anxiety

Stroke

Depression

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Mobile CBT for Stroke

Study Details

Brief 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.

Conditions

Anxiety

Stroke

Depression

Study ID

NCT06689878

Start date

Feb 25, 2025

Status verified date

Jul, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 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

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.

Interventions

Mobile CBT for Stroke

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 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 ]
  • Number of Sessions completed over study time period [ Time Frame: Week 1 to Week 8 (8 week treatment) ]
  • Qualitative Interview [ Time Frame: Week 8 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

Principal Investigator:

Abhishek Jaywant, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-04.