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NCT Number: NCT07639606

Mobile Cognitive Behavioral Therapy in Early Stroke Recovery

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.

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Key information

Conditions

Anxiety Anxiety Disorders Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression - Major Depressive Disorder Mental Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The focus of the present study is neuropsychiatric symptoms (i.e., depression, apathy, and anxiety) in individuals who experienced a stroke. Post-stroke neuropsychiatric symptoms are highly prevalent and are associated with diminished quality of life, caregiver distress, and poorer functional capacity and stroke recovery.

The intervention used in the present study is an adapted version of Maya, a cognitive behavioral therapy (CBT) application. The app includes modules with educational content and practice of strategies that address the following: (1) education about mood symptoms post-stroke and their association with recovery/rehabilitation; (2) mindfulness, relaxation, and distress tolerance skills; (3) increasing awareness of thinking errors and reframing negative thoughts; and (4) self-compassion, gratitude, and ways to promote resilience during stroke recovery and rehabilitation. The app includes an interactive dashboard to provide the user with statistics for tracking progress toward their goals. For the current study, app language and examples will be adapted for individuals with stroke. Participants will be asked to use the app for 3 days per week over a 5-week period, for ~20 minutes in each use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Cognitive Behavioral Therapy App

Device

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 outcomes

  1. Feasibility and Acceptability of Maya as measured by the Mobile Application Rating Scale-User Version (uMARS)

    Time frame: Week 5 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

  2. Percent of Sessions completed over study time period

    Time frame: From Week 1 to Week 5 of treatment

    Feasibility will be assessed by the percentage of possible sessions completed

  3. Percent of homework exercises completed

    Time frame: From Week 1 to Week 5 of treatment

    Feasibility will be assessed by the percentage of assigned homework exercises that are completed

Secondary outcomes

  1. Mean change from baseline to week 3 in depression and anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline, Week 3

    Change in score on the HADS, a self-report measure of depression and anxiety symptom severity consisting of 14 items. Each item is rated on a 0-3 scale, with higher scores indicative of greater symptom severity. The maximum possible score is 42.

  2. Mean change from baseline to week 5 in depression and anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline, Week 5

    Change in score on the HADS, a self-report measure of depression and anxiety symptom severity consisting of 14 items. Each item is rated on a 0-3 scale, with higher scores indicative of greater symptom severity. The maximum possible score is 42.

  3. Mean change from baseline to week 3 in coping self-efficacy as measured by the PROMIS Self-Efficacy for Managing Chronic conditions-Managing Emotions 8-item questionnaire (PROMIS-SE)

    Time frame: Baseline, Week 3

    Change in score on the PROMIS-SE, a patient-reported measure of self-efficacy with managing emotions related to health conditions. There are 8 items, each rated on a 1-5 scale, with higher scores indicating greater coping self-efficacy. The maximum total score is 40.

  4. Mean change from baseline to week 5 in coping self-efficacy as measured by the PROMIS Self-Efficacy for Managing Chronic conditions-Managing Emotions 8-item questionnaire (PROMIS-SE)

    Time frame: Baseline, Week 5

    Change in score on the PROMIS-SE, a patient-reported measure of self-efficacy with managing emotions related to health conditions. There are 8 items, each rated on a 1-5 scale, with higher scores indicating greater coping self-efficacy. The maximum total score is 40.

Study contacts

Contact information is provided by the study sponsor or research team.

Abhishek Jaywant, PhD

CONTACT

[email protected]

212-746-4666

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 10, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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