Mobile Cognitive Behavioral Therapy in Early Stroke Recovery

NCT07639606 | Not Yet Recruiting

• 1 other identifier: 26-01029701
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

stroke recovery; stroke rehabilitation; cognitive behavioral therapy; CBT

Outcome Measures

Primary Outcomes (4)

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

  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 5 of treatment

• Percent of Sessions completed over study time period

  Feasibility will be assessed by the percentage of possible sessions completed

  From Week 1 to Week 5 of treatment

• Percent of homework exercises completed

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

  From Week 1 to Week 5 of treatment

• Qualitative interview

  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 5 of treatment

Secondary Outcomes (2)

• Change in depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS)

  Baseline, Week 3, and Week 5 of treatment

• Change in coping self-efficacy, as measured by the PROMIS Self-Efficacy for Managing Chronic conditions-Managing Emotions 8-item questionnaire (PROMIS-SE)

  Baseline, Week 3, and Week 5 of treatment

Study Arms (1)

Intervention Arm Using the Mobile Cognitive Behavioral Therapy App

EXPERIMENTAL

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.

Behavioral: Mobile Cognitive Behavioral Therapy App

Interventions

Mobile Cognitive Behavioral Therapy App BEHAVIORAL

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.

Intervention Arm Using the Mobile Cognitive Behavioral Therapy App

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (6)

• Caeiro L, Ferro JM, Figueira ML. Apathy in acute stroke patients. Eur J Neurol. 2012 Feb;19(2):291-7. doi: 10.1111/j.1468-1331.2011.03508.x. Epub 2011 Sep 6.

  PMID: 21895880 BACKGROUND

• Minshall C, Castle DJ, Thompson DR, Pascoe M, Cameron J, McCabe M, Apputhurai P, Knowles SR, Jenkins Z, Ski CF. A psychosocial intervention for stroke survivors and carers: 12-month outcomes of a randomized controlled trial. Top Stroke Rehabil. 2020 Dec;27(8):563-576. doi: 10.1080/10749357.2020.1738677. Epub 2020 Mar 19.

  PMID: 32191569 BACKGROUND

• Lapadatu I, Morris R. The relationship between stroke survivors' perceived identity and mood, self-esteem and quality of life. Neuropsychol Rehabil. 2019 Mar;29(2):199-213. doi: 10.1080/09602011.2016.1272468. Epub 2017 Jan 11.

  PMID: 28075218 BACKGROUND

• Mitchell AJ, Sheth B, Gill J, Yadegarfar M, Stubbs B, Yadegarfar M, Meader N. Prevalence and predictors of post-stroke mood disorders: A meta-analysis and meta-regression of depression, anxiety and adjustment disorder. Gen Hosp Psychiatry. 2017 Jul;47:48-60. doi: 10.1016/j.genhosppsych.2017.04.001. Epub 2017 Apr 3.

  PMID: 28807138 BACKGROUND

• Schottke H, Giabbiconi CM. Post-stroke depression and post-stroke anxiety: prevalence and predictors. Int Psychogeriatr. 2015 Nov;27(11):1805-12. doi: 10.1017/S1041610215000988. Epub 2015 Jul 16.

  PMID: 26178418 BACKGROUND

• Medeiros GC, Roy D, Kontos N, Beach SR. Post-stroke depression: A 2020 updated review. Gen Hosp Psychiatry. 2020 Sep-Oct;66:70-80. doi: 10.1016/j.genhosppsych.2020.06.011. Epub 2020 Jun 27.

  PMID: 32717644 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Stroke

Condition Hierarchy (Ancestors)

Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Abhishek Jaywant, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhishek Jaywant, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)