Mobile Cognitive Behavioral Therapy for Stroke

NCT06689878 | Recruiting

• 1 other identifier: 24-04027396
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

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 4 of treatment

• 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 8 of treatment

• Number of Sessions completed over study time period

  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

  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 Outcomes (3)

• Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)

  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)

  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)

  Baseline, Week 4, and Week 8 of treatment (8 week treatment)

Study Arms (1)

Intervention Arm Using the Mobile Cognitive Behavioral Therapy App

EXPERIMENTAL

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

Interventions

Mobile Cognitive Behavioral 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.

Also known as: Maya

Intervention Arm Using the Mobile Cognitive Behavioral Therapy App

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Related Publications (6)

• Wilhelm S, Weingarden H, Ladis I, Braddick V, Shin J, Jacobson NC. Cognitive-Behavioral Therapy in the Digital Age: Presidential Address. Behav Ther. 2020 Jan;51(1):1-14. doi: 10.1016/j.beth.2019.08.001. Epub 2019 Aug 8.

  PMID: 32005328 BACKGROUND

• Wang SB, Wang YY, Zhang QE, Wu SL, Ng CH, Ungvari GS, Chen L, Wang CX, Jia FJ, Xiang YT. Cognitive behavioral therapy for post-stroke depression: A meta-analysis. J Affect Disord. 2018 Aug 1;235:589-596. doi: 10.1016/j.jad.2018.04.011. Epub 2018 Apr 5.

  PMID: 29704854 BACKGROUND

• Wada Y, Otaka Y, Yoshida T, Takekoshi K, Takenaka R, Senju Y, Maeda H, Shibata S, Kishi T, Hirano S. Effect of Post-stroke Depression on Functional Outcomes of Patients With Stroke in the Rehabilitation Ward: A Retrospective Cohort Study. Arch Rehabil Res Clin Transl. 2023 Aug 2;5(4):100287. doi: 10.1016/j.arrct.2023.100287. eCollection 2023 Dec.

  PMID: 38163038 BACKGROUND

• Bress JN, Falk A, Schier MM, Jaywant A, Moroney E, Dargis M, Bennett SM, Scult MA, Volpp KG, Asch DA, Balachandran M, Perlis RH, Lee FS, Gunning FM. Efficacy of a Mobile App-Based Intervention for Young Adults With Anxiety Disorders: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2428372. doi: 10.1001/jamanetworkopen.2024.28372.

  PMID: 39163044 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

• Ahrens J, Shao R, Blackport D, Macaluso S, Viana R, Teasell R, Mehta S. Cognitive -behavioral therapy for managing depressive and anxiety symptoms after stroke: a systematic review and meta-analysis. Top Stroke Rehabil. 2023 May;30(4):368-383. doi: 10.1080/10749357.2022.2049505. Epub 2022 Mar 30.

  PMID: 35352629 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Stroke; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

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: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: February 25, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

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)