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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abhishek Jaywant, PhD | Contact | 212-746-4666 | abj2006@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Abhishek Jaywant, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32005328 | Background | 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. | |
| 29704854 | 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. |
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Deidentified data including demographic and clinical characteristics of individual participants as well as scores on the primary, secondary, and exploratory outcome measures.
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.
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.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D020521 | Stroke |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Change in anxiety symptoms, as measured by the Hamilton Anxiety Rating Scale (HAM-A) | 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) | 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) |
| 38163038 | 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. |
| 39163044 | 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. |
| 28807138 | 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. |
| 35352629 | 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. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |