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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline to week 3 in depression and anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) | 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. | Baseline, Week 3 |
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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 | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21895880 | Background | 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. | |
| 32191569 | 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. |
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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 |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Mean change from baseline to week 5 in depression and anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) | 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. | Baseline, Week 5 |
| 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) | 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. | Baseline, Week 3 |
| 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) | 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. | Baseline, Week 5 |
| 28075218 | 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. |
| 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. |
| 26178418 | 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. |
| 32717644 | 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. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |