AnxietyNCT07639606
Mobile Cognitive Behavioral Therapy in Early Stroke Recovery
A study testing Mobile Cognitive Behavioral Therapy App in people with Anxiety and Stroke, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Anxiety, Stroke, Depression - Major Depressive Disorder
- What is being tested?
- Mobile Cognitive Behavioral Therapy App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Abhishek Jaywant, PhD, 212-746-4666, abj2006@med.cornell.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Anxiety, Stroke, Depression - Major Depressive Disorder
- Being tested
- Mobile Cognitive Behavioral Therapy App
- Keywords
- stroke recovery, stroke rehabilitation, cognitive behavioral therapy, CBT
- Medical subject headings
- Anxiety Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Cognitive Behavioral Therapy AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mobile Cognitive Behavioral Therapy App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 5 of treatment
Percent of Sessions completed over study time period
Feasibility will be assessed by the percentage of possible sessions completed
Measured: 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
Measured: From Week 1 to Week 5 of treatment
Secondary outcomes (4)
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.
Measured: Baseline, Week 3
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhishek Jaywant, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639606
- Sponsor's protocol ID
- 26-01029701
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified data including demographic and clinical characteristics of individual participants as well as scores on the primary, secondary, and exploratory outcome measures.
Publications
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.
PubMed 21895880Minshall 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.
PubMed 32191569Lapadatu 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.
PubMed 28075218Mitchell 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.
PubMed 28807138Schottke 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.
PubMed 26178418Medeiros 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.
PubMed 32717644
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Cognitive Behavioral Therapy in Early Stroke Recovery
- ClinicalTrials.gov ID
- NCT07639606
- Acronym / sponsor ID
- 26-01029701
- Conditions
- Anxiety, Stroke, Depression - Major Depressive Disorder
- Keywords
- stroke recovery, stroke rehabilitation, cognitive behavioral therapy, CBT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm Using the Mobile Cognitive Behavioral Therapy App | Experimental | Device: Mobile Cognitive Behavioral Therapy AppThe 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Cognitive Behavioral Therapy AppA 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. | Device | Intervention Arm Using the Mobile Cognitive Behavioral Therapy App |
Primary outcome
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
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
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
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 21895880Caeiro 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.
- Background: PubMed 32191569Minshall 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.
- Background: PubMed 28075218Lapadatu 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.
- Background: PubMed 28807138Mitchell 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.
- Background: PubMed 26178418Schottke 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.
- Background: PubMed 32717644Medeiros 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.
- Individual participant dataSharing planned: Yes. Deidentified data including demographic and clinical characteristics of individual participants as well as scores on the primary, secondary, and exploratory outcome measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abhishek Jaywant, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Cognitive Behavioral Therapy App in people with Anxiety and Stroke, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abhishek Jaywant, PhD (212-746-4666, abj2006@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability of Maya as measured by the Mobile Application Rating Scale-User Version (uMARS) (time frame: Week 5 of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07639606, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.