Mobile Cognitive Behavioral Therapy for Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-79
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Mobile CBT for Stroke
DeviceA 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Intervention Arm Using the Mobile Cognitive Behavioral Therapy AppExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 4 of treatment2
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.
Time frame
Week 8 of treatment3
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.
Time frame
Week 1 to Week 8 (8 week treatment)4
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.
Time frame
Week 8 of treatmentSecondary outcomes
1
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.
Time frame
Baseline, Week 4, and Week 8 of treatment (8 week treatment)2
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.
Time frame
Baseline, Week 4, and Week 8 of treatment (8 week treatment)3
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.
Time frame
Baseline, Week 4, and Week 8 of treatment (8 week treatment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov