Mobile Cognitive Behavioral Therapy in Early Stroke Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Mobile Cognitive Behavioral Therapy App
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 5 of treatment2
Percent of Sessions completed over study time period
Feasibility will be assessed by the percentage of possible sessions completed
Time frame
From Week 1 to Week 5 of treatment3
Percent of homework exercises completed
Feasibility will be assessed by the percentage of assigned homework exercises that are completed
Time frame
From Week 1 to Week 5 of treatmentSecondary outcomes
1
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.
Time frame
Baseline, Week 32
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.
Time frame
Baseline, Week 53
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.
Time frame
Baseline, Week 34
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.
Time frame
Baseline, Week 5Sponsors and contacts
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Source ClinicalTrials.gov