Anxiety, Depression - Major Depressive Disorder, Stroke
Conditions
Keywords
stroke recovery, stroke rehabilitation, cognitive behavioral therapy, CBT
Brief 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.
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.
Interventions
DEVICEMobile Cognitive Behavioral Therapy App
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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Acceptability of Maya as measured by the Mobile Application Rating Scale-User Version (uMARS) | 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 | From Week 1 to Week 5 of treatment | Feasibility will be assessed by the percentage of possible sessions completed |
| Percent of homework exercises completed | From Week 1 to Week 5 of treatment | Feasibility will be assessed by the percentage of assigned homework exercises that are completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline to week 3 in depression and anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) | Baseline, Week 3 | 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. |
| Mean change from baseline to week 5 in depression and anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) | Baseline, Week 5 | 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. |
| 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) | Baseline, Week 3 | 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. |
| 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) | Baseline, Week 5 | 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. |
Countries
United States
Contacts
CONTACTAbhishek Jaywant, PhD
PRINCIPAL_INVESTIGATORAbhishek Jaywant, PhD
Weill Medical College of Cornell University
Outcome results
None listed