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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23MH129849-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Individuals with stroke commonly experience both depression and cognitive difficulties. The goal of this study is to evaluate the efficacy of a treatment that combines a digital therapeutic (an iPad-based cognitive training program) with learning cognitive strategies. The hypotheses are that this treatment will improve cognitive skills, depression symptoms, daily function, and brain connectivity. In the short-term, the findings will inform the efficacy of the intervention and in the long-term, may support the use of the intervention to improve co-occurring cognitive and mood difficulties after stroke.
Post-stroke depression with executive dysfunction (DED) is associated with persistent mood and cognitive disturbance, poor social functioning, and disability. Existing interventions have limited evidence of efficacy, side effects, and can be difficult for stroke patients to access. This study aims to evaluate a remote digital intervention for post-stroke DED that combines iPad-based cognitive training using a program called AKL-T01 with virtual coaching to improve executive dysfunction, depression, and daily function after stroke. The primary hypothesis is that individuals randomized to the intervention arm (AKL-T01 + coaching) will demonstrate greater improvement in their executive functioning and depression symptoms and daily function relative to the comparator arm. The secondary hypothesis is that individuals randomized to the intervention arm will demonstrate greater increase in the functional connectivity of the executive control network (ECN, assessed with an MRI scan) at the conclusion of treatment, relative to participants randomized to the comparator arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AKL-T01 | Experimental | Participants in the intervention group will complete 25 minutes of AKL-T01 per day, 5 days/week, for 6 weeks. AKL-T01 trains rapid multitasking on an iPad in an immersive videogame-like environment. Participants complete go/no-go + navigation exercises by moving the iPad to navigate a character on a path while tapping when a certain stimulus is presented and ignoring other stimuli. Participants will also receive weekly 45-minute metacognitive strategy coaching sessions delivered by a clinician. Sessions use guided questions and worksheets (shared virtually) to help participants reflect on their experience with AKL-T01 and link it to daily functioning, generate strategies for daily activities, and explore any emotional responses that arise during gameplay. |
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| Enhanced Metacognitive Strategy Training | Placebo Comparator | In the control group, participants will complete-at the same frequency and duration as the intervention group-iPad-based games designed to provide general cognitive stimulation (word searches, checkers, and "spot the differences" between two pictures). Concurrently with these cognitive stimulation games, participants will receive weekly metacognitive strategy coaching sessions akin to that described above. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKL-T01 | Device | AKL-T01 is an iPad-based video game designed to improve executive dysfunction and depression symptoms by targeting executive skills (multitasking) and ECN abnormalities. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in executive function, as measured by the Oral Symbol Digit Modalities Test (SDMT) | Change in score in the active intervention arm vs. the comparator arm on the SDMT, a performance-based measure of divided attention/working memory with scores ranging from 0-120, with higher scores indicating better performance. | Baseline and end of treatment (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS) | Change in score in the active intervention arm vs. the comparator arm 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Keenan, BS | Contact | 212-746-1509 | alk4028@med.cornell.edu | |
| Abhishek Jaywant, PhD | Contact | 646-289-5204 | 717 | 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 Medical Center | Recruiting | New York | New York | 10065 | United States |
At the conclusion of the study, and after we publish our main results, a deidentified database of individual participant will be available for data sharing. Additionally, we will share study protocol, statistical analysis plan, and analytic code.
We will follow our institution's Data Retention Policy, which dictates that data be made available within three years of closeout of project/grant or upon publication, and that it is available for at least six years, with an additional six years if self-cited.
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 |
|---|---|
| D003863 | Depression |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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Participants will be randomized to the AKL-T01 intervention plus weekly metacognitive strategy coaching (intervention arm) or to weekly metacognitive strategy coaching plus general cognitive stimulation games such as word searches and other puzzles (control arm).
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Participants and clinicians conducting the metacognitive strategy coaching will be instructed not to reveal the group assignment to the member of the research team conducting assessments. Following the completion of recruitment, data will be labelled as "Group A" and "Group B" to avoid bias.
| Metacognitive Strategy Training | Behavioral | Metacognitive Strategy Training involves working with a clinician (neuropsychologist or occupational therapist) to learn strategies to manage cognitive difficulties |
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| Baseline and end of treatment (6 weeks) |
| Change in depression symptoms, as measured by the 9-item Patient Health Questionnaire (PHQ-9) | Change in score in the active intervention arm vs. the comparator arm on the PHQ-9, a self-report questionnaire of depression symptom frequency. Scores range from 0-27, where higher scores are indicative of greater depression symptoms. | Baseline and end of treatment (6 weeks) |
| Change in daily function, as measured by the Neuro Quality of Life (NeuroQOL) Cognitive Function Short Form | Change in score in the active intervention arm vs. the comparator arm on the Neuro Quality of Life (NeuroQOL) Cognitive Function Short Form, a self-report questionnaire of a person's perceived difficulties in cognitive abilities or in their application of such abilities to everyday tasks. Scores range from 8-40 with lower scores representing greater cognitive difficulties. | Baseline and end of treatment (6 weeks) |
| Change in daily function, as measured by the performance-based Weekly Calendar Planning Activity (WCPA) | Change in score in the active intervention arm vs. the comparator arm on the WCPA, a performance based assessment that involves following and organizing a list of appointments or errands into a weekly schedule. Scoring is from 0-17 points, with higher scores indicating better performance. | Baseline and end of treatment (6 weeks) |
| Change in connectivity in the executive control network, as assessed by resting state functional MRI (rs-fMRI). | Change in functional connectivity in the active intervention arm vs. the comparator arm assessed by an rs-fMRI scan. | Baseline and end of treatment (6 weeks) |
| Change in executive function, as measured by the NIH Toolbox Flanker test | Change in total score in the active intervention arm vs. the comparator arm on the NIH Toolbox Flanker test, a timed iPad-based test of executive function where participants have to respond to certain stimuli while ignoring distractors. Score ranges between 0-10, with a higher score indicating better performance. | Baseline and end of treatment (6 weeks) |
| Change in executive function, as measured by the Frontal Systems Behavior Rating Scale (FrSBe) | Change in score in the active intervention arm vs. the comparator arm on the FrSBE, a brief behavioral rating scale for the assessment of behavior disturbances associated with damage to the frontal-subcortical brain circuits. The FrSBe is a 46-item rating scale with three subscales: Apathy, Disinhibition, and Executive Dysfunction. Raw scores range from 46 to 230 overall, which are converted to age adjusted T scores for the Apathy, Disinhibition, and Executive Dysfunction subscales. T scores < 50 reflect less symptoms of apathy, disinhibition, and executive dysfunction. T scores > 50 reflect greater symptoms of apathy, disinhibition, and executive dysfunction. | Baseline and end of treatment (6 weeks) |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |