Actively Recruiting
A Digital Intervention for Post-Stroke Depression and Executive Dysfunction
Led by Weill Medical College of Cornell University · Updated on 2026-04-22
70
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Digital Intervention for Post-Stroke Depression and Executive Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First-time stroke that occurred 6 months or more before the study starts
- Executive dysfunction with a score below 1 standard deviation on at least one executive function test
- Diagnosis of Major Depressive Episode confirmed by Structured Clinical Interview for DSM-5
- Moderate or greater depression symptoms with a Montgomery Asberg Depression Rating Scale score of 18 or higher
- Sufficient motor skills to operate an iPad and use a pen
- Stable antidepressant medication dose for at least 8 weeks if applicable
- Ability and willingness to follow all testing and study requirements for the full study duration
You will not qualify if you...
- Receptive aphasia with a score of 2 or 3 on NIH Stroke Scale item 9
- Speech unintelligible due to dysarthria (score of 2 on NIH Stroke Scale item 10)
- Severe visual impairment or hemispatial neglect (scores of 3 on item 3 or 2 on item 11 of NIH Stroke Scale)
- Currently enrolled in ongoing cognitive rehabilitation
- Not fluent in English
- History or presence of significant neurological or neurodegenerative disorders other than stroke
- Dementia causing dependence in basic daily activities
- History of psychosis or mania
- Active suicidal thoughts
- Severe executive dysfunction preventing use of iPad
- Severe depression requiring higher level care or immediate psychiatric referral
- Pregnancy
- Any other medical or clinical reason deemed unsuitable by the principal investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
A
Alexandra Keenan, BS
CONTACT
A
Abhishek Jaywant, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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