A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

Recruiting now · Phase 2

Conditions studied: Executive Dysfunction, Depression, Stroke

In brief

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.

Key facts

Study ID

NCT05507138

Run by

Weill Medical College of Cornell University

People needed

70

Starts

2023-03-01

Expected to finish

2026-09-30

Last updated by the study team

2026-04-22

Who can join

Age: 50 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• first-time stroke that occurred 6 months or more prior to study initiation
• executive dysfunction as defined by a score of less than 1 standard deviation below age-adjusted normative score on at least one test of executive function in the screening assessment
• diagnosis of Major Depressive Episode assessed by the Structured Clinical Interview for the DSM-5 (SCID).
• at least moderate depressive symptoms as defined by Montgomery Asberg Depression Rating Scale ≥ 18
• motor function sufficient to operate an iPad and use a pen, based on self-report and observation
• if treated with an antidepressant medication, must be on a stable dose for a minimum of 8 weeks at the time of study enrollment.
• able to adhere to all testing and study requirements and willingness to participate in the full study duration

You may not qualify if…

• receptive aphasia as determined by a score of 2 or 3 on the NIH Stroke Scale [NIHSS] item 9 ("Best Language")
• dysarthria that makes speech unintelligible (score of 2 on NIHSS item #10)
• severe visual impairment or hemispatial neglect (score of 3 on NIHSS item #3 or score of 2 on NIHSS item #11)
• patient already enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is already enrolled in psychotherapy, this will not be grounds for exclusion)
• non-fluency in English
• presence of or history of significant neurologic or neurodegenerative disorder other than stroke
• presence of dementia based on dependence in basic ADLs due to cognitive deficits
• history of psychosis or mania (evaluated using the SCID).
• active suicide ideation (assessed via the Columbia Suicide Severity Rating Scale)
• severe executive dysfunction (based on clinical judgment during screening evaluation) precluding use of the iPad
• severe depression-even in the absence of active suicidal ideation-based on the screening evaluation and clinical judgment of the PI, which warrants a higher level of care and/or immediate referral to psychiatric services.
• pregnancy
• any other clinical or medical reason in the PI's initial screening evaluation that suggests the study is not appropriate for the participant.

Where it is running

• Weill Cornell Medical Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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