Back to search results

Digital Intervention for Post-Stroke Depression and Executive Dysfunction

This study is testing a new approach for people who have had a stroke and are experiencing both depression and difficulties with executive function (like planning and multitasking). The treatment combines an iPad-based video game called AKL-T01 with Metacognitive Strategy Training, where you work with a therapist to learn ways to manage cognitive challenges. Researchers want to see if this combined treatment can improve your cognitive skills, reduce depression symptoms, and help with daily activities. To join, you must be between 50 and 79 years old, have had your first stroke at least 6 months ago, and have both executive dysfunction and a diagnosis of Major Depressive Episode. The study aims to measure changes in executive function after 6 weeks of treatment. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 70 participants. It compares the combined treatment of AKL-T01 and coaching against a comparator arm.
What's involved
You would participate in a treatment that lasts for 6 weeks. Your executive function will be measured at the beginning and end of this treatment period.
Compensation
Not stated in the trial record.
Follow-up
Your executive function will be measured at the end of treatment (6 weeks).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05507138

A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

Recruiting
PHASE2Ages 50–79InterventionalTreatment
Weill Medical College of Cornell University
~70 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:AKL-T01Metacognitive Strategy Training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in executive function, as measured by the Oral Symbol Digit Modalities Test (SDMT)
Measured over Baseline and end of treatment (6 weeks)

Conditions

Executive Dysfunction
Depression
Stroke

Explore related trials

DepressionExecutive Function DisorderStroke

NCT05507138

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Weill Cornell Medical Center

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Abhishek Jaywant, PhD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Alexandra Keenan, BS
[email protected]
212-746-1509
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Change in executive function, as measured by the Oral Symbol Digit Modalities Test (SDMT)Baseline and end of treatment (6 weeks)

    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.