Actively Recruiting

Phase 2
Age: 50Years - 79Years
All Genders
NCT05507138

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

Age: 50Years - 79Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Weill Cornell Medical Center

New York, New York, United States, 10065

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here