Digital treatment for depression and cognitive issues after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a digital intervention combining an iPad-based cognitive training program with virtual coaching for individuals experiencing post-stroke depression and executive dysfunction. The aim is to assess the efficacy of this treatment in improving cognitive skills, alleviating depression symptoms, enhancing daily functioning, and increasing brain connectivity. Participants will be randomized into intervention and comparator groups to measure the outcomes of the treatment over time. The study seeks to provide a more accessible and effective option for stroke survivors facing these challenges.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Weill Cornell Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Abhishek Jaywant, PhD — Weill Medical College of Cornell University
• Study coordinator: Alexandra Keenan, BS
• Email: alk4028@med.cornell.edu
• Phone: 212-746-1509

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Deep phenotyping to explore recovery in young adults after stroke

  This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.

  Recruiting The Florey Institute of Neuroscience and Mental Health · Heidelberg, Victoria and 1 other locations · NCT07019493

• Investigation of disabilities following stroke in Taiwan

  This study is looking at how many people have disabilities after a stroke and what might cause them, by following 2,000 stroke patients in Taiwan over a year.

  Recruiting National Taiwan University Hospital · Taipei · NCT06772194

• Stem cell therapy for chronic stroke recovery

  This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.

  Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

• Mobile app for cognitive behavioral therapy in stroke recovery

  This study tests a mobile app called 'MAYA' to see if it can help adults recovering from a stroke manage anxiety and depression through cognitive behavioral therapy.

  Recruiting Weill Medical College of Cornell University · New York, New York · NCT06689878

• Pharmacy-led intervention to improve medication adherence after hospital discharge

  This study tests a pharmacy-led program to help low-income patients with multiple chronic conditions take their medications correctly after leaving the hospital.

  Recruiting University of Tennessee · Knoxville, Tennessee and 1 other locations · NCT06374277

• Exploring brain blood flow and function in stroke, depression, dementia, and delirium

  This study is trying to see how different imaging techniques can help us understand blood flow in the brain of people with stroke, depression, dementia, and delirium, as well as healthy individuals.

  Recruiting University of Leicester · Leicester, Leicestershire and 1 other locations · NCT05649800

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.