Status:

RECRUITING

A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

Lead Sponsor:

Weill Medical College of Cornell University

Collaborating Sponsors:

National Institute of Mental Health (NIMH)

Conditions:

Executive Dysfunction

Depression

Eligibility:

All Genders

50-79 years

Phase:

PHASE2

Brief Summary

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-b...

Detailed Description

Post-stroke depression with executive dysfunction (DED) is associated with persistent mood and cognitive disturbance, poor social functioning, and disability. Existing interventions have limited evide...

Eligibility Criteria

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.

Key Trial Info

Start Date :

March 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2026

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT05507138

Start Date

March 1 2023

End Date

July 1 2026

Last Update

May 28 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Weill Cornell Medical Center

New York, New York, United States, 10065

A Digital Intervention for Post-Stroke Depression and Executive Dysfunction | DecenTrialz