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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1
Weill Cornell Medical Center
New York, New York, United States, 10065