A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Aug 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people who have had a stroke and are experiencing difficulties with thinking and feelings, such as depression. The treatment involves using an iPad-based program designed to help improve cognitive skills, along with teaching strategies to manage depression. Researchers hope this approach will lead to better daily functioning and improved mental health for those affected by stroke.

To participate in the study, individuals must be at least 18 years old, have had their first stroke at least six months ago, and show signs of both depression and cognitive difficulties. Participants should be able to use an iPad and have stable depression treatment if they are on medication. The study is currently recruiting participants, and those who join can expect to engage in the digital program while receiving support to help manage their symptoms. It’s important to note that individuals with certain severe conditions or those currently in other cognitive rehabilitation programs may not be eligible for this trial.

Gender

ALL

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.