Digital treatment for depression and cognitive issues after stroke
Efficacy and Target Engagement of a Digital Intervention to Improve Depression and Executive Dysfunction After Stroke
PHASE2 · Weill Medical College of Cornell University · NCT05507138
This study is testing a digital program that uses an iPad and virtual coaching to help people who have had a stroke deal with depression and improve their thinking skills.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 50 Years to 79 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05507138 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced a first-time stroke at least six months prior and are dealing with executive dysfunction and major depressive episodes.
Not a fit: Patients with severe language impairments or those unable to operate an iPad may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive and emotional well-being for stroke survivors.
How similar studies have performed: Other studies have shown promise in using digital interventions for cognitive and mood disorders, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Executive Dysfunction, Depression, Stroke