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New treatment option for Executive Dysfunction
Official title A Digital Intervention for Post-Stroke Depression and Executive Dysfunction
ClinicalTrials.gov ID: NCT05507138
What this study is testing
- What it's testing
- 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-based cognitive training program) with learning cognitive strategies.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 79
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- non-fluency in English
- presence of or history of significant neurologic or neurodegenerative disorder other than stroke
See the full eligibility 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
- 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...
- pregnancy
- any other clinical or medical reason in the PI's initial screening evaluation that suggests the study is not appropriate for the participant.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.