Efficacy and Target Engagement of a Digital Intervention to Improve Depression and Executive Dysfunction After Stroke
Weill Medical College of Cornell University
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-based cognitive training program) with learning cognitive strategies. The hypotheses are that this treatment will improve cognitive skills, depression symptoms, daily function, and brain connectivity. In the short-term, the findings will inform the efficacy of the intervention and in the long-term, may support the use of the intervention to improve co-occurring cognitive and mood difficulties after stroke.
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 evidence of efficacy, side effects, and can be difficult for stroke patients to access. This study aims to evaluate a remote digital intervention for post-stroke DED that combines iPad-based cognitive training using a program called AKL-T01 with virtual coaching to improve executive dysfunction, depression, and daily function after stroke. The primary hypothesis is that individuals randomized to the in…
Eligibility
- Age range
- 50–79 years
- Sex
- All
- Healthy volunteers
- No
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 tre…
Interventions
- DeviceAKL-T01
AKL-T01 is an iPad-based video game designed to improve executive dysfunction and depression symptoms by targeting executive skills (multitasking) and ECN abnormalities.
- BehavioralMetacognitive Strategy Training
Metacognitive Strategy Training involves working with a clinician (neuropsychologist or occupational therapist) to learn strategies to manage cognitive difficulties
Location
- Weill Cornell Medical CenterNew York, New York