A Digital Intervention for Post-Stroke Depression and Executive Dysfunction
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
| Condition(s) | Executive Dysfunction, Depression, Stroke |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 part |
| Ages | 50 Years to 79 Years |
| Sex | All |
| Lead sponsor | Weill Medical College of Cornell University |
| Locations | New York, New York, United States |
| Start date | 2023-03-01 |
| NCT ID | NCT05507138 |
| Official listing | https://clinicaltrials.gov/study/NCT05507138 |