A Digital Intervention for Post-Stroke Depression and Executive Dysfunction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-79
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- AKL-T01
- Metacognitive Strategy Training
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov