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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AKL-T01
DeviceAKL-T01 is an iPad-based video game designed to improve executive dysfunction and depression symptoms by targeting executive skills (multitasking) and ECN abnormalities.
Metacognitive Strategy Training
BehavioralMetacognitive Strategy Training involves working with a clinician (neuropsychologist or occupational therapist) to learn strategies to manage cognitive difficulties
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: AKL-T01Experimental treatment 2 interventions
Group B: Enhanced Metacognitive Strategy TrainingPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in executive function, as measured by the Oral Symbol Digit Modalities Test (SDMT)
Change in score in the active intervention arm vs. the comparator arm on the SDMT, a performance-based measure of divided attention/working memory with scores ranging from 0-120, with higher scores indicating better performance.
Time frame
Baseline and end of treatment (6 weeks)Secondary outcomes
1
Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)
Change in score in the active intervention arm vs. the comparator arm on the MADRS, a clinician-rated assessment of depression symptom severity that consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depression symptom severity.
Time frame
Baseline and end of treatment (6 weeks)2
Change in depression symptoms, as measured by the 9-item Patient Health Questionnaire (PHQ-9)
Change in score in the active intervention arm vs. the comparator arm on the PHQ-9, a self-report questionnaire of depression symptom frequency. Scores range from 0-27, where higher scores are indicative of greater depression symptoms.
Time frame
Baseline and end of treatment (6 weeks)3
Change in daily function, as measured by the Neuro Quality of Life (NeuroQOL) Cognitive Function Short Form
Change in score in the active intervention arm vs. the comparator arm on the Neuro Quality of Life (NeuroQOL) Cognitive Function Short Form, a self-report questionnaire of a person's perceived difficulties in cognitive abilities or in their application of such abilities to everyday tasks. Scores range from 8-40 with lower scores representing greater cognitive difficulties.
Time frame
Baseline and end of treatment (6 weeks)4
Change in daily function, as measured by the performance-based Weekly Calendar Planning Activity (WCPA)
Change in score in the active intervention arm vs. the comparator arm on the WCPA, a performance based assessment that involves following and organizing a list of appointments or errands into a weekly schedule. Scoring is from 0-17 points, with higher scores indicating better performance.
Time frame
Baseline and end of treatment (6 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov