Clinical trial NCT05507138: A Digital Intervention for Post-Stroke Depression and Executive Dysfunction
Official title: Efficacy and Target Engagement of a Digital Intervention to Improve Depression and Executive Dysfunction After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Executive Dysfunction
Depression
Stroke
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-08-18
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to the AKL-T01 intervention plus weekly metacognitive strategy coaching (intervention arm) or to weekly metacognitive strategy coaching plus general cognitive stimulation games such as word searches and other puzzles (control arm).
Primary purpose: TREATMENT

Brief 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.

Detailed 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 intervention arm (AKL-T01 + coaching) will demonstrate greater improvement in their executive functioning and depression symptoms and daily function relative to the comparator arm. The secondary hypothesis is that individuals randomized to the intervention arm will demonstrate greater increase in the functional connectivity of the executive control network (ECN, assessed with an MRI scan) at the conclusion of treatment, relative to participants randomized to the comparator arm.

Eligibility criteria: 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 participate in the full study duration

Exclusion Criteria:

* 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 services.
* pregnancy
* any other clinical or medical reason in the PI's initial screening evaluation that suggests the study is not appropriate for the participant.

Primary outcomes:
measure: Change in executive function, as measured by the Oral Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline and end of treatment (6 weeks)
Secondary outcomes:
measure: Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline and end of treatment (6 weeks)
measure: Change in depression symptoms, as measured by the 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline and end of treatment (6 weeks)
measure: Change in daily function, as measured by the Neuro Quality of Life (NeuroQOL) Cognitive Function Short Form
timeFrame: Baseline and end of treatment (6 weeks)
measure: Change in daily function, as measured by the performance-based Weekly Calendar Planning Activity (WCPA)
timeFrame: Baseline and end of treatment (6 weeks)
measure: Change in connectivity in the executive control network, as assessed by resting state functional MRI (rs-fMRI).
timeFrame: Baseline and end of treatment (6 weeks)
measure: Change in executive function, as measured by the NIH Toolbox Flanker test
timeFrame: Baseline and end of treatment (6 weeks)
measure: Change in executive function, as measured by the Frontal Systems Behavior Rating Scale (FrSBe)
timeFrame: Baseline and end of treatment (6 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Abhishek Jaywant, PhD
role: PRINCIPAL_INVESTIGATOR
References: