A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

NCT ID: NCT05507138

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-07-01

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.

Conditions

Executive Dysfunction; Depression; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AKL-T01

Participants in the intervention group will complete 25 minutes of AKL-T01 per day, 5 days/week, for 6 weeks. AKL-T01 trains rapid multitasking on an iPad in an immersive videogame-like environment. Participants complete go/no-go + navigation exercises by moving the iPad to navigate a character on a path while tapping when a certain stimulus is presented and ignoring other stimuli. Participants will also receive weekly 45-minute metacognitive strategy coaching sessions delivered by a clinician. Sessions use guided questions and worksheets (shared virtually) to help participants reflect on their experience with AKL-T01 and link it to daily functioning, generate strategies for daily activities, and explore any emotional responses that arise during gameplay.

Group Type: EXPERIMENTAL

AKL-T01

Intervention Type: DEVICE

AKL-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

Intervention Type: BEHAVIORAL

Metacognitive Strategy Training involves working with a clinician (neuropsychologist or occupational therapist) to learn strategies to manage cognitive difficulties

Enhanced Metacognitive Strategy Training

In the control group, participants will complete-at the same frequency and duration as the intervention group-iPad-based games designed to provide general cognitive stimulation (word searches, checkers, and "spot the differences" between two pictures). Concurrently with these cognitive stimulation games, participants will receive weekly metacognitive strategy coaching sessions akin to that described above.

Group Type: PLACEBO_COMPARATOR

Metacognitive Strategy Training

Intervention Type: BEHAVIORAL

Metacognitive Strategy Training involves working with a clinician (neuropsychologist or occupational therapist) to learn strategies to manage cognitive difficulties

Interventions

AKL-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.

Intervention Type: DEVICE

Metacognitive Strategy Training

Metacognitive Strategy Training involves working with a clinician (neuropsychologist or occupational therapist) to learn strategies to manage cognitive difficulties

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abhishek Jaywant, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexandra Keenan, BS

Role: CONTACT

alk4028@med.cornell.edu

212-746-1509

Abhishek Jaywant, PhD

Role: CONTACT

abj2006@med.cornell.edu

646-289-5204 ext. 717

Facility Contacts

Abhishek Jaywant, PhD

Role: primary

abj2006@med.cornell.edu

646-289-5204 ext. 717

Other Identifiers

1K23MH129849-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-11024159

Identifier Type: -

Identifier Source: org_study_id