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Efficacy and target engagement of a digital intervention to improve the depression-executive dysfunction syndrome after stroke

数字干预改善中风后抑郁-执行功能障碍综合征的功效和目标参与度

基本信息

批准号：
10657769
负责人：
Abhishek Jaywant
金额：
$ 19.55万
依托单位：
WEILL MEDICAL COLL OF CORNELL UNIV
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-07-01 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10657769
关键词：
Address Aftercare Anterior Antidepressive Agents Attention Awareness Brain Brain Injuries Chronic Clinical Clinical Trials Clinical Trials Design Cognition Cognitive Collaborations Control Groups Data Data Analytics Depressed mood Digit structure Educational workshop Elderly Executive Dysfunction Functional Magnetic Resonance Imaging Goals Grant Impaired cognition Individual International Intervention Investigational Therapies K-Series Research Career Programs Knowledge Left Manuscripts Measures Mental Depression Mentors Mentorship Modality Modeling Montgomery and Asberg depression rating scale Mood Disorders Neurosciences Participant Patient Self-Report Patients Performance Preparation Psychological Transfer Randomized Research Research Personnel Research Proposals Rest Role Self Perception Short-Term Memory Social Functioning Standardization Stroke Syndrome Testing Time Training Treatment Efficacy Writing affective disturbance brain based career career development cognitive rehabilitation cognitive testing cognitive training comorbidity daily functioning depressive symptoms design digital intervention digital treatment disability efficacious treatment efficacy evaluation executive function experience functional MRI scan functional improvement functional outcomes group intervention improved multitask neuroimaging neuropsychiatry novel performance based measurement personalized intervention post intervention post stroke post stroke cognitive impairment post stroke depression programs remote delivery remote intervention side effect skills stroke patient stroke rehabilitation stroke survivor symposium targeted treatment therapeutic target therapy design treatment optimization virtual

项目摘要

Project Summary/Abstract The goal of the proposed K23 Career Development Award is to provide the PI with the mentorship, knowledge, and skillset to develop into an independent investigator studying neuroscience-inspired, targeted therapeutics for comorbid mood and cognitive dysfunction after stroke. The PI's mentoring team will provide him with training in the brain-based mechanisms of mood disorders, use of functional MRI to examine target engagement, and clinical trial design and data analytic approaches. The training will incorporate individualized tutorials, formal coursework, national and international workshops and conferences, research collaboration, manuscript preparation, and grant writing. The training is integrated in a research proposal that evaluates the efficacy and target engagement of a digital intervention for the depression-executive dysfunction syndrome (DED) after stroke. Stroke is a leading cause of disability worldwide. Post-stroke DED is associated with more persistent depressive symptoms and executive dysfunction, worse social functioning, and greater loss of independence than post-stroke depression or executive dysfunction alone. Existing interventions have limited evidence of efficacy, side effects, and can be difficult for stroke patients to access. Novel and scalable approaches that target the mechanisms underlying post-stroke DED may yield more efficacious treatment. To address these barriers, the PI proposes to study a remote intervention for post-stroke DED that combines an iPad-based digital therapy called AKL-T01 that intensively trains rapid multitasking skills, together with virtual metacognitive coaching. AKL-T01 is designed to target a common mechanism underlying post-stroke depressive symptoms and executive dysfunction, which is reduced intrinsic functional connectivity in the executive control network (ECN). Virtual metacognitive coaching is included to address patient unawareness of deficits to enhance transfer of training gains to daily functioning. In this pilot clinical trial, N=70 patients with a first-time stroke and DED will be randomized to receive the intervention, or to a control condition with general and non-targeted cognitive stimulation together with metacognitive coaching. Participants will complete measures of executive dysfunction, depressive symptoms, and disability at baseline, week 3 (mid treatment), and week 6 (end treatment). Participants will complete resting state fMRI scans at baseline and week 6. Linear mixed-effects models will test the hypotheses that the intervention will be associated with greater improvements in executive function, depressive symptoms, and disability relative to the control group. Also tested is the hypothesis that the intervention group will have greater change in intrinsic functional connectivity in the ECN from baseline to week 6, relative to the control group. This project has the potential to address, in a scalable manner, a highly debilitating consequence of stroke. It will generate data that can be used to optimize treatment efficacy, further refine and personalize the intervention, and further validate a target for treatment.