Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics

Обзор

The goal of this randomized controlled trial is to evaluate the potential of a customized digital cognitive training intervention to target aspects of brain function in apathy of late-life depression and reduce symptoms of apathy and related cognitive and behavioral deficits. The investigators hypothesize that 4 weeks of a customized digital cognitive training program will lead to changes in brain connectivity, apathy severity, and cognitive control performance.

Вмешательства

• Поведенческое Targeted Cognitive Training Intervention
  In this intervention, participants will complete 25-30 minutes of cognitive training per day, 5 days/week (but up to 7 days/week) for 4 weeks. The training protocol will be delivered via the Posit Science Platform, and includes tasks that emphasize training of sustained attention, salience detection, and dimensions of cognitive control. During the 4 week intervention, participants will have weekly 10-20 minute visits with a Care Manager to provide clinical monitoring of symptoms and structured s
• Поведенческое General Cognitive Training Intervention
  In this intervention, participants will complete 25-30 minutes of cognitive activities per day, 5 days/week (but up to 7 days/week) for 4 weeks. The training protocol will be delivered via the Posit Science Platform. The intervention protocol will include computerized cognitive activities designed to provide general cognitive stimulation. During the 4 week intervention, participants will have weekly 10-20 minute visits with a Care Manager to provide clinical monitoring of symptoms and structured

Первичные конечные точки

• Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks [Срок оценки: Baseline and Post-treatment (Week 4)]

Вторичные конечные точки (2)

• Change in Apathy Evaluation Scale (AES) score [Срок оценки: Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)]
• Change in Stroop Interference score [Срок оценки: Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)]

Критерии участия

Критерии включения

• Age 60+ years
• Diagnosis of unipolar major depressive disorder without psychotic features, as assessed by the Mini International Neuropsychiatric Interview
• Montgomery-Åsberg Depression Rating Scale (MADRS) score > or = 16.
• Clinically significant apathy, determined by the Clinician-rated Apathy Evaluation Scale (C-AES > or = to 37)
• Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 5 weeks.
• On a stable dose of other psychotropic medications, deemed by the investigator to be associated with brain networks of interest, for at least 8 weeks.
• Capacity to provide written consent for research assessment and treatment
• Ability to follow written and verbal instructions (English) as assessed by the PI and/or study staff.
• Total score of > 29 on the Telephone Interview for Cognitive Status (TICS)
• Eligible to undergo MRI
• Access to a computer or tablet with Wifi capabilities
• Able to comply with all testing and study requirements and willingness to participate in the full study duration.

Критерии исключения

• History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, persistent depressive disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia
• Use of cholinesterase inhibitors or psychoactive drugs other than antidepressants or benzodiazepines, including antipsychotics, that in the opinion of the Investigator may confound study data/assessments.
• Presence or history of significant neurologic or neurodegenerative disorder (e.g., Alzheimer's disease and other dementias, amnestic Mild Cognitive Impairment, history of stroke, Multiple Sclerosis, Parkinson's disease, epilepsy).
• Any other acute medical condition (e.g., cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses) that may influence brain systems of interest or interfere with participation or interpretation of the study results.
• Participant is currently considered at risk for attempting suicide by the Investigator, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior.
• Electroconvulsive therapy within the past 12 months
• Recent history (within 6 months prior to screening/baseline) of Substance Use Disorder.
• Participant is currently enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is enrolled in psychotherapy, this will not be grounds for exclusion)
• Claustrophobia
• Color Blindness
• Sensory or physical impairment that would preclude cognitive testing or participation in the intervention (e.g., upper limb paralysis) as reported by the participant or observed by the Investigator.
• Travelling consecutively for 2+ weeks during the study period to a location that will preclude timely collection of post-treatment MRI data.
• Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, cochlear implant, any other metallic biomedical implant contraindicating to MRI.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• AdventHealth Neuroscience Institute — Orlando

Идентификаторы

NCT: NCT05877885 · 22-09025304 · K23MH129882

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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