NCT05877885招募中不适用
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AdventHealth
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 =
- •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.
排除标准
- •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.
研究组 & 干预措施
Targeted Cognitive Training Intervention
Experimental
干预措施: Targeted Cognitive Training Intervention (Behavioral)
General Cognitive Training Intervention
Active Comparator
干预措施: General Cognitive Training Intervention (Behavioral)
结局指标
主要结局
Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks
时间窗: Baseline and Post-treatment (Week 4)
Calculated from resting state fMRI scan. Validation of target engagement.
次要结局
- Change in Apathy Evaluation Scale (AES) score(Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4))
- Change in Stroop Interference score(Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4))
研究者
研究点 (1)
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