NCT07186023招募中不适用
Intervention Evaluation for Late-life Depression in Taiwan Urban and Rural Areas: Long-term Tracking and Prediction of Non-pharmaceutical Interventions by Smart AI Technologies
National Health Research Institutes, Taiwan4 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2025年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- Changes in neural activation related to emotional processing, sensory processing, attention, and memory-related brain regions.
研究概览
简要总结
This randomized controlled trial will examine the effects of mindfulness-based interventions and brain stimulation interventions on cognitive function and psychological well-being in older adults. The study will employ a comprehensive assessment approach incorporating psychological evaluations, behavioral assessments, psychophysiological measurements, and neuroimaging analyses to characterize the outcome of nonpharmaceutical interventions in improving geriatric well-being or reducing depression severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for individuals participating in mindfulness-based Interventions:
- •Literate or have received an education above the elementary level.
- •Have normal or corrected vision and hearing, able to communicate and understand explanations.
- •Right-handed individuals as assessed by the Edinburgh Handedness Inventory.
排除标准
- •for individuals participating in mindfulness-based Interventions:
- •Individuals with dementia, stroke, cerebrovascular disease, brain injury, epilepsy, or Parkinson's disease.
- •Individuals with neurological system disorders.
- •Individuals with alcohol or drug dependence.
- •Individuals with other major physical illnesses, such as diabetes, heart failure, or endocrine abnormalities, or those who have experienced an acute myocardial infarction within the past three months.
- •Individuals with metal objects in the body that cannot undergo magnetic resonance imaging (MRI), such as cardiac pacemakers, vascular clips, hearing aids, artificial joints, steel pins, etc.
- •Individuals with Claustrophobia.
- •Individuals in pregnancy or possibility of pregnancy.
- •Inclusion Criteria for individuals participating in brain stimulation Intervention:
- •Individuals diagnosed with major depressive disorder by psychiatrists according to the Diagnostic and Statistical Manual, and who can cooperate with the psychiatric outpatient clinic regulations.
- •Literate or have received an education above the elementary level.
- •Have normal or corrected vision and hearing, able to communicate and understand explanations.
- •Right-handed individuals as assessed by the Edinburgh Handedness Inventory.
- •Individuals are prescribed brain stimulation therapy by clinical physicians.
- •Exclusion Criteria for individuals participating in brain stimulation Intervention:
- •Individuals with dementia, stroke, cerebrovascular disease, brain injury, epilepsy, or Parkinson's disease.
- •Individuals with neurological system disorders.
- •Individuals with alcohol or drug dependence.
- •Individuals with other major physical illnesses, such as diabetes, heart failure, or endocrine abnormalities, or those who have experienced an acute myocardial infarction within the past three months.
- •Individuals with metal objects in the body that cannot undergo magnetic resonance imaging (MRI), such as cardiac pacemakers, vascular clips, hearing aids, artificial joints, steel pins, etc.
- •Individuals with Claustrophobia.
- •Individuals in pregnancy or possibility of pregnancy.
结局指标
主要结局
Changes in neural activation related to emotional processing, sensory processing, attention, and memory-related brain regions.
时间窗: Baseline assessment conducted during the 4-week period prior to intervention initiation; follow-up assessment conducted during the 4-week period following intervention completion.
Significant alterations in blood oxygen level-dependent (BOLD) signal amplitude during task-based functional magnetic resonance imaging (fMRI).
Changes in resting-state functional connectivity within and between brain networks
时间窗: Baseline assessment conducted during the 4-week period prior to intervention initiation; follow-up assessment conducted during the 4-week period following intervention completion.
Statistically significant alterations in intrinsic functional connectivity parameters derived from blood-oxygen-level-dependent (BOLD) signals acquired during resting-state functional magnetic resonance imaging (rs-fMRI).
次要结局
- Regional brain morphometric changes, assessed by quantitative analysis of gray matter volume, thickness, and density differences using high-resolution structural magnetic resonance imaging.(Baseline assessment conducted during the 4-week period prior to intervention initiation; follow-up assessment conducted during the 4-week period following intervention completion.)
- Self-reported neuropsychological outcomes assessed through validated Wechsler Adult Intelligence Scale (WAIS).(Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).)
- Scores of the total number of category-naming items correctly named within one minute for testing verbal fluency.(Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).)
- Changes in the depression scale(Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).)
- Changes in anxiety scale(Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).)
- Changes in the loneliness scale(Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).)
- Changes in perceived stress(Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).)
- Changes in the apathy scale(Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).)
- Changes in self-reported sleep outcomes assessed through sleepiness and sleep quality(Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).)
- Changes in self-reported intervention outcomes in terms of mindfulness, flourishing, and well-being(Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).)
- Dynamic patterns of objective sleep parameters assessed through smart watch monitoring(Continuous physiological monitoring conducted from 4 weeks pre-intervention through 4 weeks post-completion of the 1-month follow-up period (total monitoring duration: 16 weeks).)
- Dynamic patterns of objective cardiovascular parameters assessed through smart watch monitoring(Continuous physiological monitoring conducted from 4 weeks pre-intervention through 4 weeks post-completion of the 1-month follow-up period (total monitoring duration: 16 weeks).)
研究者
Ai-Ling Hsu
Assistant Investigator
National Health Research Institutes, Taiwan
研究点 (4)
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