Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice (POWER)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Depressive Symptoms
研究概览
简要总结
POWER project is a randomized, controlled, non-profit study with the primary objective of testing the effectiveness of non-pharmacological interventions-such as physical activity, cognitive training, and dietary supplementation-in reducing depressive symptoms and preventing or delaying cognitive impairments that frequently co-occur in individuals with Major Depressive Disorder (MDD).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50-80 years old
- •Major Depressive Disorder
- •Absence or mild cognitive impairment
排除标准
- 未提供
研究组 & 干预措施
Placebo
Soy Bean Oil, 3 gram/day
干预措施: Soybean oil (Standard treatment) (Dietary Supplement)
Eicosapentaenoic Acid (EPA)
3 gram/day
干预措施: Eicosapentaenoic acid (omega-3 fatty acid) (Dietary Supplement)
结局指标
主要结局
Depressive Symptoms
时间窗: Weeks 0, 4, 8, 12, 16, 24
The 17-item version (HAMD-17) is used to quantify the severity of depression. A score of ≥18 shows a significant depression level.
Executive Functioning
时间窗: Weeks 0, 4, 12, 24
The Trail Making Test (TMT) evaluates cognitive impairment by measuring the time (in seconds) to complete tasks. Higher scores indicate slower, more impaired performance.
General Cognitive Ability and Memory & Attention
时间窗: Weeks 0, 4, 12, 24
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) uses age-corrected index scores (Mean=100, SD=15) to identify cognitive impairment. Cutoff points for identifying impairment are set at 1 or 1.5 standard deviations (SD) below the mean.
Processing Speed
时间窗: Weeks 0, 4, 12, 24
Commonly used cut-off points for identifying cognitive impairment using the Digit Symbol Substitution Test (DSST) often fall within the range of lower than or equal to 25-35 points.
次要结局
- Gut microbiome composition(Weeks 0 and 24)
- Fatty Acids Profiles in Blood(Weeks 0 and 24)
研究者
Kuan-Pin
Professor
National Science and Technology Council, Taiwan