Effect of a Six-week Integrated Attention Training Program on the Cognitive Functions of Older Adults With Co-occurring Anxiety Symptoms and Subjective Cognitive Complaints
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Anxiety symptoms
研究概览
简要总结
The goal of this single-blind randomized control trial is to compare a 6-week Integrated Attention Training Program (IATP) and health education in older people with co-occurrence of anxiety symptoms and subjective cognitive decline (SCC).
The study aims to answer if a 6-week Integrated Attention Training Program (IATP) will improve cognitive, anxiety, and level of pro-inflammatory biomarkers in this high-risk group.
Older adults with co-occurring anxiety and SCC will be recruited to participate in a 6-week single-blind randomized controlled trial. IATP group (Intervention group) will undergo attention and functional training. Control group will receive health education.
Investigators will compare the IATP with health education to see if cognitive function, anxiety symptoms, and level of pro-inflammatory biomarkers in comparison to health education will improved after intervention and over 24 weeks.
详细描述
This is a 2-armed randomized control trial. For both groups, participants will attend a 45-minute training twice a week for consecutive 6 weeks in a group of 6 people. IATP group (I) will begin with 5 minutes of warm up to give instructions, followed by 5 minutes of breathing exercises, 5 minutes of body scanning, 10 minutes of dual-task training, 15 minutes of functional training, and 5 minutes of performance appraisal under guidance of an intervention instructor. Control group (C) will receive 12 sessions of health education on managing chronic diseases or conditions commonly found in old age during the intervention period.
Assessments will take place at baseline (T0), immediately after intervention (T1) and after 24-week (T2).
Measurement will include a battery of cognitive assessments, Hamilton Anxiety Scale (HAM-A), and a questionnaire on sociodemographic characteristics (age, sex, educational level, and socioeconomic status), physical and mental health statuses, and lifestyle patterns (smoking, drinking, and leisure activities in the past one month). In addition, a 15ml blood sample will be collected from each consenting participant by a phlebotomist for an inflammatory assay analysis at T0. Follow-up assessments and blood collections will be arranged at 6th (T1) and 24th (T2) week.
Linear mixed effects models will analyze the changes on anxiety and cognitive performance from baseline to endpoints. All the analyses will be based on Intention-to-treat principle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older adults aged 60 to 90 years;
- •No Major Neurocognitive Disorders
- •Presence of anxiety symptoms
- •Presence of Subjective Cognitive Complaints
排除标准
- •Clinical dementia
- •History of major depression
- •Presence of major neurological deficit
- •Presence of severe visual impairment; or
- •Currently on any psychotropic or other medications known to affect cognition; or
- •Participation in other cognitive trainings or interventions 6 months prior to this study or during the study period.
研究组 & 干预措施
IATP
干预措施: Integrated Attention Training Program (Behavioral)
Control
结局指标
主要结局
Anxiety symptoms
时间窗: 6 weeks after baseline and 6 months after baseline
Hamilton Anxiety Scale (HAM-A) - each item will be scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where 17 or less indicates a mild severity, 18-24 indicates a mild to moderate severity and 25-30 a moderate to severe severity.
Attention - Digit Span Forward Task
时间窗: 6 weeks after baseline and 6 months after baseline
Participants are asked to repeat a series of digits immediately after presentation, in ascending order starting from 3 and up to 8 digits. Analysis of scoring is based on the span length achieved.
Executive function - Digit Span Backwards Task
时间窗: 6 weeks after baseline and 6 months after baseline
Participants will be asked to repeat a series of digits immediately after presentation, in reverse order starting from 2 and up to 8 digits. Analysis of scoring is based on the span length achieved.
Attention - Chinese Trail Making Test - Part A (CTMT-A)
时间窗: 6 weeks after baseline and 6 months after baseline
The participant will need to connect between Arabic and Chinese numbers in sequential order. The completion time (in second) and the numbers of errors made during the test are recorded
Executive function - Category Verbal Fluency Test (CVFT)
时间窗: 6 weeks after baseline and 6 months after baseline
It is test of semantic fluency and executive function. Participants were asked to generate as many exemplars as possible for each of the three semantic categories, namely animals, fruits, and vegetables, in 60 seconds. Their responses were recorded in serial order. Analysis of scoring is based on the total number of words that the participant is able to produce across all three categories.
Executive function - Chinese Trail Making Test - Part B (CTMT-B)
时间窗: 6 weeks after baseline and 6 months after baseline
The participant will need to connect and alternate between Arabic and Chinese numbers. The completion time (in second) and the numbers of errors made during the test are recorded.
Level of inflammation
时间窗: 6 weeks after baseline and 6 months after baseline
Levels of IL-1β
次要结局
- Functional performance - Chinese version of Disability of Assessment in dementia (CDAD)(6 weeks after baseline and 6 months after baseline)