A Pilot Study on Randomized Control Trial Comparing Integrated Attention Training Program (IATP) and Health Education on Preservation of Cognitive Functioning in Chinese Older Adults With Anxiety Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Attention network test (ANT)
研究概览
简要总结
Older adults with anxiety symptoms was found to be associated with greater risk of dementia. Interventions targeting signs as early as in the pre-symptomatic phase could be most effective in early prevention of dementia. On reviewing the identified non-pharmacological interventions, integrated attention training program (IATP) is proposed to target older adults with anxiety symptoms in Hong Kong.
详细描述
Older adults with anxiety disorders or symptoms are not in the consideration of management for dementia prevention. However, the condition is found to be associated with profound negative subsequent decline on both functioning and cognition. While epidemiological studies reported high prevalence in older population, its symptoms are often overlooked in the presence of other age-related diseases in the community as well as among the health professionals. It is expected that cognitive and functional disabilities secondary to this condition will pose a significant burden to the existing healthcare system. Therefore, targeting anxious older adults for early intervention may help to cut healthcare costs and to ensure proactive dementia prevention in the long run. The current proposed intervention intends to attenuate the trajectory of cognitive decline at a very early stage and enhance existing cognitive function to delay the onset of dementia.
This study aims to explore whether the use of integrated attention training program (IATP) could improve cognitive performance and functioning in older adults with anxiety symptoms. In particulars, we aim
- To examine the cognitive effect of 4 week integrated attention training program (I) and health education (C) in older adults with anxiety symptoms.
- To examine the 4 week integrated attention training program (I) and health education (C) in alleviating mood symptoms in older adults with anxiety symptoms.
- To examine the acceptability and adherence of the proposed intervention.
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 (Participant)
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 - 90 years; and
- •Presence of subjective memory complaints as measured by memory inventory for the Chinese; and
- •Anxiety symptoms as measured by Hamilton Anxiety Scale (HAM-A) with a score of 18 or above (indicated as mild anxiety symptoms).
排除标准
- •DSM-5 diagnosis of either Major Neurocognitive Disorder due to AD, or Major Vascular Neurocognitive Disorder with small vessel disease. This would include satisfying criteria for significant cognitive decline in at least one of six areas of cognition (memory, perceptual-motor, complex attention, language, executive function and social cognition), and with clinical or neuroimaging features indicative of either AD or small vessel disease; or;
- •Clinical dementia rating larger than or equal to 0.5; or
- •Clinically depressed as assessed by Hamilton Depression Rating Scale with a score of 20 or higher; or
- •Past history of major depressive episode, bipolar affective disorders or psychosis; or
- •Physical frailty that may affect attendance to training sessions; or
- •Currently on psychotropic or other medications know to affect cognition (e.g., benzodiazepines, anti-dementia medication, etc.); or
- •Participants in other cognitive training or intervention for brain health during the study period; or
- •Presence of major neurological deficit including history of stroke, transient ischemic attack or traumatic brain injury; or
- •Significant communicative impairment.
研究组 & 干预措施
Integrated Attention Training Program
The intervention group (I) will receive "integrated attention training program (IATP)" on a variety of structured attention tasks by an intervention instructor. It is considered to be simple and safe but effective enough for cognitive health promotion.
干预措施: Integrated Attention Training Program (IATP) (Other)
Health Education
The control group (C) will receive health educational sessions on health concerns and physical diseases commonly found in old age during the invention period.
干预措施: Health Education (Other)
结局指标
主要结局
Attention network test (ANT)
时间窗: T1: baseline, T2: 4th week, T3:12th week
ANT will measure the changes in attention from baseline to endpoint between the intervention and control groups. Performance was based on (i) accuracy refers to the degree of correctness and also to quality control, which means that if the participant's accuracy fell below 70%, the case would be considered unqualified. (2) reaction time refers to the processing speed. Median values of RT will be used as raw scores to avoid the influence of outliers. The indices will be served to compare the effect of IATP and health education.
次要结局
- Hamilton Depression Scale (HAM-D)(T1: baseline, T2: 4th week, T3:12th week)
- Clinical Dementia Rating (CDR)(T1: baseline, T2: 4th week, T3:12th week)
- Digit and visual spans(T1: baseline, T2: 4th week, T3:12th week)
- Category verbal fluency tests(T1: baseline, T2: 4th week, T3:12th week)
- The Chinese Neuropsychiatric Inventory (CNPI)(T1: baseline, T2: 4th week, T3:12th week)
- The Disability Assessment for Dementia (DAD)(T1: baseline, T2: 4th week, T3:12th week)
- Trail making tests(T1: baseline, T2: 4th week, T3:12th week)
- Hong Kong - Montreal Cognitive Assessment(T1: baseline, T2: 4th week, T3:12th week)
- Subjective memory complaints (SMC)(T1: baseline, T2: 4th week, T3:12th week)
- Delayed recall(T1: baseline, T2: 4th week, T3:12th week)
- Hamilton Anxiety Scale (HAM-A)(T1: baseline, T2: 4th week, T3:12th week)
- Lifestyle activity participation questionnaire(T1: baseline, T2: 4th week, T3:12th week)
研究者
Ada Wai Tung FUNG
Assistant Professor
The Hong Kong Polytechnic University