Phase 1 Study of Cognitive Activation Behavioral Therapy for MCI: A Randomized Waitlist-Control and Delayed Active-Control Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Executive Function
研究概览
简要总结
Mild cognitive impairment (MCI) describes an initial phase of cognitive decline, usually among older adults, in which a person notices a decline in attention or memory, and performs worse than normal on cognitive tests of such. People with MCI are more likely to develop Alzheimer's disease or related dementia than others their same age, and so MCI is thought of as an early warning sign of progressive cognitive decline.
While some forms of MCI may be brought about by purely genetic causes, other cases may be due to a withdrawal of cognitive engagement with the world. In these cases, a rigorous program of cognitive training may be beneficial, halting or reversing symptom progression.
The current study will evaluate a multifaceted cognitive activation program on older adults with MCI. This group program is intensive, running for 10 weeks, 3 times per week, for a total of 100 hours of training. Training consists of meditation exercises for broad attention activation, Tai Chi exercises to integrate cognition with body awareness, and cognitive training through computerized attention, memory, and problem solving exercise.
Subjective impressions and objective measures of cognitive ability will be measured before and after the intervention. The investigators will also examine effects on mood and levels of daily function. Results will be compared to a waitlisted control group. The control group will subsequently be entered into a home-based version of the program for 10 weeks, with assessment before and after training, to look at the importance of the group meeting dynamic in promoting cognitive change.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjective complaint about decline in memory or attention
- •> 1 deviation below age-norm performance on memory or attention tasks
- •Independence in daily living
- •English speaking
排除标准
- •Neurological disorders (including aphasias) or reversible causes of dementia (e.g., hypothyroidism or B12 deficiency)
- •Montreal Cognitive Assessment (MOCA) score < 24
- •Clinical mood disorder such as depression or anxiety
- •Other serious medical conditions that preclude participation in the program
研究组 & 干预措施
Waitlist Control / Home-based training
This group will serve as a waitlist control group while the active group is performing training. Following assessment at the end of the active group period, this group will begin home-based training and will be assessed at the end of that 10 week period.
干预措施: Waitlist Control / Home-based training (Behavioral)
Cognitive Activation Group
This group will attend the 3/week group intervention meetings over 10 weeks.
干预措施: Cogntive Activation Training (Behavioral)
结局指标
主要结局
Executive Function
时间窗: Before and After Intervention
Tests of inhibition, task switching, and problem solving.
Attention / Working Memory
时间窗: Before and after intervention
Working memory measures such as digit span, selection of targets among distractors, etc.
Processing Speed
时间窗: Before and After Intervention
Processing speed on computerized cognitive task.
Memory
时间窗: Before and After Intervention
Tests of immediate recall and delayed recall, recognition, and familiarity.
次要结局
- Daily Function(Before and after intervention)
- Mood and Well-being(Before and after intervention)
研究者
Norman Farb
Postdoctoral Fellow
Rotman Research Institute at Baycrest