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临床试验/NCT05506852
NCT05506852已完成不适用

Training Executive Control in Cognitively Healthy Aging: the Web-based Breakfast Game

Columbia University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2023年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Changes in the Breakfast Game Performance: Number of Tables Set Score

研究概览

简要总结

Executive control processes involve initiate, coordinate, synchronize, and regulate elemental cognitive functions for the conduct of goal-directed behavior. The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control processes will improve cognitive performance in cognitively healthy older adults.

详细描述

The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control / multi-tasking abilities will improve cognitive performance in healthy older adults. Cognitively normal adults aged 60-75 will be randomized into two experimental groups: 1) Web-based game with training strategy; 2) Web-based game without training strategy (Active Control). All participants (groups 1 and 2) will be instructed to play the complex, high-demand online game, Breakfast Game, for 14 one-hour sessions over 5 weeks.

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
Single (Participant)

盲法说明

Participants will not be aware of the difference across the two conditions.

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60-75
  • Willingness to adhere to training protocol
  • Adequate English proficiency

排除标准

  • Low test scores (below 26 on the Montreal Cognitive Assessment)
  • Known history of cognitive impairment, dementia, stroke, seizure disorder, or other neuropsychiatric condition judged to impact cognitive performance.
  • Taking medications known to influence cognitive performance.
  • Sensory (e.g. visual, auditory) or physical (e.g. severe arthritic, orthopedic, neurologic) impairment incompatible with use of a standard computer workstation.
  • Enrolled in a concurrent study that could affect the outcome of this study.

研究组 & 干预措施

Strategy Training

Experimental

Participants will play the Breakfast Game with training strategy.

干预措施: Web-based training strategy (Behavioral)

Regular Approach

Active Comparator

Participants will play the Breakfast Game without training strategy.

干预措施: Web-based regular training (no strategy) (Behavioral)

结局指标

主要结局

Changes in the Breakfast Game Performance: Number of Tables Set Score

时间窗: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12

Change in the total number of tables set. In the computerized task, participants are asked to set tables for four guests. When finished, one point is given. Higher scores represent a better outcome. This metric represents a change in the score = the higher means improvement in the performance. The total score ranges between 0 and 12; the total change score ranged from -3 to +3.

Changes in the Breakfast Game Performance: Cooking Time Range of Stop Times Scores

时间窗: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12

Change in cooking time (milliseconds) between food items. In the computerized task, participants are asked to cook different food types. Scores reflect the difference between the first and last food item that was stopped cooking. Lower scores (closest to zero) represent a better outcome. This metric represents a change in the score = the lower means improvement on the performance. The total score ranges between 0.3 and 315; the total change score ranges from -40 to +40.

Change in Breakfast Game Performance: Cooking Time Discrepancy Scores

时间窗: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12

Change in cooking time (milliseconds) in each food type. In the computerized task, participants are asked to cook different food types. Scores reflect the average absolute values of the difference between the required and actual cooking time of each item. Lower scores (closest to zero) represent a better outcome. This metric represents a change in the score = the lower means improvement in the performance. The total score ranges between 0.3 and 175; The total change score ranges from -20 to +20.

Transfer to Complex Executive/Attention Control Measure (Proximal Outcome).

时间窗: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)

Accuracy on the Alphanumeric Task. This metric represents a change in the score. The higher the means more improvement in the performance. The total change score ranged from -0.1 to +0.1

次要结局

  • Transfer to Executive Functions Composite Z-Score (Distal Outcome)(Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training))
  • Transfer to the General Self-efficacy Scale (Distal Outcome)(Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training))
  • Transfer to Beck Depression Inventory (Distal Outcome)(Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training))
  • Transfer to Beck Anxiety Inventory (Distal Outcome)(Within the 2 weeks before intervention starts, and the 6th week, after the last (13th) training session. (Measure represent the change between pre and post training))
  • Transfer to Cognition-Leisure Questionnaire (Distal Outcome)(Within the 2 weeks before intervention starts, and the 6th week, after the last (12th) training session. (Measure represent the change between pre and post training))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharon Sanz Simon

Principal Investigator

Columbia University

研究点 (1)

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