Assessment and Training of Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 4
- 主要终点
- Change in N-level
研究概览
简要总结
The present study investigates how individual differences in cognitive processing contribute to the efficacy of working memory training programs in an older adult population. In a randomized crossover design, different types of working memory training interventions will be evaluated within the same participants.
Adding game-like elements to working memory training programs can increase motivation and engagement, which can increase learning. However this process, termed gamification, adds sensory complexity that can lead to increased mental load and/or distraction in older adults. Investigators hypothesize that gamification of training tasks will be beneficial to some and counterproductive to other participants. The investigators will test two models; the first assumes that participants with difficulty inhibiting distracting information will show better learning and transfer when assigned to non-gamified training, whereas those with more distractor tolerance will show better learning and transfer when assigned to gamified training. The second model states that the outcomes of the intervention will be better predicted by performance on measures of general cognitive ability.
In a separate study, the investigators will compare working memory training that contains rich, multisensory information with a training program that contains only visual information. Here they will also test two models; the first assumes that participants with difficulty binding two stimulus streams will show better learning and transfer when assigned to visual-only working memory training, whereas participants who do not have this difficulty will show better learning and transfer when assigned to multisensory working memory training. The second model states that the outcomes of the intervention will be better predicted by performance on measures of general cognitive ability.
详细描述
Three randomized cross-over trials will be conducted to obtain within-subject comparisons of training with enriched (game-like) versions of working memory training tasks compared to basic (non-gamified) versions of these tasks. In the N-back trial, participants will be assigned to Non-Gamified N-back training and Gamified N-back training. In the Span trial, they will be assigned to Non-Gamified Span training and Gamified Span training and in the Multisensory trial, they will be assigned to Non-gamified Unisensory N-back training and Non-gamified Multisensory N-back training.
Each trial involves a total of 50 sessions per participant: the first few sessions consist of completing questionnaires and computerized cognitive assessments (pre-test). Participants then complete 20 sessions of working memory training. After a mid-test, they complete 20 sessions of a different type of working memory training. Post-test is administered upon training completion, and at least a month later, participants complete 3 follow-up sessions. The study can be administered either in person or remotely; however, the investigators anticipate that most participants will complete the study remotely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50-85 years of age
- •Able to understand and speak English and follow study procedures
- •Does not have a psychological or neurological condition that would prevent being able to give consent to participate
- •Not currently involved in any other cognitive or memory training studies
排除标准
- •Formal diagnosis of dementia or other neurological disease, including Mild cognitive impairment.
- •A final total score below 17 on Montreal Cognitive Assessment - Blind (telephone) version.
- •Score of 10 or more on the Generalized Anxiety Questionnaire (GAD7; Spitzer et al., 2006, Archives of Internal Medicine), indicating presence of moderate or severe anxiety
- •Score of 9 or more on Geriatric depression scale (GDS15; Yesavage et al., 1982) indicating presence of moderate or severe depression
- •Abnormal visual acuity prohibitive of tablet-based training.
- •Physical handicap (motor or perceptual) that would impede training procedures.
- •Medical illness requiring treatment and/or significant absences during the study timeline.
- •Current evidence or 2-yr history of seizures, focal brain lesion, or head injury with loss of consciousness.
- •Current alcohol consumption exceeds 14 drinks per week.
- •Self-reported illicit drug use.
结局指标
主要结局
Change in N-level
时间窗: Day 24, Day 46, Day 78
N-back is a tablet-based updating working memory task. Participants see a consecutive stream of pictures and are asked to tap the pictures that match those presented N items earlier. All participants will complete 1-back and 2-back, progression to 3-back and beyond is based on performance on the previous level (no more than 4 errors). The outcome measure is the change in the highest N-level reached on the task compared to baseline at Day 2.
Change in Corsi span
时间窗: Day 25, Day 47, Day 79
Corsi is a tabled-based measure of spatial working memory. Participants see characters emerge one at a time from twelve possible locations and are asked to repeat the sequence by tapping on the locations in the correct order. The task starts with set size two and increases in difficulty using an adaptive algorithm. Participants first play Simple Corsi (without a distractor task), followed by Complex Corsi (with a distractor task). The outcome measure is change in overall span, calculated as the sum of the two highest set sizes that can be recalled in Simple and Complex Corsi tasks, at the point of measurement compared to baseline at Day 3.
Change in Inhibitory Control Composite Score
时间窗: Day 24, Day 46, Day 78
The score is the mean of standardized dependent variables on tablet-based inhibitory control tasks. The outcome measure is the change in the composite score at the point of measurement compared to baseline at Day 2.
Change in Everyday Memory Questionnaire Revised
时间窗: Day 24, Day 46, Day 77
The Everyday Memory Questionnaire Revised (Royle \& Lincoln, 2008) consists of 13 items that describe everyday events that might involve forgetting. Participants are asked how often on average they think each one has happened to them over the past month on a 5-point scale (0-4) and the total score is calculated as the sum of all responses. The minimum total score is 0 and the maximum is 52, with higher scores indicative of greater presence of memory difficulties. The outcome measure is the change in total score at the point of measurement compared to baseline at Day 1.
次要结局
- Training Experience Enjoyment Subscale I(Day 24)
- Training Experience Enjoyment Subscale II(Day 46)
- Training Experience Difficulty Subscale I(Day 24)
- Training Experience Difficulty Subscale II(Day 46)
- Training Experience Subjective Progress Subscale I(Day 24)
- Training Experience Subjective Progress Subscale II(Day 46)
- Training Experience Interface Subscale I(Day 24)
- Training Experience Interface Subscale II(Day 46)
- Exit Survey(Day 79)
研究者
Susanne Jaeggi
Assistant Project Scientist
Northeastern University