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临床试验/NCT06375681
NCT06375681招募中不适用

Examining the Effectiveness of Cognitive Training

University of Wisconsin, Madison3 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,600
试验地点
3
主要终点
Change in the proportion of correctly reported number and letter sets in the Letter-Number task

研究概览

简要总结

The proposed study will enroll 1600 participants to examine the effectiveness of cognitive training. Participants will be randomized into different experimental groups and can expect to participate for up to 15 hours of research over 4 to 8 weeks.

详细描述

Participants will first complete two sessions (~75 minutes each) where they are asked to view visual stimuli (such as black and white lines, letters, simple shapes like triangles, circles, and squares) presented on a computer or television screen and/or listen to auditory stimuli (such as pure tones) presented via headphone or speakers. They will be asked to make some simple judgments about the stimuli (such as indicating whether the stimulus you observed is the same or different from that on a previous trial), and indicate their judgment decision with a button press on a keyboard, a mouse click, or a movement on a touchpad. They will also be asked to complete a set of questionnaires.

After the initial sessions, participants may be asked to complete two sets of 10 sessions (~20 minutes) of cognitive tasks either at home or in the lab. Each set of sessions should be completed over a period of no more than 15 days. If asked to do these sessions, instructions will be given regarding the tasks to complete in these training sessions (which will be similar to some of the tasks you complete in the first two sessions, ~20 minutes) prior to these sessions.

After completing the first set of 10 sessions, participants will complete, either at home or in the lab, one session (~75 minutes) of tasks similar to the first sessions. Participants who were not asked to complete the 20-minute sessions will complete another session two weeks after the first two 75-minute sessions in the same location as they completed the two 75-minute sessions.

Then, participants will complete the second set of ten 20-minute sessions, or wait for about two weeks for those not asked to complete the 20-minute sessions of cognitive tasks. After this, participants will complete two other sessions (~75 minutes) in the same location as they completed the previous two 75-mintue sessions.

Finally, after a couple of weeks, participants will complete their two final testing sessions (~45 minutes each) in the same location as they completed the previous two 75-mintue sessions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

盲法说明

All researchers that have contact with participants will be unaware of the tested hypothesis of the study.

Participants will be unaware of the experimental conditions.

Researchers and participants will be unaware (blinded) to the game conditions assigned to the participant, except for researchers in charge of supervising the training part of the study who will be aware what training the participant is undergoing.

More information on how this was achieved will be registered after data collection is completed to preserve the scientific integrity of the study.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Self-reported normal or corrected-to-normal vision
  • •No known neurological impairments
  • •Age within inclusion range (18-30 Years for Younger Adults and 60-85 Years for Older Adults)

排除标准

  • •Physical handicap (motor or perceptual) that would impede training procedures
  • •Concurrent enrollment in other cognitive training studies
  • •Not being proficient enough in English that would prevent following and understanding all instructions and completing all testing sessions (typically, participants would need to have learned English before age 11; there might be some exceptions that will be decided on a case-by-case basis).
  • •Unable to adhere to training schedule
  • •Additional exclusion criteria for older adults:
  • •- Score < 17 (out of 22) on the Telephone Montreal Cognitive Assessment (T-MoCA).

研究组 & 干预措施

Short Testing Group

Active Comparator

Participants will go through 2 assessment sessions over 2-3 days (~75 minutes each), followed by 1 session of 75 minutes about 2 weeks later, 2 further sessions (~75 minutes) over 2-3 days about 2 weeks after this session, and finally another 2 sessions (~45 minutes) 3 days to 2 weeks after that session. Sessions might take place either at home or in the lab.

干预措施: Visual and / or Auditory Cognitive Tasks (1) (Behavioral)

Long Testing Group

Active Comparator

Participants will go through 2 assessment sessions over 2-3 days (75 minutes each), followed by 10 sessions of cognitive tasks over 2 weeks, 1 session of 75 minutes about 2 weeks later, another 10 sessions of cognitive tasks over 2 weeks, then 2 sessions (~75 minutes) over 2-3 days about 2 weeks after this session, and finally another 2 sessions (~45 minutes) 3 days to 2 weeks after that session. Sessions might take place either at home or in the lab.

干预措施: Visual and / or Auditory Cognitive Tasks (1) (Behavioral)

Long Testing Group

Active Comparator

Participants will go through 2 assessment sessions over 2-3 days (75 minutes each), followed by 10 sessions of cognitive tasks over 2 weeks, 1 session of 75 minutes about 2 weeks later, another 10 sessions of cognitive tasks over 2 weeks, then 2 sessions (~75 minutes) over 2-3 days about 2 weeks after this session, and finally another 2 sessions (~45 minutes) 3 days to 2 weeks after that session. Sessions might take place either at home or in the lab.

干预措施: Visual and / or Auditory Cognitive Tasks (2) (Behavioral)

结局指标

主要结局

Change in the proportion of correctly reported number and letter sets in the Letter-Number task

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

The Letter-Number Sequence Task is a measure of working memory. In each trial, the participant is presented with a sequence of alternating letters and numbers, from 2 to 10 stimuli. Participants have to report the numbers in ascending order, and the letters in alphabetical order.

Change in the difference of response time in (i) switch trials minus non-switch trials and (ii) congruent minus incongruent trials in the Flanker Task

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

In the Flanker task, the participant is asked to indicate whether the centrally presented arrow is pointing either to the left or right by pressing the left or right triangular buttons. This arrow is surrounded by 4 identical arrows, 2 to its left and 2 to its right; these are called non-target arrows. The participant is presented with two different trial types during the task, incongruent and congruent. In the congruent trials, the non-target arrows point in the same direction as the target arrow (e.g. all to the left) and in the incongruent trials they point in the opposite direction (e.g. target to the right, non-targets to the left). Switch trials are trials preceded by a trial of the opposite category (i.e. congruent preceded by incongruent or incongruent preceded by congruent).

Change in the proportion of correctly identified targets in the mixed condition of the Cancellation task

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

The Cancellation task is a measure of cognitive flexibility. Participants are presented with rows of 8 stimuli that can be either cats or dogs. Each cat and dog varies along its orientation, color pattern, and/or stance, giving 4 distinct cats and 4 distinct dogs. One cat and one dog are targets, and the rest are distractors. The goal of the participant is to mark as many targets as possible within each row in the allotted time (210 seconds).

Change in the percentage of correct responses in the Paper Folding task

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

The Paper Folding task is a measure of mental rotation. Participants are shown 2-4 images depicting a piece of paper being folded with a hole being punched after the last fold. The participant is asked to imagine and indicate what the paper would look like unfolded. The participant will complete 10 trials.

Change in the difference of response time and accuracy in switch trials minus non-switch trials in the Task Switching Task

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

The Task Switching task is a measure of cognitive flexibility. On each trial, participants view a letter and a digit. A cue tells the participant to either categorize the letter as a consonant or vowel or else categorize the digit as even or odd. Trials can be either "non-switch trials" - in which the participant is asked to perform the same task as on the previous trial - or "switch trials" - in which the participant is asked to perform the opposite task as on the previous trial. The participant will complete 48 trials. A "switch cost" is calculated by subtracting the average response time for switch trials from the average response time for non-switch trials.

Change in the sum of correctly solved items in the UC Matrix Reasoning task

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

The UC Matrix Reasoning task is a measure of fluid intelligence. The participant is presented with a grid of elements with one of the elements missing and is asked to identify the missing element that completes the grid pattern. The participant will complete 16 trials.

Change in the percentage of accuracy in the Shipley Institute of Living Scale

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

Participants will complete Part I of the Shipley Institute of Living Scale, which is a measure of vocabulary. Participants are asked to select the appropriate synonym for a target word among several alternatives for 15 words.

Change in the difference between the proportion of hits minus false alarms for a given level of the N-back task

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

The n-Back Task is a measure of working memory. The participant is sequentially shown a series of letters and is asked to indicate whether the current letter matches the letter presented "n" items before. The n levels range between 1- and 4-back. Each level of n-back has 17-19 letters, with 5 target letters.

Change in the response time and percentage of correct responses in the Mental Rotation Task

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

The mental rotation task is a measure of spatial cognition. Each trial displays two 2-D images, and the participant is asked whether the image on the right is a rotated version or a mirror-reserved and rotated version of the image on the left. The participant will complete 36 trials.

Change in the sum of correctly solved items in Raven's Advanced Progressive Matrices task

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

Raven's Advanced Progressive Matrices task is a measure of fluid intelligence. The participant is presented with a grid of elements with one of the elements missing and is asked to identify the missing element that completes the grid pattern. The participant will complete 14 trials.

Change in the proportion of correct responses on the Useful Field of View (UFOV) Task

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

The UFOV is a measure of visual selective attention. Participants are briefly presented with a display consisting of 24 peripheral items (3 on each of the four radial spokes and the four obliques; evenly spaced) and 1 central stimulus (a smiley with either long or short hair). One of the peripheral items is a target, while the remaining items are distractors. The participants' task is to indicate upon which of the 8 spokes the target appeared, and whether the central smiley had short or long hair. The display times vary between 16-500ms.

Change in the proportion of correct responses on the Multiple Object Tracking (MOT) Task

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

The MOT is a measure of visual divided attention. On each trial, participants view a series of blue and yellow smiley faces randomly moving in circular area. After a few seconds, the blue faces become yellow, indistinguishable from the distractors, while all the items keep moving on the screen. After another period of a few seconds, the items stop, and the participant is asked whether a randomly selected face was initially blue or yellow at the beginning of the trial.

Change in the proportion of correctly reported sequences in the Corsi Complex task

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

The Corsi Complex Task is a measure of working memory. The participant is sequentially shown a series of positions from 12 possible predefined spots on the screen. Between each position, the participants is also asked to categorize a stimulus between two categories based on color and shape. The participant's task is to report the sequence of positions in order. The length of sequence can vary between 2 and 10.

Change in the percentage of accuracy in the Mill-Hill Vocabulary Scale

时间窗: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days

In this vocabulary task, participants are asked to select the appropriate synonym for a target word among several alternatives for 25 words.

次要结局

  • Big-5-Inventory 10-item version (BFI-10) Score(Pre-Test)
  • Behavioral Inhibition/Activation System (BIS/BAS) Score(Pre-Test)
  • Meta-Cognition Score(Pre-Test)
  • Grit and Conscientiousness Score(Pre-Test)
  • Theories of Intelligence - Mindset (Fixed vs Growth) Score(Pre-Test)
  • Schutte self-report emotional intelligence test (SSEIT) Score(Pre-Test)
  • Brief Pittsburgh Sleep Quality Index (B-PSQI) Score(Pre-Test)
  • Work and Family Orientation (WOFO) Score(Pre-Test)
  • Participant Experience Measure 2(End of Post-Test (up to 60 days))
  • Participant Experience Measure 3(End of Post-Test (up to 60 days))
  • Participant Experience Measure 1(End of Post-Test (up to 60 days))
  • Participant Experience Measure 5(Beginning of Post-Test (up to 60 days))
  • Participant Experience Measure 4(Beginning of Post-Test (up to 60 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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