Mechanisms of Cognitive Change (CTCS)
2022年9月21日 更新者：Michael L Thomas、Colorado State University
This study will determine whether targeted cognitive training, a low-cost and low-risk commercial cognitive remediation therapy, directly impacts therapeutic targets as well as secondary outcomes in college undergraduates.
The active intervention will be compared to an active control condition (computer games).
Participants will also attend CSU TILT (The Institute for Teaching and Learning) Academic Workshops.
研究概览
详细说明
The primary goal of this project is to investigate whether commercial cognitive remediation therapy improves cognitive functioning in college undergraduates.
The secondary goal is to investigate neurophysiological, cognitive, and psychosocial mechanisms of change.
The investigators will compare cognitive remediation therapy to computer games.
The active control condition will allow the investigators to determine whether targeted cognitive training, as an adjunct to academic skills training provided by CSU TILT, provides significant improvement over computer games alone (which is also thought to provide some value as "brain training").
Participants who agree to enroll in the study will be randomized to one of two intervention arms: cognitive remediation (CR) or active control (AC).
In the CR arm, participants will complete 20 hours of targeted cognitive training, in 30-min session, 5 days per week, over 8 weeks.
The AC Arm will follow the same schedule, except that participants will complete video games (e.g., pong).
All participants will repeat assessments at randomly determined midpoint, as well as after the 8 weeks of training have been completed.
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Colorado
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Fort Collins、Colorado、美国、80523
- Colorado State University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
15年 至 100年 (孩子、成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- College undergraduate;
- English fluency, and the ability to complete study requirements.
Exclusion Criteria:
- College seniors (i.e., students with more than 89 credits at CSU);
- Students who are concurrently enrolled in another study investigating the efficacy or effectiveness of novel learning or cognitive development techniques (not including tutoring or other existing programs available to CSU undergraduates);
- Participants less than age 15.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Cognitive Remediation
Cognitive Remediation comprises of six exercises supplied by BrainHQ by Posit Science Corporation: Sound Sweeps (targets auditory processing speed): Two successive frequency-modulated tone sweeps are presented and participants indicate whether the frequency increased or decreased within each tone: Fine Tuning (targets auditory perception and processing speed): Participants indicate which one of two confusable syllables were presented; Syllable Stacks (targets auditory memory); Users report the order of presented syllables in a serial memory span task; Memory Grid (targets auditory memory); Participants match identical cards representing syllables; To do List Training (targets auditory memory): Participants see a g rid of everyday items (e.g., plant, carrots, shovel) and select the items in accordance with spoken instructions; Rhythm Recall (target auditory memory): Participants recreate auditory melodies
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See Cognitive Remediation Arm description.
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有源比较器：Active Control
Active Control Comprises six exercises also supplied by Post Science Corporation: A Maze Race, Reversi, Bricks Breaking Hex, Word Search II, Bricks Squasher II, and CircloO.
These are all common computer games freely offered online.
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See Active Control Arm description.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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MATRICS Consensus Cognitive Battery (MCCB) Verbal Learning Subscale Scores
大体时间：Three time points (1 week pre-randomization, mid-treatment [randomly selected for each participant between the 2nd and 7th week of treatment], and 1 week post-treatment) for all participants.
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Change in MATRICS Consensus Cognitive Battery (MCCB) Verbal Learning Subscale.
Demographically corrected T-scores (M = 50; SD = 10; higher better).
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Three time points (1 week pre-randomization, mid-treatment [randomly selected for each participant between the 2nd and 7th week of treatment], and 1 week post-treatment) for all participants.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Academic Performance
大体时间：Semester data obtained yearly up to 8 years
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Academic performance will be evaluated using participant grade point average improvement over the course of the study.
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Semester data obtained yearly up to 8 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年9月20日
初级完成 (实际的)
2021年1月22日
研究完成 (实际的)
2021年1月22日
研究注册日期
首次提交
2019年9月20日
首先提交符合 QC 标准的
2019年9月24日
首次发布 (实际的)
2019年9月25日
研究记录更新
最后更新发布 (实际的)
2022年9月22日
上次提交的符合 QC 标准的更新
2022年9月21日
最后验证
2022年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 19-8509H
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.