Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
研究概览
详细说明
Participation in this study will last approximately 12 months and will involve individuals with recent-onset schizophrenia. All participants will undergo baseline assessments that will include an interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic resonance imaging (MRI) scans. Participants will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Participants will be asked to complete 60-minute sessions of their assigned treatments 5 days per week for 8 weeks. For participants receiving cognitive training, exercises will focus on improving speed and accuracy in the perception of and response to verbal and visuospatial targets. The 8 weeks of treatment will focus on targeted cognitive training (TCT). Participants assigned to practice computer games will play standard commercially available games, with no targeted response.
Participants will repeat baseline assessments after the computer training and Month 6 of follow-up. The EEG and MRI will be repeated only at post training assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, participants in the control condition will be offered an opportunity to complete an additional 8 weeks of computer training with different modules.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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California
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Sacramento、California、美国、95817
- University of California, Davis
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San Francisco、California、美国、94143
- University of California, San Francisco
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
- First psychotic episode within the last 3 years
- Good general physical health
- Age between 12-35
- Is fluent and proficient in the English language
- Achieved clinical stability (e.g., outpatient status for at least 3 months before study entry; on stable doses of medication for at least 1 month before study entry
- Minors must have parental/legal guardian consent to participate
Exclusion Criteria:
- Any neurological disorder
- History of psychoactive substance abuse in the past 6 months
学习计划
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:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:1
Participants will use commercially available computer games.
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The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 16 weeks.
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实验性的:2
Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
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神经适应性认知训练包括认知矫正练习,参与者每天练习 1 小时,每周练习 5 天,持续 8 周。
这些练习专门设计用于提高对语言目标的感知和反应的速度和准确性。
治疗将集中于TCT。
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有源比较器:3
Healthy participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
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神经适应性认知训练包括认知矫正练习,参与者每天练习 1 小时,每周练习 5 天,持续 8 周。
这些练习专门设计用于提高对语言目标的感知和反应的速度和准确性。
治疗将集中于TCT。
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Cognitive Performance, as measured by a neuropsychological battery
大体时间:Measured at Baseline, Week 8, and 6 Month Follow-Up
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Measured at Baseline, Week 8, and 6 Month Follow-Up
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次要结果测量
结果测量 |
大体时间 |
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Symptom profile, as measured by clinical interviews
大体时间:Measured at Baseline, Week 8, and 6 Month Follow-Up
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Measured at Baseline, Week 8, and 6 Month Follow-Up
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合作者和调查者
调查人员
- 首席研究员:Sophia Vinogradov, MD、University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research Institute
- 研究主任:Rachel Loewy, PhD、University of California, San Francisco
- 研究主任:Cameron Carter, MD、University of California, Davis
出版物和有用的链接
一般刊物
- Biagianti B, Fisher M, Neilands TB, Loewy R, Vinogradov S. Engagement with the auditory processing system during targeted auditory cognitive training mediates changes in cognitive outcomes in individuals with schizophrenia. Neuropsychology. 2016 Nov;30(8):998-1008. doi: 10.1037/neu0000311. Epub 2016 Sep 12.
- Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
- Puig O, Fisher M, Loewy R, Miley K, Ramsay IS, Carter CS, Ragland JD, Niendam T, Vinogradov S. Early- Versus Adult-Onset Schizophrenia as a Predictor of Response to Neuroscience-Informed Cognitive Training. J Clin Psychiatry. 2020 Mar 3;81(2):18m12369. doi: 10.4088/JCP.18m12369.
- Panizzutti R, Hamilton SP, Vinogradov S. Genetic correlate of cognitive training response in schizophrenia. Neuropharmacology. 2013 Jan;64(1):264-7. doi: 10.1016/j.neuropharm.2012.07.048. Epub 2012 Aug 7.
- Roach BJ, Ford JM, Biagianti B, Hamilton HK, Ramsay IS, Fisher M, Loewy R, Vinogradov S, Mathalon DH. Efference copy/corollary discharge function and targeted cognitive training in patients with schizophrenia. Int J Psychophysiol. 2019 Nov;145:91-98. doi: 10.1016/j.ijpsycho.2018.12.015. Epub 2018 Dec 29.
- Biagianti B, Roach BJ, Fisher M, Loewy R, Ford JM, Vinogradov S, Mathalon DH. Trait aspects of auditory mismatch negativity predict response to auditory training in individuals with early illness schizophrenia. Neuropsychiatr Electrophysiol. 2017;3:2. doi: 10.1186/s40810-017-0024-9. Epub 2017 Jun 9.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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神经适应性认知训练的临床试验
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Karolinska InstitutetMinistry of Health and Social Affairs, Sweden完全的
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Mental Health Services in the Capital Region, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention Research; Center for Clinical Intervention...完全的