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临床试验/NCT02478827
NCT02478827已完成不适用

A Trial of Cognitive Training in Schizophrenia

University of Calgary4 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2016年3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
已完成
入组人数
83
试验地点
4
主要终点
Fluid intelligence

研究概览

简要总结

Schizophrenia is associated with a wide range of symptoms impacting a number of different domains, including cognitive impairment. Given the array of cognitive deficits associated with schizophrenia and their relationship to daily functioning, numerous research groups have examined the impact of cognitive remediation on many aspects of cognition. However, it is currently unclear as to which domains of cognition should be targeted to produce the most widespread and durable benefits for schizophrenia patients. It may be the case that targeting lower-level cognitive processes that are important for higher-level and more complex aspects of cognition may produce the most widespread benefits in cognition and everyday functioning. Relatively few studies have examined the effects of working memory or processing speed training on individuals with schizophrenia, as most studies examine broad-based remediation programs. Thus, there is a need for targeted working memory and processing speed training studies to better understand the mechanisms of cognitive enhancement through training in patients. This study will aim to: 1) investigate near-transfer gains associated with working memory and processing speed training in schizophrenia patients, 2) investigate far-transfer gains associated with working memory and processing speed training (i.e., gains in other neurocognitive domains and social cognition), and 3) investigate real-world gains associated with training (i.e., gains in daily functioning). Towards this aim, 81 schizophrenia patients will be recruited and randomly assigned to a working memory training group, a processing speed training group, or a no training control group. Training will be completed at home for 30 minutes per day, 5 days per week, for a total of 10 weeks. Neurocognitive, social cognitive, and daily functioning measures will be administered both pre- and post-training to detect training-related gains.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • Age between 18 and 65 years
  • A diagnosis of schizophrenia or schizoaffective disorder
  • Minimum IQ of 70
  • No uncorrected visual impairment, including colour blindness
  • No uncorrected hearing impairment
  • Able to provide informed consent

排除标准

  • Meeting Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) diagnostic criteria for a current major depressive episode, manic episode, or hypomanic episode
  • Past 1 month history of electroconvulsive therapy (ECT)
  • Past 1 month history of Transcranial Magnetic Stimulation therapy (TMS)
  • Past 3 month history of substance abuse
  • Diagnosed with a medical condition known to affect cognition (e.g., endocrine disease)
  • Score less than 70 on the Wechsler Abbreviated Scale of Intelligence (WASI)

研究组 & 干预措施

Control group

No Intervention

The control group will wait 10-weeks, during which they will receive treatment-as-usual (TAU), which might involve pharmacotherapy, psychotherapy, or both. After the 10-week waiting period, a post-assessment will be completed.

Working Memory group

Experimental

The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). Users will receive an account where they will only have access to the training games they have been assigned to and where their activity will be logged. One experimental group will complete the working memory training, which involves three games: N-back, Multi-Memory, and Moving Memory. These games are designed to engage processes involving updating and manipulation of information. All of the training games are adaptive. Participants randomized to this cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.

干预措施: Cognitive training (Behavioral)

Processing Speed group

Experimental

The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). Users will receive an account where they will only have access to the training games they have been assigned to and where their activity will be logged. One experimental group will complete the processing speed training, which involves three games: Line It Up, Sliding Search, and Bubble Math. These games are designed to engage processes involving thinking speed. Participants randomized to this cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks

干预措施: Cognitive training (Behavioral)

结局指标

主要结局

Fluid intelligence

时间窗: Change from baseline to post-assessment (after 10 weeks of training)

Measured with Raven's Standard Progressive Matrices and Cattell's Culture Fair Test

Working Memory

时间窗: Change from baseline to post-assessment (after 10 weeks of training)

Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span, Spatial Maintenance and Manipulation Task, and Visual N-Back Task

Processing Speed

时间窗: Change from baseline to post-assessment (after 10 weeks of training)

Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Symbol Search and Delis-Kaplan Executive Function System (D-KEFS) Color Naming Task

次要结局

  • Executive functions: categorization, set-shifting, and cognitive flexibility(Change from baseline to post-assessment (after 10 weeks of training))
  • Behavioural Impulsivity(Change from baseline to post-assessment (after 10 weeks of training))

研究者

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

Vina M. Goghari

Dr. Vina Goghari

University of Calgary

研究点 (4)

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