A Trial of Cognitive Training in Schizophrenia

Study Overview
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Brief Summary
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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.

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Cognitive training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Working Memory group<br>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. | Behavioral: Cognitive training<br>* 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. Participants randomized one of the cognitive training arms will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.<br>|
| Experimental: Processing Speed group<br>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 | Behavioral: Cognitive training<br>* 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. Participants randomized one of the cognitive training arms will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid intelligence | Measured with Raven's Standard Progressive Matrices and Cattell's Culture Fair Test | Change from baseline to post-assessment (after 10 weeks of training) | 
| Working Memory | Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span, Spatial Maintenance and Manipulation Task, and Visual N-Back Task | Change from baseline to post-assessment (after 10 weeks of training) | 
| Processing Speed | Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Symbol Search and Delis-Kaplan Executive Function System (D-KEFS) Color Naming Task | Change from baseline to post-assessment (after 10 weeks of training) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive functions: categorization, set-shifting, and cognitive flexibility | Measured with Delis-Kaplan Executive Function System (D-KEFS) Color-Word Interference Test and Trail Making Test | Change from baseline to post-assessment (after 10 weeks of training) | 
| Behavioural Impulsivity | Measured with Delay Discounting Task | Change from baseline to post-assessment (after 10 weeks of training) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Training, Working Memory, Processing Speed