Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia

Study Overview
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Brief Summary
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The aim of this study is to investigate the efficacy of neuroscience-guided computerized cognitive training exercises on the remediation of cognitive deficits and symptoms associated with recent-onset schizophrenia and to examine the influence of subject characteristics, brain structure and function, and pharmacotherapy on the response to remediation.

Detailed Description
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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.

Official Title
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Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Neuroadaptive cognitive training
* Behavioral: Computer games


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 35 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Participants will use commercially available computer games. | Behavioral: Computer games<br>* The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 16 weeks.<br>|
| Experimental: 2<br>Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation. | Behavioral: Neuroadaptive cognitive training<br>* Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.<br>|
| Active Comparator: 3<br>Healthy participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation. | Behavioral: Neuroadaptive cognitive training<br>* Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Performance, as measured by a neuropsychological battery |  | Measured at Baseline, Week 8, and 6 Month Follow-Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom profile, as measured by clinical interviews |  | Measured at Baseline, Week 8, and 6 Month Follow-Up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosis, First Episode, Schizophrenia, Cognitive Remediation