Computerized Cognitive Training for Schizophrenia in Brazil

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of a neuroplasticity-based computerized cognitive training for people with schizophrenia in the Brazilian population.

Detailed Description
-----------------
Cognitive impairments are important determinants of functional outcome in schizophrenia, which are inadequately treated by antipsychotic medication. Neuroplasticity based computerized cognitive trainings have been emerging for the last two decades and are an attempt to help patients with their cognitive impairments and global functioning. The aim of this study is to perform a computerized cognitive training to improve attention, concentration, learning, clinical symptoms and quality of life in patients. The investigators are interested in testing the differential efficacy between a specific visual versus auditory computerized cognitive training and explore the biological markers that may be involved in these neuroplasticity based training processes. The investigators will conduct a 40 hours computerized, adaptable, perception specific, cognitive training program in patients with schizophrenia. Patients will come for 1 hour, daily, and perform a visual or auditory training, or control games for about 2 months. Visual and auditory exercises are chosen to be the equivalent of one another and target cognitive domains such as divided attention, working memory and social cognition. Clinical, cognitive, emotional and biomarker data will be collected before the training, half way through, and after the training, to assess progress in several aspects of their functioning and biology. The investigators hypothesize visual and auditory trainings will be effective as compared to the control games. They also expect that auditory training to be more efficient compared to the visual training because it targets sensory functions that are mostly impaired in schizophrenia, due to auditory hallucinations patients experience. The investigators also hypothesize that both trainings will improve clinical symptoms and quality of life. On a more exploratory analysis, the investigators expect to identify new biological markers of cognitive neuroplasticity, which they expect will differentiate visual and auditory paths.

Official Title
-----------------
Computerized Cognitive Training for Schizophrenia in Brazil

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: Computerized cognitive training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV criteria age 18- 60 years Portuguese as primary language (learned before age 12) no major medical or neurological disorder that precludes participation in the study Exclusion Criteria: IQ score <70 active substance dependence (DSM-IV criteria)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Auditory<br>Administration of 40 hours of auditory training exercises | Behavioral: Computerized cognitive training<br> <br> |
| Active Comparator: Visual<br>Administration of 40 hours of visual training exercises | Behavioral: Computerized cognitive training<br> <br> |
| Placebo Comparator: Video Games<br>Administration of 40 hours of commercial video games | Behavioral: Computerized cognitive training<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global cognition score change | The global cognition score is a composite measure from the MATRICS (Measurement And Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery tests | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Processing speed score change | Processing speed score will be measured using the Motor task from CANTAB (Cambridge Neuropsychological Test Automated Battery) test and the category fluency | through study completion, an average of 1 year | 
| Attention score change | Attention score will be measured using the Reaction time test and Rapid visual processing CANTAB tests | through study completion, an average of 1 year | 
| Working memory score change | Working memory will be measured using the Spatial working memory CANTAB test and the digit backward | through study completion, an average of 1 year | 
| Verbal memory and learning score change | Verbal memory and learning score will be measured using the Hopkins verbal learning test | through study completion, an average of 1 year | 
| Visuospatial memory and learning score change | Visuospatial memory and learning score will be measured using the brief visuospatial memory test | through study completion, an average of 1 year | 
| Reasoning and problem solving score change | Reasoning and problem solving score will be measured using the Stockings of Cambridge CANTAB test | through study completion, an average of 1 year | 
| Reward task score change | Reward task score will be measured using the reward task (adapted from Graham Murray) | through study completion, an average of 1 year | 
| Emotional inhibition control score change | Emotional inhibition control score will be measured using the Affective go no go CANTAB test | through study completion, an average of 1 year | 
| Biological markers from the glutamatergic system change | Biological markers from the glutamatergic system will be measured using High profile liquid chromatography | through study completion, an average of 1 year | 
| Genes of neuroplasticity | Genes of neuroplasticity will be measured using candidate genotyping and Genome wide analysis | through study completion, an average of 1 year | 
| Eotaxin 1 change | Levels of eotaxin 1 will be measured using ELISA kit | through study completion, an average of 1 year | 
| Prepulse inhibition change | Prepulse inhibition will be measured via eye muscle reaction to sound | through study completion, an average of 1 year | 
| Eye-tracking change | Eye-tracking will be measured via an infrared camera while patients do cognitive tests | through study completion, an average of 1 year | 
| Electroencephalogram (EEG) change | EEG will be measured with electrodes on the surface of the skull while patients do cognitive tests | through study completion, an average of 1 year | 
| motivation scores change | Motivation scores will be measured with an interview and the Behavior Inhibition/Activation Scale questionnaire | through study completion, an average of 1 year | 
| Depression score change | Depression score will be measured using the Hamilton - Depression questionnaire | through study completion, an average of 1 year | 
| Anxiety score change | Depression score will be measured using the Hamilton - Anxiety questionnaire | through study completion, an average of 1 year | 
| Mood scores change | mood scores will be measured using the Visual analogue scale (Norris 1971) | through study completion, an average of 1 year | 
| Positive and negative syndrome scale score change | Clinical score will be measured using the Positive and Negative Syndrome Scale for Schizophrenia | through study completion, an average of 1 year | 
| Quality of Life change | Quality of life will be measured using the World Health Organization of quality of life | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive training