Computerized Cognitive Training for Schizophrenia in Brazil (CCTSB)

Universidade Federal do Rio de Janeiro

Status and phase: Unknown; Phase 3

Conditions: Schizophrenia

Treatments: Behavioral: Computerized cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT02591498

1R03TW009002-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 3 patient groups, including a placebo group

Auditory

Active Comparator group

Description:

Administration of 40 hours of auditory training exercises

Treatment:

Behavioral: Computerized cognitive training

Visual

Active Comparator group

Description:

Administration of 40 hours of visual training exercises

Treatment:

Behavioral: Computerized cognitive training

Video Games

Placebo Comparator group

Description:

Administration of 40 hours of commercial video games

Treatment:

Behavioral: Computerized cognitive training