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Computerized Cognitive Training for Schizophrenia in Brazil

Computerized Cognitive Training for Schizophrenia in Brazil

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02591498
Acronym
CCTSB
Enrollment
100
Registered
2015-10-29
Start date
2014-01-31
Completion date
2019-12-31
Last updated
2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

cognitive training

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.

Interventions

BEHAVIORALComputerized cognitive training

Sponsors

Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Global cognition score changethrough study completion, an average of 1 yearThe global cognition score is a composite measure from the MATRICS (Measurement And Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery tests

Secondary

MeasureTime frameDescription
Processing speed score changethrough study completion, an average of 1 yearProcessing speed score will be measured using the Motor task from CANTAB (Cambridge Neuropsychological Test Automated Battery) test and the category fluency
Attention score changethrough study completion, an average of 1 yearAttention score will be measured using the Reaction time test and Rapid visual processing CANTAB tests
Working memory score changethrough study completion, an average of 1 yearWorking memory will be measured using the Spatial working memory CANTAB test and the digit backward
Verbal memory and learning score changethrough study completion, an average of 1 yearVerbal memory and learning score will be measured using the Hopkins verbal learning test
Visuospatial memory and learning score changethrough study completion, an average of 1 yearVisuospatial memory and learning score will be measured using the brief visuospatial memory test
Reasoning and problem solving score changethrough study completion, an average of 1 yearReasoning and problem solving score will be measured using the Stockings of Cambridge CANTAB test
Reward task score changethrough study completion, an average of 1 yearReward task score will be measured using the reward task (adapted from Graham Murray)
Emotional inhibition control score changethrough study completion, an average of 1 yearEmotional inhibition control score will be measured using the Affective go no go CANTAB test
Biological markers from the glutamatergic system changethrough study completion, an average of 1 yearBiological markers from the glutamatergic system will be measured using High profile liquid chromatography
Genes of neuroplasticitythrough study completion, an average of 1 yearGenes of neuroplasticity will be measured using candidate genotyping and Genome wide analysis
Eotaxin 1 changethrough study completion, an average of 1 yearLevels of eotaxin 1 will be measured using ELISA kit
Prepulse inhibition changethrough study completion, an average of 1 yearPrepulse inhibition will be measured via eye muscle reaction to sound
Eye-tracking changethrough study completion, an average of 1 yearEye-tracking will be measured via an infrared camera while patients do cognitive tests
Electroencephalogram (EEG) changethrough study completion, an average of 1 yearEEG will be measured with electrodes on the surface of the skull while patients do cognitive tests
motivation scores changethrough study completion, an average of 1 yearMotivation scores will be measured with an interview and the Behavior Inhibition/Activation Scale questionnaire
Depression score changethrough study completion, an average of 1 yearDepression score will be measured using the Hamilton - Depression questionnaire
Anxiety score changethrough study completion, an average of 1 yearDepression score will be measured using the Hamilton - Anxiety questionnaire
Mood scores changethrough study completion, an average of 1 yearmood scores will be measured using the Visual analogue scale (Norris 1971)
Positive and negative syndrome scale score changethrough study completion, an average of 1 yearClinical score will be measured using the Positive and Negative Syndrome Scale for Schizophrenia
Quality of Life changethrough study completion, an average of 1 yearQuality of life will be measured using the World Health Organization of quality of life

Countries

Brazil

Contacts

Primary ContactRogerio Panizzutti, M.D., Ph.D.
rogerio@icb.ufrj.br+552139386390
Backup ContactLinda Scoriels, Ph.D.
lindascor@yahoo.fr+552139385588

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026