Computerized Cognitive Training for Schizophrenia in Brazil (CCTSB)

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Computerized cognitive training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21941590
      • Recruiting
      • Federal University of Rio de Janeiro
      • Contact: Linda Scoriels, Ph.D.; Phone Number: +552139385588; Email: lindascor@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Investigators: Principal Investigator: Rogerio Panizzutti, M.D., Ph.D., Universidade Federal do Rio de Janeiro

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: cognitive training
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 1R03TW009002-01 (U.S. NIH Grant/Contract)