Research Project
9264781
DESCRIPTION (provided by applicant): The goal of the current project is to revise a prototype of a computerized, web-deliverable, social cognition training program (SocialVille) for schizophrenia completed in Phase I, and conduct a multi-site, randomized, controlled trial to establish efficacy in this population. Individuals with schizophrenia have severely degraded functional abilities and extremely poor life outcomes. These poor outcomes are strongly associated with pervasive deficits in social cognition: the difficulty in perception, interpretatio and processing of social information. Social cognition deficits not only underlie social functionin in schizophrenia, but also importantly affect occupational status, relapse rate, and overall qualit of life. This makes social cognition recovery a key goal for therapeutic interventions in schizophrenia. Despite the great need, there is currently no well-accepted or even broadly-administered method for improving social cognitive function in this large patient group. SocialVille was constructed to meet this need. In the Phase I project, we have developed SocialVille as a web-deliverable tool targeting the core domains of social cognition deficits in schizophrenia. SocialVille was designed to be clinician-prescribed and monitored, using a dedicated, state-of-the-art clinician portal. Our Phase I studies provided strong evidence for the feasibility of SocialVille in schizophrenia, as well as promising initial efficacy data showing significant improvements in social cognition, social function, motivation and source memory following SocialVille training, accompanied by neural-level changes in social brain areas. The successful completion of the Phase II project should provide rigorous efficacy data of the effects of SocialVille on social cognition and functional capacity (co-primary outcomes), and on functional outcome, quality of life and motivation (secondary outcomes). This outcomes data should be sufficient for submission to the FDA for clearance as a medical device indicated for the treatment of social cognition and related real-world functional abilities in schizophrenia. The resulting product, to be commercialized as the first online, clinician- monitored therapy for socia cognitive deficits, will therefore provide a cost-effective and highly-scalable treatment option fo this largely unmet clinical need, easily integrated into current health-care ecosystem in schizophrenia. As such, it is expected to help relieve the societal, functional, and economic burden associated with this devastating illness.
