Mor Nahum - US grants

DESCRIPTION (provided by applicant): The primary objective of this Phase I proposal is to develop and evaluate a novel, brain-based and web-deliverable multimedia training program targeting the treatment of social cognition deficits in schizophrenia. Social cognition impairments have been directly linked to patients'overall dysfunctionality, poor community functioning, and reduced life quality in schizophrenia, making it an especially appealing target for clinical intervention. However, current available treatments could be substantially improved in terms of efficiency, cost, scalability, and the positive changes they generate in untrained, real-life gains. There is therefore an acute need for the development of an effective therapeutic tool that would substantially improve social cognition in schizophrenia. With its potential effect on almost every aspect of the lives of these individuals, such a tool is expected to relieve the societal, functional and economic burden associated with this devastating illness. The proposed new training tool is derived from several ongoing advances in brain research. Specifically, increased understanding in how to apply brain-based methods in behavioral training to drive substantial functional changes, new insights into the dysfunctional brain areas associated with social cognition deficits in schizophrenia, and compelling new results showing the important added value of targeted social cognition training, all set the ground for this proposed new intervention. Guided by these advances, we now innovatively propose to combine the learning strategies derived from brain training principles with state-of-the-art web- based techniques to build and validate a novel, computerized training tool, which directly targets the neurological deficits that are at the core of social cognition impairments in schizophrenia. The complete suite of training exercises is expected to take social cognition treatment for schizophrenia to the next level, by offering both substantially more functional rehabilitation (given the brain-based and complete nature of training), along with a scalable, cost-effective treatment (by web-based resources). Our goals in this SBIR Phase I proposal are to develop, produce and validate the usability and feasibility of this new training program suite, which should include 19 adaptive, playable, exercises, in individuals with schizophrenia. In the past year we have already initiated the development and testing of 11 of the 19 proposed training exercises: Results from two pilot studies we conducted show promising prospects for the remediation abilities of this novel therapeutic tool. Our longer-term aims for Phase II are to use the data obtained in Phase I to further optimize the training program and conduct a large-scale, multiple-site, randomized, controlled trial to establish the efficacy and evaluate the broader clinical impact of this innovative intervention. By the end of Phase II, we shall have our product ready for commercialization as a low-cost, clinician-monitored, web-based therapy for the remediation of social cognition and related real-world functional abilities that debilitate the lives of millions of individuals struggling with schizophrenia. PUBLIC HEALTH RELEVANCE: This proposal represents a direct contribution to human health in that it should result in the production of a novel, brain-based, computerized, and cost-effective training program for the treatment of social cognition deficits in individuals with schizophrenia. Positive improvements in social cognition are a crucial facet of restoring the health and life-quality of the millions of individuals suffering from this devastating illness. Millions of other individuals with social cognition deficits can be expected to ultimately benefit greatly from the development of this new form of medicine.

DESCRIPTION (provided by applicant): The primary objective of this Phase I proposal is to develop and evaluate a novel, brain-based and web-deliverable multimedia training program targeting the treatment of social cognition deficits in schizophrenia. Social cognition impairments have been directly linked to patients' overall dysfunctionality, poor community functioning, and reduced life quality in schizophrenia, making it an especially appealing target for clinical intervention. However, current available treatments could be substantially improved in terms of efficiency, cost, scalability, and the positive changes they generate in untrained, real-life gains. There is therefore an acute need for the development of an effective therapeutic tool that would substantially improve social cognition in schizophrenia. With its potential effect on almost every aspect of the lives of these individuals, such a tool is expected to relieve the societal, functional and economic burden associated with this devastating illness. The proposed new training tool is derived from several ongoing advances in brain research. Specifically, increased understanding in how to apply brain-based methods in behavioral training to drive substantial functional changes, new insights into the dysfunctional brain areas associated with social cognition deficits in schizophrenia, and compelling new results showing the important added value of targeted social cognition training, all set the ground for this proposed new intervention. Guided by these advances, we now innovatively propose to combine the learning strategies derived from brain training principles with state-of-the-art web- based techniques to build and validate a novel, computerized training tool, which directly targets the neurological deficits that are at the core of social cognition impairments in schizophrenia. The complete suite of training exercises is expected to take social cognition treatment for schizophrenia to the next level, by offering both substantially more functional rehabilitation (given the brain-based and complete nature of training), along with a scalable, cost-effective treatment (by web-based resources). Our goals in this SBIR Phase I proposal are to develop, produce and validate the usability and feasibility of this new training program suite, which should include 19 adaptive, playable, exercises, in individuals with schizophrenia. In the past year we have already initiated the development and testing of 11 of the 19 proposed training exercises: Results from two pilot studies we conducted show promising prospects for the remediation abilities of this novel therapeutic tool. Our longer-term aims for Phase II are to use the data obtained in Phase I to further optimize the training program and conduct a large-scale, multiple-site, randomized, controlled trial to establish the efficacy and evaluate the broader clinical impact of this innovative intervention. By the end of Phase II, we shall have our product ready for commercialization as a low-cost, clinician-monitored, web-based therapy for the remediation of social cognition and related real-world functional abilities that debilitate the lives of millions of individuals struggling with schizophrenia. PUBLIC HEALTH RELEVANCE: This proposal represents a direct contribution to human health in that it should result in the production of a novel, brain-based, computerized, and cost-effective training program for the treatment of social cognition deficits in individuals with schizophrenia. Positive improvements in social cognition are a crucial facet of restoring the health and life-quality of the millions of individuals suffering from this devastating illness. Millions of other individuals with social cognition deficits can be expected to ultimately benefit greatly from the development of this new form of medicine.

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.