POSIT SCIENCE CORP — Department of Health and Human Services SBIR Phase I: 104

Description

PROJECT SUMMARY ABSTRACT The goal of the current Phase I project is to developto clinical trial readinessand evaluate feasibility of a mobile ecological momentary intervention designed to improve social functioning in individuals with schizophreniaWhile effective treatments such as group based social skills training and computerized social cognition training are known to induce positive effects on lab based measures of socialcommunity and occupational functioningno approaches currently monitor and facilitate the generalization of acquired skills in real world settingsMobile technology offers many advantages over clinic based approachesin that it enables real time evaluationinteractionand support within the individualandapos s natural environmentthus facilitating skill transferAdditionallyit improves accessexpands reachand targets underserved vulnerable individuals who are unable to access these specialized programsIn our preliminary workwe developed and demonstrated the feasibility of a newly designed mobile psychosocial intervention called CLIMBCreating Live Interactions to Mitigate BarriersCLIMB integrates computerized social cognition training with optimized remote social skills trainingand is delivered entirely remotely using mobile platformsOur preliminary data suggest that CLIMB resulted in good retentionengagementand acceptability ratesand remediated social cognitive and quality of life impairmentsIn this proposalwe will first implement the current intervention with innovative featuresincluding ecological momentary assessmentsweekly self reportsinteractive training and evaluation modulesand a clinician dashboardNextwe will evaluate the acceptability and preliminary efficacy of the revised intervention with the target populationAt the completion of this project we will have outcomes data sufficient to support a large scale randomized controlled trial in Phase IImedical device trialdesigned to establish medical claims defining the efficacy of this intervention to enhance social functioning for schizophreniaAt the completion of Phase IIwe expect to be able to complete the FDA regulatory pathwayclear the program as the first technologybased medical device intended for the enhancement of social functioning in schizophreniaand have the opportunity to improve the lives of millions of people suffering from this condition Narrative The goal of this project is to further developto pivotal trial readinessand evaluate a mobile ecological momentary interventionCreating Live Interactions to Mitigate BarriersCLIMBdesigned to improve social functioning in individuals with schizophreniaThis intervention may benefit a large population of individuals with schizophrenia with poor social functioning who suffer from lack of viable and widely accessible treatment options!