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

Description

PROJECT SUMMARY The goal of this project is to further developto pivotal trial readinessand evaluate WASABIWiring Adolescents With Social Anxiety via Behavioral Interventionsa clinician assistedadjunct to treatmentmobile application designed to augment the efficacy of psychological Evidence Based Treatments through a closed loop technologyIn this projectwe will build upon promising results obtained from two studies in anxiety and psychosisleverage pilot data collected in adolescents with Social AnxietySAand test WASABI as an adjunct to digital Cognitive Behavioral Group TherapydCBGTVia Ecological Momentary AssessmentsEMAsWASABI will capture data on social anxietyits underlying cognitive biasesand on social role performanceThese data will populate a predictive machine learning algorithm that will alert the WASABI clinician and enduser of whenever social anxiety reaches clinical significanceThe clinician will use this information to initiate synchronous or asynchronous Instant MessagingIMbased conversations with the goal of supportingrecommending and reinforcing relevant skills to alleviate the momentary distressto increase social competenceand or to improve contextual social role performanceSimilarlythe clinician will leverage WASABI data to personalize dCBGT content during the weekly group video callsThis individualized assessmentmonitoringand treatment approach is posited to induce flexible adaptive long term learning about social emotional eventsand support the generalization of trained cognitive skills within the everyday lives of adolescentsthus improving their clinical and functional statusIn Specific Aimwe will first involve three adolescents with SA and two clinicians in three focus groups that will be organized to refine WASABI and qualitatively evaluate its manageabilityclinical usefulnessand acceptabilityOnce decisions regarding the app and dashboard design are madethe three adolescents will be involved in aweek trial runduring which the predictive ability of the algorithm will be validated by the WASABI clinicianwho will verify viaremote videocalls the actual presence of clinically significant social anxiety whenever she receives an alertAdditionallythe test run will ensure that WASABI EMA data are timely evaluated by the clinician on the dashboard and meaningfully orient the delivery of individualized IM and weekly dCBGT contentAt the end of this test runeach stakeholder will be asked to rate enjoymentease of useproduct qualityand perceived usefulnessFinallywe will submit these data from the trial run to our consultant to confirm that WASABI is suitable for evaluation in the feasibility trialIn Specific Aimto evaluate the acceptability and preliminary efficacy of WASABIwe will conduct a pilot augmentation trial withadolescents with SA who will be randomized to dCBGT WASABI vs dCBGT onlyAt the completion of this project we will have usability data sufficient to support a RCT in Phase II designed to establish medical claims defining the efficacy of this interventionAt the completion of Phase IIwe will be able to complete the FDA regulatory pathway and have the opportunity to improve the lives of people suffering from this condition PROJECT NARRATIVE The goal of the current project is to elaborate uponreconstruct and advance to pivotal trial readiness WASABIWiring Adolescents With Social Anxiety via Behavioral Interventionsa clinician assistedadjunct to treatmentmobile application designed to augment the efficacy of psychological evidence based treatmentsBy processing Ecological Momentary Assessments data collected from mobile devicesthe WASABI closed loop algorithm detects exacerbation of social anxietyand cuesand group based Instant Messaging with peers and providersIn this Phase I trialwe will test WASABI as an adjunct to digital Cognitive Behavioral Group Therapy in adolescents with Social Anxietywith the goal of promoting the generalization of trained cognitive skills in the natural environmentthus improving anxiety and social functioning