The goal of this project is to further develop (to pivotal trial readiness) and evaluate WASABI (Wiring Adolescents With Social Anxiety via Behavioral Interventions)?a clinician-assisted, adjunct to treatment, mobile application designed to augment the efficacy of psychological Evidence Based Treatments through a closed-loop technology. In this project, we will build upon promising results obtained from two studies in anxiety and psychosis, leverage pilot data collected in adolescents with Social Anxiety (SA), and test WASABI as an adjunct to digital Cognitive Behavioral Group Therapy (dCBGT). Via Ecological Momentary Assessments (EMAs) WASABI will capture data on social anxiety, its underlying cognitive biases, and on social role performance. These data will populate a predictive machine learning algorithm that will alert the WASABI clinician and end- user of whenever social anxiety reaches clinical significance. The clinician will use this information to initiate synchronous or asynchronous Instant Messaging (IM)-based conversations with the goal of supporting, recommending and reinforcing relevant skills to alleviate the momentary distress, to increase social competence, and/or to improve contextual social role performance. Similarly, the clinician will leverage WASABI data to personalize dCBGT content during the weekly group video-calls. This individualized assessment, monitoring, and treatment approach is posited to induce flexible adaptive long-term learning about social-emotional events, and support the generalization of trained cognitive skills within the everyday lives of adolescents, thus improving their clinical and functional status.
In Specific Aim 1, we 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 manageability, clinical usefulness, and acceptability. Once decisions regarding the app and dashboard design are made, the three adolescents will be involved in a 2-week trial run, during which the predictive ability of the algorithm will be validated by the WASABI clinician, who will verify via 1:1 remote videocalls the actual presence of clinically-significant social anxiety whenever she receives an alert. Additionally, the 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 content. At the end of this test run, each stakeholder will be asked to rate enjoyment, ease of use, product quality, and perceived usefulness. Finally, we will submit these data from the trial run to our consultant to confirm that WASABI is suitable for evaluation in the feasibility trial.
In Specific Aim 2, to evaluate the acceptability and preliminary efficacy of WASABI, we will conduct a pilot augmentation trial with 32 adolescents with SA who will be randomized to dCBGT+WASABI vs dCBGT only. At 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 intervention. At the completion of Phase II, we will be able to complete the FDA regulatory pathway and have the opportunity to improve the lives of people suffering from this condition.
The goal of the current project is to elaborate upon, reconstruct and advance to pivotal trial readiness WASABI (Wiring Adolescents With Social Anxiety via Behavioral Interventions)?a clinician-assisted, adjunct to treatment, mobile application designed to augment the efficacy of psychological evidence-based treatments. By processing Ecological Momentary Assessments data collected from mobile devices, the WASABI closed-loop algorithm detects exacerbation of social anxiety, and cues 1:1 and group-based Instant Messaging with peers and providers. In this Phase I trial, we will test WASABI as an adjunct to digital Cognitive Behavioral Group Therapy in adolescents with Social Anxiety, with the goal of promoting the generalization of trained cognitive skills in the natural environment, thus improving anxiety and social functioning.
