The goal of the current Phase I project is to develop (to clinical trial readiness) and evaluate feasibility of a mobile ecological momentary intervention designed to improve social functioning in individuals with schizophrenia. While 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 social, community and occupational functioning, no approaches currently monitor and facilitate the generalization of acquired skills in real-world settings. Mobile technology offers many advantages over clinic-based approaches, in that it enables real-time evaluation, interaction, and support within the individual's natural environment, thus facilitating skill transfer. Additionally, it improves access, expands reach, and targets underserved vulnerable individuals who are unable to access these specialized programs. In our preliminary work, we developed and demonstrated the feasibility of a newly designed mobile psychosocial intervention called CLIMB (Creating Live Interactions to Mitigate Barriers). CLIMB integrates computerized social cognition training with optimized remote social skills training, and is delivered entirely remotely using mobile platforms. Our preliminary data suggest that CLIMB resulted in good retention, engagement, and acceptability rates, and remediated social cognitive and quality of life impairments. In this proposal, we will first implement the current intervention with innovative features, including ecological momentary assessments, weekly self-reports, interactive training and evaluation modules, and a clinician dashboard. Next, we will evaluate the acceptability and preliminary efficacy of the revised intervention with the target population. At the completion of this project we will have outcomes data sufficient to support a large scale randomized controlled trial in Phase II (medical device trial) designed to establish medical claims defining the efficacy of this intervention to enhance social functioning for schizophrenia. At the completion of Phase II, we expect to be able to complete the FDA regulatory pathway, clear the program as the first technology- based medical device intended for the enhancement of social functioning in schizophrenia, and have the opportunity to improve the lives of millions of people suffering from this condition.
The goal of this project is to further develop (to pivotal trial readiness) and evaluate a mobile ecological momentary intervention (Creating Live Interactions to Mitigate Barriers, CLIMB) designed to improve social functioning in individuals with schizophrenia. This 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. !