PROJECT SUMMARY ABSTRACT
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.
