Creating Live Interactions to Mitigate Barriers

The goal of this study is to employ an innovative and evidence-based mobile intervention that
includes a neuroscience-informed computerized social cognition training program, a Health
Insurance Portability and Accountability Act-compliant videoconferencing tool that we will
use for psychoeducational group therapy, and peer-to-peer secure social networking for
individuals with schizophrenia, in a parallel arm, double-blind, randomized, controlled
clinical trial to assess feasibility and initial efficacy, to investigate the intervention's
effects on symptoms, social cognition, and quality of life, and to prepare for a large-scale
efficacy trial in adults with schizophrenia.

Inclusion Criteria:

- Participants must have a clinical diagnosis of Schizophrenia as defined by the
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and confirmed by the
Structured Clinical Interview for DSM-5 (SCID)

- Participant must be clinically stable (outpatient status for at least 2 months) at
time of screening

- Participants taking psychiatric medications must be on a stable medication regimen for
greater than or equal to 4 weeks prior to screening

- Participant must be a fluent English speaker

- Participant must have adequate sensorimotor capacity to perform the program, including
visual capacity adequate to read from a computer screen at a normal viewing distance,
auditory capacity adequate to understand normal speech, and motor capacity adequate to
control a computer mouse

- Participants must be able to use iOS mobile applications

Exclusion Criteria:

- Participants with unstable and/or untreated conditions that may affect cognition,
including substance abuse/dependence disorders, cardiovascular, endocrine, neurologic
disorder, epilepsy, recent hospitalization, ongoing chemotherapy or other cancer
treatment

- Participant has a history of mental retardation, pervasive developmental disorder,
head trauma, traumatic brain injury, or other neurological disorder that impairs
cognition

- Participants who have had psychiatric hospitalizations in the 8 weeks prior to
randomization

- Participants had significant medication or clinical status changes, or adjustment in
their antipsychotic treatment in the 4 weeks prior to randomization

- Participants with active suicidal ideations and/or behaviors as measured by the
Columbia-Suicide Severity Rating Scale (C-SSRS)

- Participants showing signs of intoxication due to current substance abuse (including
alcohol and/or illegal drugs) during any in person visit

- Participants with problems performing assessments or comprehending or following spoken
instructions

- Participants enrolled in a concurrent clinical trial involving an investigational
pharmaceutical, nutraceutical, medical device, or behavioral treatment that could
affect the outcome of this study

- Participant is using computer-based cognitive training programs or has used it within
a month of the consent date