Schizophrenia Clinical Trial
Official title:
TRuSST: Treatment of Social Cognition in Schizophrenia Trial
This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program targeting social cognitive abilities versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.
The primary objective of this study is to evaluate the efficacy of SocialVille, an online
training program we have recently developed (with support of a Phase I SBIR award) to treat
the social cognition deficits evident in schizophrenia (DSM-IV ICD-9 Code 295.90).
SocialVille is a computerized, browser-playable program suite, designed to target information
processing in the core social cognition domains of deficit in schizophrenia. It can be used
from any internet-connected computer; through a dedicated clinician portal, the treating
clinician can register users to treatment, continuously track and monitor their performance,
and coach users throughout training. The specific aims of the study are:
1. Specific Aim 1: Evaluate the efficacy of SocialVille as a social cognition treatment in
individuals with schizophrenia. We will conduct a large-scale, multi-site, double-blind,
randomized controlled clinical trial of the SocialVille medical device vs. an active
computer games control, which approximates challenge, computer time and interaction with
experimenter. This large trial will be conducted at four sites: University of Minnesota
Medical School (site PI: Dr. Sophia Vinogradov), the Greater Los Angeles VA (Dr. Michael
Green), Rush University (Dr. Christine Hooker), and University of California, Los
Angeles (Drs. Joseph Ventura and Keith Nuechterlein). Study participants will complete
30 hours of training from home. At baseline, mid-way through training and immediately
following training, we will employ a structured assessment battery with a co-primary SC
performance measure and a co-primary functional performance measure, as well as
secondary measures of SC, functional capacity, functional outcome, motivation, and
quality of life.
2. Specific Aim 2: Identify specific populations of treatment responders and
non-responders. We will examine predictors of SC gain based on baseline participant
demographic, symptom level, computer use, SC, and functional measures, as well as on
learning rate and plateau performance measures derived over the course of SocialVille
use to determine if it is possible to identify specific populations that respond very
well to SocialVille use, or those who are unlikely to respond to SocialVille use.
3. Specific Aim 3: Evaluate the effects of training on the relatively distinct low vs.
high-level social cognition constructs. We will separately examine the effects of
training on the independent SC factors of low level social cue detection and high-level
inferential process, correlated with clinical symptoms and functional outcome,
respectively.
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