Treatment of Social Cognition in Schizophrenia Trial
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Computerized plasticity-based adaptive cognitive training; Commercially available computerized training
Intervention type(s): Other; Other
Intervention description(s): Computerized plasticity-based adaptive cognitive training for a total maximum of 40 treatment sessions, 3-5 times weekly, 40-60 minutes per session.; Commercially available computerized training for a total maximum of 40 treatment sessions, 3-5 times weekly, 40-60 minutes per session.
Other intervention name(s): SocialVille
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment