title: Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol.
abstract: BACKGROUND
  Schizophrenia is a severe and chronic medical condition, characterized by positive and negative symptoms, as well as pervasive social cognitive deficits. Despite the functional significance of the social cognition deficits affecting many aspects of daily living, such as social relationships, occupational status, and independent living, there is still no effective treatment option for these deficits, which is applied as standard of care. To address this need, we developed a novel, internet-based training program that targets social cognition deficits in schizophrenia (SocialVille). Preliminary studies demonstrate the feasibility and initial efficacy of Socialville in schizophrenia patients (Nahum et al., 2014). The purpose of the current trial (referred to as the TReatment of Social cognition in Schizophrenia Trial or TRuSST) is to compare SocialVille to an active control training condition, include a larger sample of patients, and assess both social cognitive functioning, and functional outcomes.
  
  
  METHODS
  We will employ a multi-site, longitudinal, blinded, randomized controlled trial (RCT) design with a target sample of 128 patients with schizophrenia. Patients will perform, at their home or in clinic, 40 sessions of either the SocialVille training program or an active control computer game condition. Each session will last for 40-45 minutes/day, performed 3-5 days a week, over 10-12 weeks, totaling to 30 hours of training. Patients will be assessed on a battery of social cognitive, social functioning and functional outcomes immediately before training, mid-way through training (after 20 training sessions) and at the completion of the 40 training sessions.
  
  
  CONCLUSIONS
  The strengths of this protocol are that it tests an innovative, internet-based treatment that targets fundamental social cognitive deficits in schizophrenia, employs a highly sensitive and extensive battery of functional outcome measures, and incorporates a large sample size in an RCT design.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02246426 Registered 16 September 2014.
authors.affiliation: Posit Science Corporation, 77 Geary Street, San Francisco, CA, 94108, USA. annika.rose@positscience.com.
authors.forename: Annika
authors.initials: A
authors.lastname: Rose
authors.affiliation: San Francisco Veterans Affairs Medical Center, 4150 Clement Street, San Francisco, CA, 94143, USA. sophia.vinogradov@ucsf.edu.
authors.forename: Sophia
authors.initials: S
authors.lastname: Vinogradov
authors.affiliation: San Francisco Veterans Affairs Medical Center, 4150 Clement Street, San Francisco, CA, 94143, USA. Melissa.Fisher@ucsf.edu.
authors.forename: Melissa
authors.initials: M
authors.lastname: Fisher
authors.affiliation: VA Greater Los Angeles, 11301 Wilshire Boulevard, Los Angeles, CA, 90073, USA. mgreen@ucla.edu.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Green
authors.affiliation: UCLA Aftercare Research Program, 760 Westwood Plaza, Los Angeles, CA, 90095, USA. jventura@ucla.edu.
authors.forename: Joseph
authors.initials: J
authors.lastname: Ventura
authors.affiliation: Department of Psychology, Harvard University, 1020 William James Hall 33 Kirkland St., Cambridge, MA, 02138, USA. chooker@wjh.harvard.edu.
authors.forename: Christine
authors.initials: C
authors.lastname: Hooker
authors.affiliation: Posit Science Corporation, 77 Geary Street, San Francisco, CA, 94108, USA. mike.merzenich@positscience.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Merzenich
authors.affiliation: Posit Science Corporation, 77 Geary Street, San Francisco, CA, 94108, USA. mor.nahum@positscience.com.
authors.forename: Mor
authors.initials: M
authors.lastname: Nahum
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D003072:Cognition Disorders / Q000209:etiology / Q000523:psychology; D005260:Female; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D012107:Research Design; D012559:Schizophrenia / Q000150:complications / Q000175:diagnosis; D012565:Schizophrenic Psychology; D012917:Social Adjustment; D066107:Social Skills; D013813:Therapy, Computer-Assisted / Q000379:methods*