Abstract
BackgroundSchizophrenia 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/DesignWe 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.DiscussionThe 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.Trial RegistrationClinicalTrials.gov NCT02246426Registered 16 September 2014
Highlights
Schizophrenia is a severe and chronic medical condition, characterized by positive and negative symptoms, as well as pervasive social cognitive deficits
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 randomized controlled trial (RCT) design
To address the need for a scalable and effective treatment for social cognition deficits in schizophrenia, that considers these deficits from their neurological core, we have developed SocialVille, an internet-based treatment program designed to address the core social cognitive domains of deficit in individuals with schizophrenia
Summary
Despite the functional significance of social cognition to everyday function, there is currently no effective and widely-adopted treatment approach for the extremely debilitating social cognition deficits seen in schizophrenia. The current TRuSST protocol shall help determine whether SocialVille is an effective treatment method for social cognition deficits in schizophrenia, promoting social and functional benefits that could potentially improve the quality of life of afflicted individuals and their family members. The fact that SocialVille is a highly-scalable intervention, deployed to any number of individuals at minimal cost and does not require additional clinical training, strengthens the notion that a successful TRuSST trial could result in the rapid utilization of SocialVille in schizophrenia treatment, creating a new and improved standard of care for this condition. TRuSST is one of largest trials, to the best of our knowledge that were conducted in this field of social cognition in schizophrenia The fact that it is a double-blind study further strengthens the credibility of its potential outcomes, which cannot be attributed to placebo effects or interaction with study staff.
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