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/Design: 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 ofeither 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 30hours 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. Discussion: 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. Trial Registration: ClinicalTrials.gov NCT02246426.
Bibliographical noteFunding Information:
The FDA has indicated through the MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) guidelines that it requires two co-primary endpoints for trials of cognitive enhancement in schizophrenia, a cognitive endpoint and a functional endpoint. We will follow these recommendations and include two co-primary outcome measures, a social cognitive outcome measure and a functional capacity measure. Our selections also adhere to the NIH toolbox recommendations regarding assessments, as this trial is sponsored by the National Institute of Mental Health (NIMH).
This project is funded by a Phase II SBIR Grant (R44MH091793) from the National Institute of Mental Health.
© 2015 Rose et al.
- Clinical trial
- Computer-based cognitive training
- Social cognition