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BMC Psychiatry
Published in: BMC Psychiatry 1/2015

Open Access 01-12-2015 | Study protocol

Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol

Authors: Annika Rose, Sophia Vinogradov, Melissa Fisher, Michael F. Green, Joseph Ventura, Christine Hooker, Michael Merzenich, Mor Nahum

Published in: BMC Psychiatry | Issue 1/2015

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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/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 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.

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 NCT02246426Registered 16 September 2014
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Metadata
Title
Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol
Authors
Annika Rose
Sophia Vinogradov
Melissa Fisher
Michael F. Green
Joseph Ventura
Christine Hooker
Michael Merzenich
Mor Nahum
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2015
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-015-0510-1

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