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Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol
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 relationsh...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4489025/ https://www.ncbi.nlm.nih.gov/pubmed/26138715 http://dx.doi.org/10.1186/s12888-015-0510-1 |
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author | Rose, Annika Vinogradov, Sophia Fisher, Melissa Green, Michael F. Ventura, Joseph Hooker, Christine Merzenich, Michael Nahum, Mor |
author_facet | Rose, Annika Vinogradov, Sophia Fisher, Melissa Green, Michael F. Ventura, Joseph Hooker, Christine Merzenich, Michael Nahum, Mor |
author_sort | Rose, Annika |
collection | PubMed |
description | 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 |
format | Online Article Text |
id | pubmed-4489025 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-44890252015-07-03 Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol Rose, Annika Vinogradov, Sophia Fisher, Melissa Green, Michael F. Ventura, Joseph Hooker, Christine Merzenich, Michael Nahum, Mor BMC Psychiatry Study Protocol 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 BioMed Central 2015-07-03 /pmc/articles/PMC4489025/ /pubmed/26138715 http://dx.doi.org/10.1186/s12888-015-0510-1 Text en © Rose et al. 2015 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Rose, Annika Vinogradov, Sophia Fisher, Melissa Green, Michael F. Ventura, Joseph Hooker, Christine Merzenich, Michael Nahum, Mor Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol |
title | Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol |
title_full | Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol |
title_fullStr | Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol |
title_full_unstemmed | Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol |
title_short | Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol |
title_sort | randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the trusst trial protocol |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4489025/ https://www.ncbi.nlm.nih.gov/pubmed/26138715 http://dx.doi.org/10.1186/s12888-015-0510-1 |
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