TY - JOUR
T1 - Randomized controlled trial of computer-based treatment of social cognition in schizophrenia
T2 - The TRuSST trial protocol
AU - Rose, Annika
AU - Vinogradov, Sophia
AU - Fisher, Melissa
AU - Green, Michael F.
AU - Ventura, Joseph
AU - Hooker, Christine
AU - Merzenich, Michael
AU - Nahum, Mor
N1 - Publisher Copyright:
© 2015 Rose et al.
PY - 2015/7/3
Y1 - 2015/7/3
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Computer-based cognitive training
KW - Rehabilitation
KW - Schizophrenia
KW - Social cognition
UR - http://www.scopus.com/inward/record.url?scp=84934755996&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84934755996&partnerID=8YFLogxK
U2 - 10.1186/s12888-015-0510-1
DO - 10.1186/s12888-015-0510-1
M3 - Article
C2 - 26138715
AN - SCOPUS:84934755996
SN - 1471-244X
VL - 15
JO - BMC Psychiatry
JF - BMC Psychiatry
IS - 1
M1 - 142
ER -