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

BMC Psychiatry

Mor Nahum¹  Michael Merzenich¹  Christine Hooker²  Joseph Ventura⁵  Michael F. Green³  Melissa Fisher⁴  Sophia Vinogradov⁴  Annika Rose¹ 

[1] Posit Science Corporation, 77 Geary Street, San Francisco 94108, CA, USA;Department of Psychology, Harvard University, 1020 William James Hall 33 Kirkland St., Cambridge 02138, MA, USA;VA Greater Los Angeles, 11301 Wilshire Boulevard, Los Angeles 90073, CA, USA;San Francisco Veterans Affairs Medical Center, 4150 Clement Street, San Francisco 94143, CA, USA;UCLA Aftercare Research Program, 760 Westwood Plaza, Los Angeles 90095, CA, USA

关键词: Clinical trial;    Computer-based cognitive training;    Social cognition;    Rehabilitation;    Schizophrenia;   

Others  :  1217926
DOI  :  10.1186/s12888-015-0510-1

 received in 2015-04-21, accepted in 2015-05-28,  发布年份 2015

【 摘 要 】

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

TR

eatment of

S

ocial cognition in

S

chizophrenia

T

rial 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

【 授权许可】

   
2015 Rose et al.

【 图 表 】

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