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

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

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 NCT02246426 Registered 16 September 2014.

Figures

Fig. 1
Fig. 1
Study Outline. Following screening and baseline visits, participants are randomized into the experimental intervention (SocialVille) or the active control intervention (AC), in which they complete 40 sessions of training, with assessment visits conducted after 20 sessions and after training completion
Fig. 2
Fig. 2
Examples of SocialVille Training Exercises. a. The daily schedule consists of 7 exercises of 6 minutes each, for a total of 42 minutes. b. Match that Feeling exercise example. In this exercise, participants are required to match the emotion depicted by the person in the target image to the emotion of a different person from a group of faces. C. Face Facts exercise example. In this exercise, participants must remember the given facts associated with a specific person
Fig. 3
Fig. 3
Examples of Active Control (AC) Program Training Exercises. a. This daily schedule for the AC program is the same as the SocialVille program, with 7 exercises presented per day for 6 minutes each. b. Some exercises include Tri Peaks Solitaire (3-deck solitaire), War Ship (Battleship), and Bricks Breaking Hex (remove tiles of the same color)

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Source: PubMed

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