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

Rose A, Vinogradov S, Fisher M, Green MF, Ventura J, Hooker C, Merzenich M, Nahum M - BMC Psychiatry (2015)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Posit Science Corporation, 77 Geary Street, San Francisco, CA, 94108, USA. annika.rose@positscience.com.

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.

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Related in: MedlinePlus

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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Fig3: 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)

Mentions: The active control intervention is administered in exactly the same way as the treatment intervention: it is browser-playable (from any browser) and login and password-protected. We randomly select a subset of 7 games subjects play on every session, for 6 minutes each, to equate for the time spent by the treatment group participants (see Fig. 3). The number, availability, and time spent on each game is managed by the same server which manages the treatment group exercises, hence experience is matched between the two groups. We will use games that have been shown to provide face-valid cognitive stimulation and that are rated E (for everyone) by the Entertainment Software Rating Board (ESRB).Fig. 3


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

Rose A, Vinogradov S, Fisher M, Green MF, Ventura J, Hooker C, Merzenich M, Nahum M - BMC Psychiatry (2015)

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)
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4489025&req=5

Fig3: 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)
Mentions: The active control intervention is administered in exactly the same way as the treatment intervention: it is browser-playable (from any browser) and login and password-protected. We randomly select a subset of 7 games subjects play on every session, for 6 minutes each, to equate for the time spent by the treatment group participants (see Fig. 3). The number, availability, and time spent on each game is managed by the same server which manages the treatment group exercises, hence experience is matched between the two groups. We will use games that have been shown to provide face-valid cognitive stimulation and that are rated E (for everyone) by the Entertainment Software Rating Board (ESRB).Fig. 3

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Posit Science Corporation, 77 Geary Street, San Francisco, CA, 94108, USA. annika.rose@positscience.com.

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.

Show MeSH
Related in: MedlinePlus