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Treatment of Social Cognition in Schizophrenia Trial (TRuSST)

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ClinicalTrials.gov Identifier: NCT02246426
Recruitment Status : Recruiting
First Posted : September 22, 2014
Last Update Posted : January 26, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program targeting social cognitive abilities versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.

Condition or disease Intervention/treatment
Schizophrenia Other: Computerized plasticity-based adaptive cognitive training Other: Commercially available computerized training

Detailed Description:

The primary objective of this study is to evaluate the efficacy of SocialVille, an online training program we have recently developed (with support of a Phase I SBIR award) to treat the social cognition deficits evident in schizophrenia (DSM-IV ICD-9 Code 295.90).

SocialVille is a computerized, browser-playable program suite, designed to target information processing in the core social cognition domains of deficit in schizophrenia. It can be used from any internet-connected computer; through a dedicated clinician portal, the treating clinician can register users to treatment, continuously track and monitor their performance, and coach users throughout training. The specific aims of the study are:

  1. Specific Aim 1: Evaluate the efficacy of SocialVille as a social cognition treatment in individuals with schizophrenia. We will conduct a large-scale, multi-site, double-blind, randomized controlled clinical trial of the SocialVille medical device vs. an active computer games control, which approximates challenge, computer time and interaction with experimenter. This large trial will be conducted at four sites: University of Minnesota Medical School (site PI: Dr. Sophia Vinogradov), the Greater Los Angeles VA (Dr. Michael Green), Rush University (Dr. Christine Hooker), and University of California, Los Angeles (Drs. Joseph Ventura and Keith Nuechterlein). Study participants will complete 30 hours of training from home. At baseline, mid-way through training and immediately following training, we will employ a structured assessment battery with a co-primary SC performance measure and a co-primary functional performance measure, as well as secondary measures of SC, functional capacity, functional outcome, motivation, and quality of life.
  2. Specific Aim 2: Identify specific populations of treatment responders and non-responders. We will examine predictors of SC gain based on baseline participant demographic, symptom level, computer use, SC, and functional measures, as well as on learning rate and plateau performance measures derived over the course of SocialVille use to determine if it is possible to identify specific populations that respond very well to SocialVille use, or those who are unlikely to respond to SocialVille use.
  3. Specific Aim 3: Evaluate the effects of training on the relatively distinct low vs. high-level social cognition constructs. We will separately examine the effects of training on the independent SC factors of low level social cue detection and high-level inferential process, correlated with clinical symptoms and functional outcome, respectively.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TRuSST: Treatment of Social Cognition in Schizophrenia Trial
Study Start Date : March 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Experimental Treatment
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 40 treatment sessions, 3-5 times weekly, 45-60 minutes per session.
Other: Computerized plasticity-based adaptive cognitive training
Computerized plasticity-based adaptive cognitive training for a total maximum of 40 treatment sessions, 3-5 times weekly, 40-60 minutes per session.
Other Name: SocialVille
Active Comparator: Active Comparator
Commercially available computerized training requiring a total maximum of 40 treatment sessions, 3-5 times weekly, 45-60 minutes per session.
Other: Commercially available computerized training
Commercially available computerized training for a total maximum of 40 treatment sessions, 3-5 times weekly, 40-60 minutes per session.

Outcome Measures

Primary Outcome Measures :
  1. Social Cognitive Outcome Measure (Co-Primary Composite Measure) [ Time Frame: 4 months ]
    The a priori co-primary social cognitive outcome measure will be a composite score comprised of standardized, validated set of assessments that tap into low-level and high-level SC abilities. A composite score will be derived from all six assessments to provide a SC co-primary measure which encompasses several SC abilities. All assessments have been validated and used in outcome studies.

  2. Functional Capacity Outcome Measure (Co-Primary Composite Measure) [ Time Frame: 4 months ]
    The a priori co-primary functional measure will be the functional capacity measure of The UCSD Performance-based Skills Assessment (UPSA). We have chosen the UPSA since it is a well-validated measure frequently used in cognitive and SC training studies; In addition, it measures functional capacity, which is expected to be affected by SC change. The UPSA is designed to assess skills in five areas (Household Chores, Communication, Finance, Transportation, and Planning Recreational Activities) that reflect general abilities that are important components of independent living. Test-retest reliability ranged from .63-.80 over follow-up periods up to 36 months in patients with schizophrenia. Among patients, the UPSA performance correlated significantly with severity of negative symptoms and of cognitive impairment but not with that of positive or depressive symptoms.

Secondary Outcome Measures :
  1. Clinical Status and Symptom Severity (Composite) [ Time Frame: 4 months ]
  2. Functioning (Composite) [ Time Frame: 4 months ]
  3. Motivation (Composite) [ Time Frame: 4 months ]
  4. Quality of Life [ Time Frame: 4 months ]
  5. Additional Social Cognition Measures (Composite) [ Time Frame: 4 months ]
  6. SocialVille Exercise-based Assessments (Composite) [ Time Frame: 4 months ]

    This group of assessments serves as a positive control for task learning. We anticipate improvements in the treatment group on these assessments because they have directly practiced these tasks, as well as tasks within related cognitive domains. The data are relevant because individuals failing to make progress on exercise-based assessments may represent a subpopulation not treatable with this program, and individuals making strong progress may represent a subpopulation particularly amenable to treatment with this program.

    The 19 computerized assessments in this group are closely modeled on exercises in the 'cold' cognitive domains, and include all the SC domains covered by the SocialVille training. Specifically, we measure the amount of improvement on any one of the SocialVille exercises to quantify train-to-the-task learning.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects must be between 18 and 65 years old, inclusive, at the time of study screening
  2. Subjects must have a diagnosis of schizophrenia as defined by an interview.
  3. Subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
  4. Subjects must have been clinically stable (non-acute) for 8 weeks prior to consent; in the judgment of the Site Principal Investigator.
  5. Subjects must have been maintained on a stable treatment of antipsychotics and/or other concomitant psychotropic treatment for at least 6 weeks prior to consent.
  6. Subjects must have learned English before the age of 12 to ensure valid neuropsychological results.
  7. Subjects must have the visual, auditory, and motor capacity to use the computerized intervention in the judgment of the consenting study staff person.
  8. Subjects must have no more than a moderately severe rating on hallucinations and unusual thought content.

Exclusion Criteria:

  1. Subjects should not have had a psychiatric hospitalization in the 8 weeks prior to consent.
  2. Subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled or discontinued based upon the discretion of the site staff evaluator.
  3. Subjects should not have a history of mental retardation or pervasive developmental disorder; or other neurological disorder (e.g., Traumatic Brain Injury, epilepsy, Parkinson's Disease.)
  4. Subjects should not have been treated within 3 years of the date of consent with a computer-based cognitive training program manufactured by Posit Science.
  5. Subjects should not be participating in a concurrent clinical trial that, in the judgment of the Site Principal Investigator, could affect the outcome of this one.
  6. Subjects must not show suicidal ideation or behaviors.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246426

Contact: Dana Frostig dana.frostig@positscience.com
Contact: Sarah-Jane Kim 415-539-3130 sarah-jane.kim@positscience.com

United States, California
Greater Los Angeles VA Recruiting
Los Angeles, California, United States, 90073
Contact: Christen Chapman    310-478-3711 ext 41527    cchapman@mednet.ucla.edu   
UCLA Recruiting
Los Angeles, California, United States, 90073
Contact: Katie Rosenberry    310-206-5190    krosenberry@mednet.ucla.edu   
United States, Illinois
Rush University Recruiting
Chicago, Illinois, United States, 60612
Contact: Abhishek Saxena    312-942-4687    abhishek_saxena@rush.edu   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Shasteana Rancher    612-626-7886    trusst@umn.edu   
Sponsors and Collaborators
Posit Science Corporation
National Institute of Mental Health (NIMH)
University of Minnesota - Clinical and Translational Science Institute
VA Greater Los Angeles Healthcare System
University of California, Los Angeles
Rush University
Principal Investigator: Kyu Lee, PhD Posit Science Corporation
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT02246426     History of Changes
Other Study ID Numbers: PSC-1004-14
R44MH091793 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders