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 : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Other: Computerized plasticity-based adaptive cognitive training Other: Commercially available computerized training||Not Applicable|
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:
- 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.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||TRuSST: Treatment of Social Cognition in Schizophrenia Trial|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
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.
- 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.
- 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.
- Clinical Status and Symptom Severity (Composite) [ Time Frame: 4 months ]
- Functioning (Composite) [ Time Frame: 4 months ]
- Motivation (Composite) [ Time Frame: 4 months ]
- Quality of Life [ Time Frame: 4 months ]
- Additional Social Cognition Measures (Composite) [ Time Frame: 4 months ]
- 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.
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 Frostigfirstname.lastname@example.org|
|Contact: Sarah-Jane Kimemail@example.com|
|United States, California|
|Greater Los Angeles VA||Active, not recruiting|
|Los Angeles, California, United States, 90073|
|UCLA||Active, not recruiting|
|Los Angeles, California, United States, 90073|
|United States, Illinois|
|Rush University||Active, not recruiting|
|Chicago, Illinois, United States, 60612|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55454|
|Contact: Shasteana Rancher 612-626-7886 firstname.lastname@example.org|
|Principal Investigator:||Kyu Lee, PhD||Posit Science Corporation|