Clinical trial NCT02246426: Treatment of Social Cognition in Schizophrenia Trial
Official title: TRuSST: Treatment of Social Cognition in Schizophrenia Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Minnesota
name: VA Greater Los Angeles Healthcare System
name: University of California, Los Angeles
name: Rush University
First posted: 2014-09-22
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score)
timeFrame: At 6 weeks and At 12 weeks
measure: Change in Performance on the UCSD Performance-based Skills Assessment (Co-Primary Composite Measure)
timeFrame: At 6 weeks and At 12 weeks
Secondary outcomes:
measure: Symptoms utilizing the Positive and Negative Syndrome Scale
timeFrame: At 6 weeks and At 12 weeks
measure: Psychosocial Functioning utilizing the Global Functioning Scale
timeFrame: At 6 weeks and At 12 weeks
measure: Social Functioning utilizing the Social Functioning Scale
timeFrame: At 6 weeks and At 12 weeks
measure: Independent Functioning utilizing the Specific Levels of Function
timeFrame: At 6 weeks and At 12 weeks
measure: Functional Capacity utilizing Virtual Reality Functional Capacity Assessment
timeFrame: At 6 weeks and At 12 weeks
measure: Quality of Life utilizing the Quality of Life Scale
timeFrame: At 6 weeks and At 12 weeks
measure: Motivational systems utilizing Behavioral Inhibition/Behavioral Activation Scale
timeFrame: At 6 weeks and At 12 weeks
measure: Pleasure utilizing the Temporal Experience of Pleasure Scale
timeFrame: At 6 weeks and At 12 weeks
measure: Social Perception utilizing The Awareness of Social Inference Test
timeFrame: At 6 weeks and At 12 weeks
measure: Emotion Perception utilizing the Morphed Faces Task
timeFrame: At 6 weeks and At 12 weeks
measure: Theory of Mind utilizing the Faux Pas Test
timeFrame: At 6 weeks and At 12 weeks
measure: Source Memory utilizing Source Memory Test
timeFrame: At 6 weeks and At 12 weeks
measure: Hostility Bias utilizing Ambiguous Intentions Hostility Questionnaire
timeFrame: At 6 weeks and At 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Greater Los Angeles VA
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Posit Science Corporation
name: Kyu Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
citation: Nahum M, Lee H, Fisher M, Green MF, Hooker CI, Ventura J, Jordan JT, Rose A, Kim SJ, Haut KM, Merzenich MM, Vinogradov S. Online Social Cognition Training in Schizophrenia: A Double-Blind, Randomized, Controlled Multi-Site Clinical Trial. Schizophr Bull. 2021 Jan 23;47(1):108-117. doi: 10.1093/schbul/sbaa085.
citation: Rose A, Vinogradov S, Fisher M, Green MF, Ventura J, Hooker C, Merzenich M, Nahum M. Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol. BMC Psychiatry. 2015 Jul 3;15:142. doi: 10.1186/s12888-015-0510-1.