SchizophreniaTRuSSTNCT02246426
Treatment of Social Cognition in Schizophrenia Trial
A study testing Computerized plasticity-based adaptive cognitive training and Commercially available computerized training in people with Schizophrenia, run by Posit Science Corporation at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Computerized plasticity-based adaptive cognitive training and Commercially available computerized training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2015to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be between 18 and 65 years old, inclusive, at the time of study screening
- Subjects must have a diagnosis of schizophrenia as defined by an interview.
- 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.
- Subjects must have been clinically stable (non-acute) for 8 weeks prior to consent; in the judgment of the Site Principal Investigator.
- 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.
- Subjects must have learned English before the age of 12 to ensure valid neuropsychological results.
- Subjects must have the visual, auditory, and motor capacity to use the computerized intervention in the judgment of the consenting study staff person.
- Subjects must have no more than a moderately severe rating on hallucinations and unusual thought content.
Who cannot join
- Subjects should not have had a psychiatric hospitalization in the 8 weeks prior to consent.
- 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.
- 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.)
- 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.
- 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.
- Subjects must not show suicidal ideation or behaviors.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rush University
Chicago, Illinois, 60612
Greater Los Angeles VA
Los Angeles, California, 90073
UCLA
Los Angeles, California, 90073
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: TRuSST: Treatment of Social Cognition in Schizophrenia Trial
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.
Read the 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:
- 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.
- Conditions
- Schizophrenia
- Being tested
- Computerized plasticity-based adaptive cognitive training, Commercially available computerized training
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized plasticity-based adaptive cognitive trainingOther
Also called SocialVille
Computerized plasticity-based adaptive cognitive training for a total maximum of 40 treatment sessions, 3-5 times weekly, 40-60 minutes per session.
Commercially available computerized trainingOther
Commercially available computerized training for a total maximum of 40 treatment sessions, 3-5 times weekly, 40-60 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Computerized plasticity-based adaptive cognitive training requiring a total maximum of 40 treatment sessions, 3-5 times weekly, 45-60 minutes per session. Receives: Other: Computerized plasticity-based adaptive cognitive training |
| 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. Receives: Other: Commercially available computerized training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score)
The a priori co-primary social cognitive outcome measure will be a composite score comprised of the following standardized, validated set of assessments:
- Penn Emotion Recognition Test (ER40) - A test for visual emotion perception; total percent correct.
- Prosody Identification (PROID) - A test for prosody identification; total percent correct.
- Penn Facial Memory Test (PFMT) -Immediate recall. A test for immediate recall of faces; total percent correct.
- Penn Facial Memory Test (PFMT) - Delayed recall. A test for delayed recall of faces; total percent correct.
- Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) - managing emotions subscale (D); correct responses.
- The Empathic Accuracy (EA) scale; average correlation.
Measured: At 6 weeks and At 12 weeks
Change in Performance on the UCSD Performance-based Skills Assessment (Co-Primary Composite Measure)
The a priori co-primary functional measure will be the functional capacity measure of The UCSD Performance-based Skills Assessment (UPSA) - total correct. Higher scores indicate better performance. 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.
Measured: At 6 weeks and At 12 weeks
Secondary outcomes (13)
Symptoms utilizing the Positive and Negative Syndrome Scale
Between-group magnitude of change in symptomatology utilizing the Positive and Negative Syndrome Scale (PANSS) - total score, negative symptoms, positive symptoms. Higher scores are indicative of greater symptomatology. The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Negative subscale consists of 7 items which assesses the negative symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity.
Measured: At 6 weeks and At 12 weeks
Psychosocial Functioning utilizing the Global Functioning Scale
Between-group magnitude of change in psychosocial functioning utilizing the Global Functioning Scale (GFS) - role and social subscales. Lower scores indicate greater impairment in functional performance. The Global Functioning Scale (GFS) is a clinician-administered questionnaire which is used to assess general psychosocial functioning. It is a 10-point rating scale (1-10), where lower score indicates greater impairment.
Measured: At 6 weeks and At 12 weeks
Social Functioning utilizing the Social Functioning Scale
Between-group magnitude of change in social functioning utilizing the Social Functioning Scale (SFS). The Social Functioning Scale was constructed specifically to tap areas of social functioning that are crucial to the community maintenance of individuals with schizophrenia. The 7 domains include: social engagement/withdrawal, interpersonal behavior, pro-social activities, recreation, independence-competence, independence-performance, and employment/occupation. The raw scores for each domain are converted to scaled scores, with a mean of 100 and a standard deviation of 15. Higher scores are indicative of greater social functioning.
Measured: At 6 weeks and At 12 weeks
Independent Functioning utilizing the Specific Levels of Function
Between-group magnitude of change in independent functioning utilizing the Specific Levels of Function (SLOF) - total score, as well as interpersonal, acceptability, activities, and work skills scores. The Specific Levels of Function (SLOF) is a 43-item scale designed to assess in detail an individual's basic living skills and level of independent functioning. Total score range from 43 to 215, higher scores indicate better functioning.
Measured: At 6 weeks and At 12 weeks
Functional Capacity utilizing Virtual Reality Functional Capacity Assessment
Between-group magnitude of change in functional capacity - the Virtual Reality Functional Capacity Assessment (VRFCAT) - total completion time. The Virtual Reality Functional Capacity Assessment measures four different functional abilities: checking for the availability of items to complete a recipe, taking a bus, shopping in a store, and managing currency. The total time ranges from 0 - 60000ms.
Measured: At 6 weeks and At 12 weeks
Quality of Life utilizing the Quality of Life Scale
Between-group magnitude of change in quality of life utilizing the Abbreviated Quality of Life Scale - total score as well as subscales. The Quality of Life Scale (QLS) is a scale commonly used as a measure of functioning in schizophrenia. The Abbreviated QLS (aQLS) includes 7 items representing all four interdependent theoretical constructs of the original 21-item QLS. Behavioral anchors are presented for each item, scored on a 0 (severe impairment) to 6 (high functioning) scale. Higher scores are indicative of greater quality of life.
Measured: At 6 weeks and At 12 weeks
Motivational systems utilizing Behavioral Inhibition/Behavioral Activation Scale
Between-group magnitude of change in motivational systems utilizing the Behavioral Inhibition/Behavioral Activation Scale (BIS-BAS) - BAS drive, fun seeking, reward, and BIS scores. The Behavioral Inhibition/Behavioral Activation Scale is a 24-item self-report questionnaire designed to assess the two general motivational systems that underlie behavior and affect, i.e. sensitivity to anticipated punishment or reward. Higher scores indicate greater sensitivity to punishment or reward.
Measured: At 6 weeks and At 12 weeks
Pleasure utilizing the Temporal Experience of Pleasure Scale
Between-group magnitude of change in pleasure utilizing the Temporal Experience of Pleasure Scale (TEPS) - total scores. The Temporal Experience of Pleasure Scale is a measure specifically designed to capture the anticipatory (10 items) and consummatory (8 items) facets of pleasure. It is a 6-point Likert scale from 1 (very false for me) to 6 (very true for me). Higher scores indicate greater pleasure experience.
Measured: At 6 weeks and At 12 weeks
Social Perception utilizing The Awareness of Social Inference Test
Between-group magnitude of change in social perception utilizing The Awareness of Social Inference Test (TASIT; Part 3) - total score. The Awareness of Social Inference Test Part 3 assesses the ability to differentiate between different kinds of counterfactual comments (lies and sarcasm). Scores range from 0-65 with lower scores indicating greater impairment in social functioning.
Measured: At 6 weeks and At 12 weeks
Emotion Perception utilizing the Morphed Faces Task
Between-group magnitude of change in emotion perception utilizing the Morphed Faces Task - accuracy and reaction time. The Morphed Faces Task is a computerized emotion perception task, in which participants are presented with faces that are morphed between a neutral expression and an emotional expression (happy, disgusted, angry, or fearful).
Measured: At 6 weeks and At 12 weeks
Theory of Mind utilizing the Faux Pas Test
Between-group magnitude of change in theory of mind utilizing the Faux Pas Test - total score. This test uses 5/10 faux pas stories and 5/10 control stories from the original Faux Pas Test. After each story is read, participants will be asked five questions for: detecting a faux pas, understanding the faux pas, understanding the mental state of the faux pas recipient, understanding the mental state of the person delivering the faux pas and understanding the details but without making inferences about the mental states of the characters in the story. The Faux Pas Test is a Theory of Mind (ToM) measure, which includes 20 short stories, incidents of faux pas (someone mistakenly saying something they shouldn't have). Lower scores indicate poor performance on the task.
Measured: At 6 weeks and At 12 weeks
Source Memory utilizing Source Memory Test
Between-group magnitude of change in source memory utilizing the Source Memory Test - Hit and False Alarm Rates. The Source Memory Test is measure of memory for the source of self-generated, and experimenter-provided word items that shows strong associations to social cognition.
Measured: At 6 weeks and At 12 weeks
Hostility Bias utilizing Ambiguous Intentions Hostility Questionnaire
Between-group magnitude of change in hostility bias utilizing the Ambiguous Intentions Hostility Questionnaire (AIHQ) - total score. The Ambiguous Intentions Hostility Questionnaire is a measure of attributional style, and specifically of hostile social-cognitive biases comprised of a variety of negative situations that differ in terms of intentionality. Higher scores indicate increased tendency to see other's action as hostile.
Measured: At 6 weeks and At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startMar 2015
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of Minnesota, VA Greater Los Angeles Healthcare System, University of California, Los Angeles, Rush University
- Responsible party
- Sponsor
- Investigators
- Kyu Lee, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246426
- Sponsor's protocol ID
- PSC-1004-14
- Other IDs
- R44MH091793
- Acronym
- TRuSST
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2014
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patel SES, Haut KM, Lee H, Fisher M, Green MF, Ventura J, Vinogradov S, Nahum M, Hooker CI. Social cognition training improves recognition of individual emotions in schizophrenia disorder. Psychiatry Res. 2025 Oct;352:116711. doi: 10.1016/j.psychres.2025.116711. Epub 2025 Aug 28.
PubMed 40915156Roberts 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.
PubMed 33539561Nahum 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.
PubMed 32614046Rose 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.
PubMed 26138715
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRuSST: Treatment of Social Cognition in Schizophrenia Trial
- ClinicalTrials.gov ID
- NCT02246426
- Acronym / sponsor ID
- TRuSST / PSC-1004-14
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of Minnesota, VA Greater Los Angeles Healthcare System, University of California, Los Angeles, Rush University
- Study start
- Mar 2015
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Other: Computerized plasticity-based adaptive cognitive trainingComputerized plasticity-based adaptive cognitive training requiring a total maximum of 40 treatment sessions, 3-5 times weekly, 45-60 minutes per session. |
| Active Comparator | Active comparator | Other: Commercially available computerized trainingCommercially available computerized training requiring a total maximum of 40 treatment sessions, 3-5 times weekly, 45-60 minutes per session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be between 18 and 65 years old, inclusive, at the time of study screening
- Subjects must have a diagnosis of schizophrenia as defined by an interview.
- 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.
- Subjects must have been clinically stable (non-acute) for 8 weeks prior to consent; in the judgment of the Site Principal Investigator.
- 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.
Key exclusion criteria (6 listed)
- Subjects should not have had a psychiatric hospitalization in the 8 weeks prior to consent.
- 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.
- 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.)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized plasticity-based adaptive cognitive trainingAlso: SocialVilleComputerized plasticity-based adaptive cognitive training for a total maximum of 40 treatment sessions, 3-5 times weekly, 40-60 minutes per session. | Other | Experimental Treatment |
| Commercially available computerized trainingCommercially available computerized training for a total maximum of 40 treatment sessions, 3-5 times weekly, 40-60 minutes per session. | Other | Active Comparator |
Primary outcome
Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score)
Time frame: At 6 weeks and At 12 weeks
The a priori co-primary social cognitive outcome measure will be a composite score comprised of the following standardized, validated set of assessments: * Penn Emotion Recognition Test (ER40) - A test for visual emotion perception; total percent correct. * Prosody Identification (PROID) - A test for prosody identification; total percent correct. * Penn Facial Memory Test (PFMT) -Immediate recall. A test for immediate recall of faces; total percent correct. * Penn Facial Memory Test (PFMT) - Delayed recall. A test for delayed recall of faces; total percent correct. * Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) - managing emotions subscale (D); correct responses. * The Empathic Accuracy (EA) scale; average correlation.
Change in Performance on the UCSD Performance-based Skills Assessment (Co-Primary Composite Measure)
Time frame: At 6 weeks and At 12 weeks
The a priori co-primary functional measure will be the functional capacity measure of The UCSD Performance-based Skills Assessment (UPSA) - total correct. Higher scores indicate better performance. 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.
13 secondary outcomes
Symptoms utilizing the Positive and Negative Syndrome Scale
Time frame: At 6 weeks and At 12 weeks
Psychosocial Functioning utilizing the Global Functioning Scale
Time frame: At 6 weeks and At 12 weeks
Social Functioning utilizing the Social Functioning Scale
Time frame: At 6 weeks and At 12 weeks
Independent Functioning utilizing the Specific Levels of Function
Time frame: At 6 weeks and At 12 weeks
Functional Capacity utilizing Virtual Reality Functional Capacity Assessment
Time frame: At 6 weeks and At 12 weeks
Quality of Life utilizing the Quality of Life Scale
Time frame: At 6 weeks and At 12 weeks
Motivational systems utilizing Behavioral Inhibition/Behavioral Activation Scale
Time frame: At 6 weeks and At 12 weeks
Pleasure utilizing the Temporal Experience of Pleasure Scale
Time frame: At 6 weeks and At 12 weeks
Social Perception utilizing The Awareness of Social Inference Test
Time frame: At 6 weeks and At 12 weeks
Emotion Perception utilizing the Morphed Faces Task
Time frame: At 6 weeks and At 12 weeks
Theory of Mind utilizing the Faux Pas Test
Time frame: At 6 weeks and At 12 weeks
Source Memory utilizing Source Memory Test
Time frame: At 6 weeks and At 12 weeks
Hostility Bias utilizing Ambiguous Intentions Hostility Questionnaire
Time frame: At 6 weeks and At 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Derived from this study: PubMed 40915156Patel SES, Haut KM, Lee H, Fisher M, Green MF, Ventura J, Vinogradov S, Nahum M, Hooker CI. Social cognition training improves recognition of individual emotions in schizophrenia disorder. Psychiatry Res. 2025 Oct;352:116711. doi: 10.1016/j.psychres.2025.116711. Epub 2025 Aug 28.
- Derived from this study: PubMed 33539561Roberts 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.
- Derived from this study: PubMed 32614046Nahum 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.
- Derived from this study: PubMed 26138715Rose 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu Lee, PhD principal investigator
Posit Science Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized plasticity-based adaptive cognitive training and Commercially available computerized training in people with Schizophrenia, run by Posit Science Corporation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score) (time frame: At 6 weeks and At 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02246426, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.