TRuSST: Treatment of Social Cognition in Schizophrenia Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 8
- 主要终点
- Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Computerized plasticity-based adaptive cognitive training (Other)
Active Comparator
Commercially available computerized training requiring a total maximum of 40 treatment sessions, 3-5 times weekly, 45-60 minutes per session.
干预措施: Commercially available computerized training (Other)
结局指标
主要结局
Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score)
时间窗: 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)
时间窗: 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.
次要结局
- Source Memory utilizing Source Memory Test(At 6 weeks and At 12 weeks)
- Symptoms utilizing the Positive and Negative Syndrome Scale(At 6 weeks and At 12 weeks)
- Psychosocial Functioning utilizing the Global Functioning Scale(At 6 weeks and At 12 weeks)
- Quality of Life utilizing the Quality of Life Scale(At 6 weeks and At 12 weeks)
- Motivational systems utilizing Behavioral Inhibition/Behavioral Activation Scale(At 6 weeks and At 12 weeks)
- Social Perception utilizing The Awareness of Social Inference Test(At 6 weeks and At 12 weeks)
- Independent Functioning utilizing the Specific Levels of Function(At 6 weeks and At 12 weeks)
- Pleasure utilizing the Temporal Experience of Pleasure Scale(At 6 weeks and At 12 weeks)
- Emotion Perception utilizing the Morphed Faces Task(At 6 weeks and At 12 weeks)
- Hostility Bias utilizing Ambiguous Intentions Hostility Questionnaire(At 6 weeks and At 12 weeks)
- Functional Capacity utilizing Virtual Reality Functional Capacity Assessment(At 6 weeks and At 12 weeks)
- Theory of Mind utilizing the Faux Pas Test(At 6 weeks and At 12 weeks)
- Social Functioning utilizing the Social Functioning Scale(At 6 weeks and At 12 weeks)