Remote State Representation in Early Psychosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Change in Performance of Dot Pattern Expectancy (DPX) Task Variant
研究概览
简要总结
The purpose of this study is to examine state representation in individuals aged 18-30 who have been diagnosed with a psychotic illness, as well as young adults who do not have a psychiatric diagnosis. State Representation is our ability to process information about our surroundings. The investigators will complete some observational tests as well as a cognitive training clinical trial.
详细描述
The purpose of the current study is to investigate computationally-informed precision treatments to improve two forms of state representation dysfunction observed in psychosis: 1) Abnormal perceptual inputs that impair state estimation; or, 2) Reduced state representation stability that affects cognitive control, working memory, and behavioral outputs. We will test the effects of two forms of cognitive training: visual perception training or visual cognitive control training in individuals with early psychosis. Participants will have the option to complete all training and assessments entirely remotely. We will recruit both young adults who have been diagnosed with a psychosis spectrum illness (such as schizophrenia) as well as individuals without a history of psychosis to participate in this study.
Early psychosis can manifest low-level perceptual deficits (such as an abnormal mismatch negativity response); these perceptual abnormalities are observed in ~60% of individuals, where they are predictive of more severe disability at 12 month follow-up, consistent with multiple studies showing that perceptual input abnormalities, when present, have a widespread deleterious downstream impact. Psychotic disorders can also manifest deficits in working memory, consistent with dysfunctional state representation stability, seen in ~80% of patients. Thus, psychosis is heterogeneous in its underlying information processing pathology and clinical course, indicating a critical unmet need for precision treatment approaches.
We will address this unmet need by investigating the behavioral and neurophysiologic effects of a brief course of either visual perception training (designed to improve state estimation processes at the perceptual input level) or visual cognitive control training (designed to enhance state representation stability of visual information), in individuals with psychotic disorders such as schizophrenia, schizoaffective disorder, and bipolar disorder with psychosis. Because study visits may be conducted remotely, participants will be drawn from a national sample. Our goal is not to perform a treatment efficacy study comparing these two interventions. Rather, we seek to use predictions derived from basic and computational neuroscience to test the effects of neuroplasticity-based precision treatments targeting two distinct contributing information processing pathologies in psychosis, with the goal of improving state representation processes and cognition.
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
- Double (Participant, Investigator)
盲法说明
The investigator will not know the treatment condition until the trial is completed. Participants will not be notified of which group they are assigned. The study coordinator will be aware of assignment but will not complete any outcomes assessments--these will be self-report.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Participants:
- •Between the ages of 18-30 at the time of screening
- •Fluent in spoken and written English, in that the participant learned to speak English before the age of 12 or is able to demonstrate fluency in conversation with study staff
- •Has an outpatient status and no hospitalization for psychiatric reasons for at least 1 month prior to participant
- •Has access to a computer with internet connection
- •Has a United States address as permanent residence
- •Estimated IQ at or above 70, as estimated by the cognitive assessments
- •Early Psychosis Participants:
- •Diagnosis of one of the following conditions (confirmed via interview): schizophrenia; schizoaffective disorder; schizophreniform disorder; Psychosis not otherwise specified (NOS); major depressive disorder with psychotic features; bipolar disorder with psychotic features
- •Willing to share contact with a clinical provider
排除标准
- •All participants:
- •History of severe substance use in the past 3 months (determined by interview)
- •Unable to demonstrate capacity to consent to research, in the judgment of the study team
- •Diagnosed with a neurological disorder that would impede participation in the study or would put the participant at additional risk by participating, in the opinion of the PI/CO-Is
- •Previous clinically significant head injury or prolonged unconsciousness
- •Significant cognitive training experience in the past 6 months
- •Meets criteria for clinical risk of suicidal behavior.
- •Non-Psychosis participants:
- •Meets DSM-5 criteria for a psychotic, bipolar, or autism spectrum disorder
- •Has a family history (1st degree relative) of psychosis, bipolar, or autism spectrum disorders
研究组 & 干预措施
Visual Perception Training
Contains targeted visual perception exercises from BrainHQ's suite of cognitive exercises. This training paradigm is designed to improve state estimation processes at the perceptual input level.
干预措施: BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm (Device)
Visual Cognitive Control Training
Contains targeted visual cognitive control exercises from BrainHQ's suite of exercises. This training paradigm is designed to enhance state representation stability of visual information.
干预措施: BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm (Device)
结局指标
主要结局
Change in Performance of Dot Pattern Expectancy (DPX) Task Variant
时间窗: Baseline, Immediately after the intervention, 5 month follow up
The DPX task variant consists of a series of pattern sequences. One pattern is designated the "A" cue, and another the "X" cue, which requires one response (AX, 60-70% of trials, e.g. respond with the left button), while other sequences require a different response (AY or BX, 12-15% of trials each, or BY, 6-10% of trials, e.g. respond with the right button). Given the strong expectation that X's evokes a valid response, BX trials place demands on the fidelity (stability, memory) of the "B" cue state representation to overcome this tendency.
Change in Performance of Bandit Task Variant
时间窗: Baseline, Immediately after the intervention, 5 month follow up
This is a task variant that uses choice options (neutral images) that are rewarded probabilistically. The rewarded stimulus with the highest reward is changed over time. State learning associated with staying or switching stimuli too quickly (lose-switching) can be evaluated.
次要结局
- Change in Test My Brain Neurocognitive Assessment performance: Global Cognition Z Score.(Baseline, Immediately after the intervention, 5 month follow up)
- Change in Test My Brain Neurocognitive Assessment performance: Verbal Pair Associates Memory Z Score(Baseline, Immediately after the intervention, 5 month follow up)
- Change in Test My Brain Neurocognitive Assessment performance: Matrix Reasoning Z Score(Baseline, Immediately after the intervention, 5 month follow up)
- Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score(Baseline, Immediately after the intervention, 5 month follow up)
- Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale(Baseline, Immediately after the intervention, 5 month follow up)
- Change in symptoms and functioning as indicated by the SANS/SAPS(Baseline, Immediately after the intervention, 5 month follow up)
- Change in symptoms and functioning as indicated by the BPRS(Baseline, Immediately after the intervention, 5 month follow up)
- Change in symptoms and functioning as indicated by the GFS/GFR(Baseline, Immediately after the intervention, 5 month follow up)