State Representation in Early Psychosis 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Combined TOPX and TBT State Representation Parameter Score
研究概览
简要总结
This observational study will examine behavioral and electroencephalography measures related to state representation in individuals with early psychosis and healthy control participants.
Participants will complete clinical interviews, self-report measures, cognitive assessments, computerized behavioral tasks, and EEG assessments. The study will evaluate performance and computed parameters from the Translational Orientation Pattern Expectancy task and Translational Bandit Task, along with EEG variables related to cognitive control, reward processing, and neural synchrony.
The study aims to better understand heterogeneity in early psychosis and identify neurocognitive and neurophysiologic markers that may inform future precision psychiatry approaches.
详细描述
State Representation in Early Psychosis 2 is an observational study of individuals with early psychosis and healthy control participants. The study is part of an NIH Silvio O. Conte Center for Translational Mental Health Research grant and is designed to examine behavioral and neural markers of state representation processes in early psychosis.
The study will enroll individuals with early psychosis and demographically similar healthy controls. Participants will complete interviews, self-report measures, behavioral tasks, cognitive assessments, and electroencephalography assessments. The study focuses on computational and EEG measures related to state estimation, state maintenance, and state learning.
Participants will complete variants of two computerized tasks: the Translational Orientation Pattern Expectancy task and the Translational Bandit Task. EEG will be collected while participants complete these tasks and during resting state. EEG variables of interest include P300, reward positivity, phase synchrony, spectral power density slope, and prefrontal/parietal theta.
Clinical and functional measures will also be collected, including measures of psychiatric symptoms, functioning, motivation, pleasure, discrimination, disability, depression, anxiety, and general cognitive ability. The study will compare early psychosis participants with healthy control participants and evaluate how behavioral, computational, EEG, cognitive, clinical, and functional measures relate to heterogeneity in early psychosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants:
- •Aged between 15 and 45 years
- •English proficiency, as determined by staff observation and participant self-report
- •Estimated IQ at or above 70, as estimated by cognitive assessments
- •Estimated visual acuity at 20/40, as estimated by the visual acuity test
- •Early Psychosis participants:
- •Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis
- •Age 35 years or younger, or age 36 to 45 years with onset of psychotic symptoms within the previous 5 years
- •Achieved clinical stability, defined as outpatient status for at least one month prior to study participation
排除标准
- •All participants:
- •Unable or unwilling to provide informed consent
- •Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member
- •Illiterate
- •Previous clinically significant head injury or prolonged unconsciousness, as determined by the investigators
- •Meets criteria for severe substance or alcohol use disorder within 3 months of behavioral assessment
- •Presence of any major medical condition that, in the opinion of the investigators, would impede participation or put the participant at additional risk
- •Has participated in significant formal cognitive training programs, as determined by the investigators
- •Meets criteria for clinical risk of suicidal behavior
- •Early Psychosis participants:
- •- Presence of a major neurological disorder
- •Healthy Control participants:
- •Meets DSM-5 criteria for psychotic or bipolar disorder
- •Has a first-degree family history of psychotic or bipolar disorder
- •Presence of a major neurological disorder
研究组 & 干预措施
Early Psychosis Participants
Participants with a clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis. Participants will complete clinical interviews, self-report measures, cognitive/computerized tasks, and EEG assessments.
Healthy Control Participants
Community control participants without psychotic or bipolar disorder and without a first-degree family history of psychotic or bipolar disorder. Participants will complete clinical interviews, self-report measures, cognitive/computerized tasks, and EEG assessments.
结局指标
主要结局
Combined TOPX and TBT State Representation Parameter Score
时间窗: Baseline study assessment, up to 8 weeks
Performance and computed parameters from the Translational Orientation Pattern Expectancy task and Translational Bandit Task will be combined to evaluate state estimation, state maintenance, and state learning processes. The Translational Orientation Pattern Expectancy task is a cognitive control task used to evaluate dysregulated expectancy through responses to expected and unexpected stimuli. The Translational Bandit Task is a reward learning task used to evaluate responses to rewards. Together, task-derived parameters will be combined into model-derived parameter scores reflecting state estimation, state maintenance, and state learning. Unit: model-derived parameter score
P300 Amplitude During AX-CPT Task
时间窗: Baseline study assessment, up to 8 weeks
P300 will be assessed during the AX-CPT task as a parietally maximal positive-going event-related potential component occurring approximately 300 to 600 milliseconds after stimulus presentation. Cue-locked P300 responses to A versus B cues and probe-locked P300 responses to AX versus AY probes will be used to assess attention allocation and context/state representation during proactive and reactive cognitive control. Unit: Microvolts
Reward Positivity Amplitude During Translational Bandit Task
时间窗: Baseline study assessment, up to 8 weeks
Reward positivity will be assessed during the Translational Bandit Task as a frontocentrally maximal event-related potential component occurring approximately 250 to 350 milliseconds after reward versus non-reward feedback. Reward positivity will be used to assess reward sensitivity and reinforcement learning. Unit: Microvolts
Resting-State EEG Phase Synchrony
时间窗: Baseline study assessment, up to 8 weeks
Phase synchrony will be assessed during resting-state EEG using measures of the consistency of phase relationships between electrode sites, such as phase-locking value or weighted phase-lag index. Resting-state EEG will include eyes-closed and eyes-open conditions and will be used to assess coordination of neural activity across distributed brain regions. Unit: phase-locking value
Resting-State EEG Spectral Power Density Slope
时间窗: Baseline study assessment, up to 8 weeks
The slope of spectral power density will be assessed during resting-state EEG as the aperiodic, 1/f-like component of the power spectrum. The slope will be estimated after separating periodic oscillatory activity from the aperiodic component and will be used to assess cortical excitation/inhibition balance and arousal state. Unit: aperiodic exponent
Prefrontal and Parietal Theta Power
时间窗: Baseline study assessment, up to 8 weeks
Prefrontal and parietal theta activity will be assessed using electroencephalography during computerized tasks and resting state as a neurophysiologic measure related to cognitive control and state representation. Unit: decibels
次要结局
- Minnesota Symptoms Severity Questionnaire Score(Baseline study assessment, up to 8 weeks)
- Scale for the Assessment of Negative Symptoms Score(Baseline study assessment, up to 8 weeks)
- Scale for the Assessment of Positive Symptoms Score(Baseline study assessment, up to 8 weeks)
- Brief Psychiatric Rating Scale Score(Baseline study assessment, up to 8 weeks)
- Schizotypal Personality Questionnaire-Brief Revised Score(Baseline study assessment, up to 8 weeks)
- Intersectional Discrimination Index Score(Baseline study assessment, up to 8 weeks)
- Motivation and Pleasure Scale-Self Report Score(Baseline study assessment, up to 8 weeks)
- World Health Organization Disability Assessment Schedule Score(Baseline study assessment, up to 8 weeks)
- Global Functioning Social Scale Score(Baseline study assessment, up to 8 weeks)
- Test My Brain Matrix Reasoning Score(Baseline study assessment, up to 8 weeks)
- Test My Brain Digit Symbol Matching Score(Baseline study assessment, up to 8 weeks)
- Test My Brain Verbal Paired Associates Memory Score(Baseline study assessment, up to 8 weeks)
- Test My Brain Multiracial Emotion Recognition Score(Baseline study assessment, up to 8 weeks)
- Wechsler Test of Adult Reading Score(Baseline study assessment, up to 8 weeks)
- Global Functioning Role Scale Score(Baseline study assessment, up to 8 weeks)