State Representation in Early Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 277
- 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 15-45 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. Participants will complete computerized tasks that measure state representation while having their brain activity measured.
详细描述
Participants will be asked to complete two sets of appointments six months apart. During both sets of appointments, participants will be asked to complete interviews examining behaviors and symptoms of mental health conditions, self-report questionnaires, and a neurocognitive assessment. In addition, participants will complete an imaging appointment, in which they will receive simultaneous electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI) while performing two computerized tasks.
The purpose of this study is to determine how differences in information processing that support state representation in neural circuits relate to clinical heterogeneity in early psychosis. To this end, the investigators will: (a) Recruit people with early psychosis and demographically similar adults without a psychiatric illness aged 15-45 years; (b) Determine test-retest reliability of variants of the Dot Pattern Expectancy (DPX) and Bandit tasks as assessments of state representation processes; (c) Characterize behavioral performance and neurophysiology at baseline using the DPX and Bandit task variants during simultaneous EEG-fMRI along with other MRI modalities; (d) Follow patients for 6 months while they receive usual care, to delineate their clinical trajectories; (e) Repeat the behavioral and EEG-fMRI assessments after six months. The data the investigators acquire will allow us to examine the baseline relationships between clinical and experimental measures, and also to investigate how changes in clinical and experimental measures are related over a 6-month time period during a critical phase of illness.
Participants in this protocol will be invited to participate in a follow on study, NCT05664594.
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
- •English proficiency, as determined by staff observation and participant self-report
- •Estimated IQ at or above 70, as estimated by the cognitive assessments
- •Additional Inclusion Criteria for Early Psychosis Participants:
- •Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis; those aged 36-45 years old must have had 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
- •Unable or unwilling to provide informed consent
- •The participant is unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study
- •Participant is pregnant
- •Participant is illiterate
- •Cannot pass the CMRR Subject Safety Screen due to MRI contraindications
- •Presence of a major neurological disorder (psychosis participants may have an autism spectrum diagnosis)
- •Previous clinically significant head injury or prolonged unconsciousness, as determined by the PI/Co-Is
- •Meets criteria for substance or alcohol dependence within 3 months of enrollment
- •The presence of any major medical condition that, in the opinion of the PI/Co-Is, would impede participation in the study or would put the participant at additional risk by participating
- •Presence of severe alcohol or substance abuse
- •Has participated in significant formal cognitive training programs, as determined by the PI/Co-Is
- •Additional Exclusion Criteria for Early Psychosis Participants:
- •Meets criteria for clinical risk of suicidal behavior, as defined by:
- •Clinician judgement
- •A suicide attempt within 6 months of enrollment
- •Active suicidal ideation at screening or baseline, as indicated by the C-SSRS
- •Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment, as indicated by the C-SSRS
- •Additional Exclusion Criteria for Control Participants:
- •Meets DSM-5 criteria for psychotic, bipolar, or autism spectrum disorder
- •Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder
结局指标
主要结局
Change in Performance of Dot Pattern Expectancy (DPX) Task Variant
时间窗: Baseline, 6 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. Performance is assessed based on accuracy and response time.
Change in MRI Variables
时间窗: Baseline, 6 month follow up
MRI assessments will include structural MRI, Diffusion-weighted MRI, Resting State fMRI.
Change in Performance of Bandit Task Variant
时间窗: Baseline, 6 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. Performance is based on accuracy, response time, and behavior of reward seeking.
Change in Test My Brain Neurocognitive Assessment performance: Global Cognition Z Score.
时间窗: Baseline, 6 month follow up
The investigators will examine global cognition scores from the Test My Brain neurocognitive battery. Z scores range from -5 to 5, with higher score indicating increased cognitive functioning.
Change in EEG Variables
时间窗: Baseline, 6 month follow up
Analysis will examine variables including phase synchrony, slope of the spectral power density (indexing E-I balance), and prefrontal/parietal theta as a measure of perceptual noise.
次要结局
- Change in symptoms and functioning as indicated by the SANS/SAPS(Baseline, 6 month follow up)
- Change in symptoms and functioning as indicated by the BPRS(Baseline, 6 month follow up)
- Change in symptoms and functioning as indicated by the SPQ-BR(Baseline, 6 month follow up)
- Change in symptoms and functioning as indicated by the SGI(Baseline, 6 month follow up)
- Change in symptoms and functioning as indicated by the IDI(Baseline, 6 month follow up)
- Change in symptoms and functioning as indicated by the WHODAS 2.0 Brief(Baseline, 6 month follow up)
- Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale(Baseline,6 month follow up)
- Change in symptoms and functioning as indicated by the GFS/GFR(Baseline, 6 month follow up)
- Change in Test My Brain Neurocognitive Assessment performance: Digit Symbol Matching Z Score(Baseline, 6 month follow up)
- Change in Test My Brain Neurocognitive Assessment performance: Verbal Pair Associates Memory Z Score(Baseline, 6 month follow up)
- Change in Test My Brain Neurocognitive Assessment performance: Matrix Reasoning Z Score(Baseline, 6 month follow up)
- Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score(Baseline, 6 month follow up)
研究者
Sophia Vinogradov
Professor and Department Head
University of Minnesota