State Representation in Early Psychosis - Project 4
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in EEG Variables
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. The investigators will complete a clinical trial examining two paradigms of cognitive training. They will study the impact of the cognitive training on state representation, measured by computerized tasks, and brain activity during those tasks.
详细描述
This is the second component of the State Representation in Early Psychosis study; the first component is reflected in NCT05273164. The 6-month follow up visit data from the first component will be used as the Baseline data for this secondary component.
In this portion of the study, participants will be invited to enroll in a clinical trial examining two forms of computerized cognitive training. They will be asked to complete 10 hours of training over a 3-6 week period. Upon completion of the training paradigm, they will have two additional follow up visits, a post-intervention and a 5 month follow up (which will correspond to approximately 12 months from enrollment). At both of these appointments, participants will complete the same activities completed in the first component of this project, which include interviews examining behaviors and symptoms of mental health conditions, self-report questionnaires, and a neurocognitive assessment. In addition, participants will complete 2 imaging appointments, in which they will receive simultaneous electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI) while performing two computerized tasks.
In the second component, the investigators will recruit adults with early psychosis and demographically matched individuals without a mental health diagnosis who have completed the first component of the research. Participants will be stratified on an EEG index of state estimation processes (fronto-parietal theta power at encoding) and randomly assigned to the two training paradigms. The investigators will investigate parameter changes in the fit causal discovery analyses in each group, fit to DPX and Bandit task variant behavioral data immediately after training and 5 months later, and they will assess whether parameter changes reflect restorative or compensatory modifications. Finally, the investigators will test the hypothesis that state representation processes and cognitive performance show greater improvement in subjects who received training tailored to their state estimation parameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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; participants aged 36-45 must have onset of psychosis within the past 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 patients may have a diagnosis of autism spectrum disorder)
- •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 EEG Variables
时间窗: Baseline, Immediately after the intervention, 5 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.
Change in MRI Variables
时间窗: Baseline, Immediately after the intervention, 5 month follow up
MRI assessments will include structural MRI, Diffusion-weighted MRI, Resting State fMRI.
Change in Performance of 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.
Change in Test My Brain Neurocognitive Assessment performance: Global Cognition Z Score.
时间窗: Baseline, Immediately after the intervention, 5 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.
次要结局
- 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)
- 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 SPQ-BR(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 SGI(Baseline, Immediately after the intervention, 5 month follow up)
- Change in symptoms and functioning as indicated by the IDI(Baseline, Immediately after the intervention, 5 month follow up)
- Change in symptoms and functioning as indicated by the WHODAS 2.0 Brief(Baseline, Immediately after the intervention, 5 month follow up)
- Change in Test My Brain Neurocognitive Assessment performance: Digit Symbol Matching 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: Multiracial Emotion Identification 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)