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Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 2 (CNTRACS 2)

2026年11月5日更新者：Deanna Barch、Washington University School of Medicine

Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium

In Study 2, investigators will recruit individuals with schizophrenia (SZ) and or schizoaffective disorder (SZA) and healthy controls (HC) using optimized behavioral tasks to replicate the behavioral findings from Study 1 and to assess additional psychometric properties such as test re-test reliability and practice effects.

Investigators will obtain data on: A) clinical symptoms, with detailed assessment of hallucinations and delusions; B) community functioning; and C) functional capacity, allowing us to examine clinical validity. To generate a sample with sufficient variation in hallucinations and delusions, investigators will recruit the following groups that balance feasibility with clinical relevance: A) healthy controls [HC, N=125]; B) schizophrenia and schizoaffective disorder [SZ/SZA, N=200]). Investigators anticipate a ~20% screen fail/drop-out rate based upon prior studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC.

Investigators will administer tasks optimized in Aim 1 without electroencephalogram (EEG), to this new sample of individuals with SZ/SZA and HC.

All participants will be retested after approximately 28 days and repeat clinical assessments. Although the investigators' goal is to shorten task length using the Study 1 analyses, they will administer longer tasks than optimal for public dissemination in Study 2 to determine the minimum number of trials required for acceptable reliability. Study 2 will use the same clinical and functional measures as Study 1.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Each participant will complete 3 sessions (~3 hours each) within 3 weeks at baseline. The first session includes clinical, self-report, proxy function, and community function assessments. Sessions 2-3 are for task. Each participant will complete 7 tasks across these sessions. Task order will be counterbalanced across sessions. Participants will return after 28 days and repeat these same 3 sessions.

Clinical Assessment and Self-Report: A trained assessor will diagnose participants using the Structured Clinical Interview (SCID-5) for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Text Revision 59 (TR59). Clinicians will rate hallucination and delusion symptom severity with the Chicago Hallucinations Assessment Tool (CHAT) and the Brief Psychiatric Rating Scale (BPRS). Investigators will use the Psychotic Symptom Rating Scales (PSYRATS) to evaluate the degree of preoccupation, conviction, distress, and life disruption associated with hallucinations and delusions elicited on the BPRS and CHAT. To address specificity, investigators will administer the Clinical Assessment Interview for Negative Symptoms (CAINS). For self-report, investigators will use the Beliefs about Voices Scale which assesses attributions about the origin and power of voices, and the Yale Control Over Perceptual Experiences (COPE) scale, which evaluates the extent to which people feel they can exert control over their voices. Investigators also will use the Peters Delusion Inventory to assess the extent of delusional thinking, supplemented by the Green Paranoia Scale to provide additional coverage of persecutory beliefs. To assess specificity, investigators will use the Patient Health Questionnaire (PHQ-9) to assess depression, the Generalized Anxiety Disorder Scale (GAD-7) to assess anxiety, and the Motivation and Pleasure Scale-Self-Report (MAP-SR) to assess anhedonia and motivation. Investigators will conduct a principal components analysis (PCA) on measures of the same construct (e.g., delusions) and perform primary analyses using the first principal component, followed by secondary analyses of specific measures False Discovery Rate (FDR) correction.

Community Function: Patients will complete the Specific Levels of Functioning (SLOF) scale, a validated scale of work and community function. National Institute of Mental Health (NIMH) Common Data Elements: Investigators will acquire the additional NIMH Tier 1 Common Data elements (e.g., World Health Organization Disability Assessment Schedule 2 (WHODAS 2.0) & DSM-5 Symptom Measure). Investigators will include standard general cognitive measures to assess the specificity of effects beyond general cognitive impairment. Specifically, investigators will include validated online measures from TestMyBrain (https://www.testmybrain.org/using-tmb/research.html; Digit Symbol Coding, Vocabulary, and Matrix Reasoning), as in our prior work in both clinical and healthy populations.

研究类型

介入性

注册 (估计的)

325

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Deanna Barch, Ph.D.
电话号码：314-935-8729
邮箱：dbarch@wustl.edu

研究联系人备份

姓名：Lori Ingram
电话号码：314-747-2160
邮箱：ingram@wustl.edu

学习地点

美国
- California
  - Irvine、California、美国、92868
    - University of California Irvine
    - 接触：
      
      Cameron Carter, MD
      
      电话号码：916-734-2972
      
      邮箱：cscarte1@hs.uci.edu
- Illinois
  - Chicago、Illinois、美国、60637
    - The University of Chicago
    - 接触：
      
      Molly Erickson, PhD
      
      电话号码：(773) 702-5855
      
      邮箱：merickson1@yoda.bsd.uchicago.edu
    - 接触：
      
      Nicole Ogbuagu
      
      电话号码：773-795-2633
      
      邮箱：nicoleogbuagu@uchicago.edu
- Maryland
  - Baltimore、Maryland、美国、21201
    - University of Maryland, Baltimore
    - 接触：
      
      James Gold, MD
      
      电话号码：(410) 402-7871
      
      邮箱：jgold@som.umaryland.edu
- Minnesota
  - Minneapolis、Minnesota、美国、55455
    - University of Minnesota
    - 接触：
      
      Angus Macdonald III, PhD
      
      电话号码：612-624-3813
      
      邮箱：angus@umn.edu
    - 接触：
      
      CNTRACS Study Team
      
      电话号码：651-558-1275
      
      邮箱：CNTRACS@umn.edu
- Missouri
  - St Louis、Missouri、美国、63110
    - Washington University
    - 接触：
      
      Deanna Barch, Ph.D.
      
      电话号码：314-935-8729
      
      邮箱：dbarch@wustl.edu
    - 接触：
      
      Lori Ingram
      
      电话号码：314-747-2160
      
      邮箱：ingram@wustl.edu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 59年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

General Inclusion

age 18 to 59 ;
no substance disorder in past six months (confirmed with urine drug screens and breathalyzers);
no clinically significant head injury or neurological disease;
WechslerTest of Adult Reading (WTAR) score =16+.

Group Specific Criteria: Schizophrenia/SchizoaffectiveDisorder (SZ/SZA):

Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis ofschizophrenia or schizoaffective;
no medication changes in prior month or anticipated in the next month or not taking medications;
outpatient or partial hospital if unmedicated
Healthy Controls (HC):
no Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) - Psychosis or BipolarDisorder;
no family history of psychosis or bipolar

Exclusion Criteria:

Healthy Controls (HC):

Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)Psychosis or Bipolar Disorder diagnosis
Family history of psychosis, bipolar, or Schizophrenia/Schizoaffective Disorder (SZ/SZA)

additional exclusion criteria for the unmedicated individuals are:

not in acute exacerbation requiring immediate hospitalization or treatment;
self-reported medication non-compliance for at least the four previous weeks
never having started medications

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：基础科学
分配：不适用
介入模型：单组作业
屏蔽：无（打开标签）

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Sine Wave Speech Task Performance 大体时间：1 hour	Percentage of trials coded as speech or not vs Dprime	1 hour
Volatility Task Performance 大体时间：1 hour	Percent correct bag captures during periods of stability vs. instability - patients worse in both, but particularly impaired in instability vs. Environmental volatility belief parameter	1 hour
Minnesota Trust Game Performance 大体时间：1 hour	Percent of trusting choices depending on decision-agent and temptation vs. spite-guilt beliefs estimate	1 hour
Dynamic Trust Game Performance 大体时间：1 hour	Trust indexed by mean investment versus learning rates	1 hour
Motion Perception Task Performance 大体时间：1 hour	With 15 degrees of initial or changed direction vs. the probability of failing to update	1 hour
Kamin Blocking Task Performance 大体时间：1 hour	Number of times participant predict allergy following blocked cue vs. prediction errors and learning rates	1 hour
Choice Probabilistic Reversal Performance Task 大体时间：1 hour	Win-switch rate (higher in patients, particularly paranoid patients) vs. (prior on volatility belief updating in response to volatility	1 hour

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Washington University School of Medicine

合作者

National Institute of Mental Health (NIMH)

University of Chicago

University of Minnesota

University of California, Irvine

University of Maryland, Baltimore County

调查人员

首席研究员：Deanna Barch, PhD、Washington University School of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2028年4月1日

初级完成 (估计的)

2031年6月30日

研究完成 (估计的)

2031年6月30日

研究注册日期

首次提交

2026年10月8日

首先提交符合 QC 标准的

2026年10月8日

首次发布 (实际的)

2026年10月15日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年10月1日

Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 2 (CNTRACS 2)