Cognitive Neurocomputational Task Reliability & Clinical Applications Consortium (CNTRACS): Study 1 (CNTRACS)

September 28, 2026 updated by: Deanna Barch, Washington University School of Medicine

Cognitive Neurocomputational Task Reliability & Clinical Applications Consortium

In Study 1, investigators will test the ability of each of the seven paradigms to differentiate between schizophrenia (SZ)/schizoaffective disorder (SZA) and matched healthy control subjects (HC) and to predict individual differences in clinical measures of hallucinations and delusions (as well as measures of function). Investigators will also directly compare the tasks in terms of predictive ability and psychometric properties and determine whether the tasks share variance or explain unique variance. This will include determining whether hallucinations and delusions are best explained by separate underlying processes or by a single process. Investigators will also test whether the model-based parameters from these studies are more precise and sensitive than standard behavioral methods for assessing deficits across psychotic disorders and for predicting hallucinations and delusions (Aim 1). Investigators will also validate key model-based parameters against well-characterized neurophysiological measures using electroencephalogram (EEG) (Aim 4). The data from Study 1 will also be used to optimize (e.g., length, floor, and ceiling effects) tasks for Study 2. 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) [HC, N=125]; B) schizophrenia and schizoaffective disorder [SZ/SZA, N=200]). For Study 1, investigators will ensure that 40 patients are unmedicated. Investigators anticipate a ~20% screen fail/drop-out rate based on our prior Cognitive Neuroscience Test Reliability and Clinical Applications for Schizophrenia Consortium (CNTRACS) studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC. All sites have experience recruiting patients in each of these groups as indicated by our past successful studies, and the fact that investigators have been able to recruit patients with significant hallucinations and delusions in all groups. Investigators will also validate key model-based parameters against well-characterized neurophysiological measures using electroencephalogram (EEG) (Aim 4). The data from Study 1 will also be used to optimize (e.g., length, floor, and ceiling effects) tasks for Study 2. 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) [HC, N=125]; B) schizophrenia and schizoaffective disorder [SZ/SZA, N=200]). For Study 1, investigators will ensure that 40 patients are unmedicated. Investigators anticipate a ~20% screen fail/drop-out rate based on our prior Cognitive Neuroscience Test Reliability and Clinical Applications for Schizophrenia Consortium (CNTRACS) studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC. All sites have experience recruiting patients in each of these groups as indicated by our past successful studies, and the fact that investigators have been able to recruit patients with significant hallucinations and delusions in all groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Each participant will complete 4 sessions (~3 hours each) within 3 weeks, as in our prior studies. The first session includes clinical, self-report, proxy function, and community function assessments. Sessions 2-4 are for task and electroencephalogram (EEG) measurements. Each participant will complete 7 tasks across these sessions, while EEG is recorded. Task order will be counterbalanced across 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). General Cognitive Ability. 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. Electroencephalogram (EEG) Procedures: During the above tasks, 64-channel EEG will be recorded from Direct Current (DC)-130 Hertz (Hz) using a 500 Hz sampling rate. Offline data preprocessing will be conducted using Matlab toolboxes EEGLAB and ERPLAB, including segmenting, baseline correction, Independent Component Analysis (ICA)-based artifact correction, artifact rejection, and filtering.

Study Type

Interventional

Enrollment (Estimated)

325

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92868
        • Recruiting
        • University of California, Irvine
        • Contact:
    • Illinois
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland, Baltimore
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
          • Angus Macdonald III, Ph.D.
          • Phone Number: 612-624-3813
          • Email: angus@umn.edu
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Recruiting
        • Washington University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

General Inclusion

  1. age 18 to 59
  2. no substance disorder in past six months (confirmed with urine drug screens and breathalyzers);
  3. no clinically significant head injury or neurological disease. 4. Wechsler Test of Adult Reading (WTAR) score =16+.

Group Specific Criteria: Schizophrenia/Schizoaffective Disorder (SZ):

  1. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective;
  2. no medication changes in prior month or anticipated in the next month or not taking medications
  3. outpatient or partial hospital if unmedicated

Healthy Controls (HC):

  1. no Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Psychosis or Bipolar Disorder;
  2. no family history of psychosis or bipolar

Exclusion Criteria:

Healthy Controls (HC):

  1. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Psychosis or Bipolar Disorder diagnosis
  2. Family history of psychosis or bipolar

Schizophrenia/Schizoaffective Disorder (SZ/SZA): additional exclusion criteria for the unmedicated individuals are:

  1. not in acute exacerbation requiring immediate hospitalization or treatment
  2. self-reported medication non-compliance for at least the four previous weeks 3)never having started medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motion Perception Task Performance
Time Frame: 1 hour

With 15 degrees of initial or changed direction vs. the probability of failing to update.
1 hour
Sine Wave Speech Task Performance
Time Frame: 1 hour

Percentage of trials coded as speech or not vs Dprime
1 hour
Volatility Task Performance
Time Frame: 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
Choice Probabilistic Reversal Performance Task
Time Frame: 1 hour

in-switch rate - higher in patients, particularly paranoid patients vs. prior on volatility belief updating in response to volatility
1 hour
Kamin Blocking Task Performance
Time Frame: 1 hour

number of times they predict allergy following blocked cue vs. prediction errors and learning rates
1 hour
Minnesota Trust Game Performance
Time Frame: 1 hour

Percent of trusting choices depending on decision-agent and temptation vs. spite-guilt beliefs estimate
1 hour
Dynamic Trust Game Performance
Time Frame: 1 hour

Trust indexed by mean investment versus learning rates
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute of Mental Health (NIMH)
University of Chicago
University of Minnesota
University of California, Irvine
University of Maryland, Baltimore County

Investigators

  • Principal Investigator: Deanna Barch, Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

June 30, 2031

Study Registration Dates

First Submitted

September 11, 2026

First Submitted That Met QC Criteria

September 28, 2026

First Posted (Actual)

October 2, 2026

Study Record Updates

Last Update Posted (Actual)

October 2, 2026

Last Update Submitted That Met QC Criteria

September 28, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201904012: Study 1
  • 2R01MH084840 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Our plan is to share de-identified participant data through the National Data Archive (NDA) as required by the National Institute of Mental Health (NIMH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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