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

November 5, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

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
        • University of California Irvine
        • Contact:
    • Illinois
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
        • Contact:
          • Angus Macdonald III, PhD
          • Phone Number: 612-624-3813
          • Email: angus@umn.edu
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • 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

  • 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

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
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
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
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
Kamin Blocking Task Performance
Time Frame: 1 hour

Number of times participant predict allergy following blocked cue vs. prediction errors and learning rates
1 hour
Choice Probabilistic Reversal Performance Task
Time Frame: 1 hour

Win-switch rate (higher in patients, particularly paranoid patients) vs. (prior on volatility belief updating in response to volatility
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, PhD, 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)

April 1, 2028

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

June 30, 2031

Study Registration Dates

First Submitted

October 8, 2026

First Submitted That Met QC Criteria

October 8, 2026

First Posted (Actual)

October 15, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201904012: Study 2
  • 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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