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

28 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

325

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Deanna Barch, Ph.D.
  • Telefoonnummer: 314-935-8729
  • E-mail: dbarch@wustl.edu

Studie Contact Back-up

  • Naam: Clinical Coordinator
  • Telefoonnummer: 314-747-2160
  • E-mail: ingram@wustl.edu

Studie Locaties

  • Verenigde Staten
    • California
      • Irvine, California, Verenigde Staten, 92868
        • Werving
        • University of California, Irvine
        • Contact:
    • Illinois
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21201
        • Werving
        • University of Maryland, Baltimore
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, Verenigde Staten, 55455
        • Werving
        • University of Minnesota
        • Contact:
          • Angus Macdonald III, Ph.D.
          • Telefoonnummer: 612-624-3813
          • E-mail: angus@umn.edu
        • Contact:
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63108
        • Werving
        • Washington University
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 59 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Motion Perception Task Performance
Tijdsspanne: 1 hour

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

Percentage of trials coded as speech or not vs Dprime
1 hour
Volatility Task Performance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 1 hour

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

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

Trust indexed by mean investment versus learning rates
1 hour

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Washington University School of Medicine

Medewerkers

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

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

30 juni 2031

Studie voltooiing (Geschat)

30 juni 2031

Studieregistratiedata

Eerst ingediend

11 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 september 2026

Eerst geplaatst (Werkelijk)

2 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

28 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 201904012: Study 1
  • 2R01MH084840 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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