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

28 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

325

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Deanna Barch, Ph.D.
  • Número de teléfono: 314-935-8729
  • Correo electrónico: dbarch@wustl.edu

Copia de seguridad de contactos de estudio

  • Nombre: Clinical Coordinator
  • Número de teléfono: 314-747-2160
  • Correo electrónico: ingram@wustl.edu

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Irvine, California, Estados Unidos, 92868
        • Reclutamiento
        • University of California, Irvine
        • Contacto:
          • Cameron Carter, MD
          • Número de teléfono: 916-734-2972
          • Correo electrónico: cscarte1@hs.uci.edu
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • Reclutamiento
        • University of Maryland, Baltimore
        • Contacto:
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • Reclutamiento
        • University of Minnesota
        • Contacto:
          • Angus Macdonald III, Ph.D.
          • Número de teléfono: 612-624-3813
          • Correo electrónico: angus@umn.edu
        • Contacto:
          • Alyssa Zimmerman, BA
          • Número de teléfono: 651-558-1275
          • Correo electrónico: zimme857@umn.edu
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63108
        • Reclutamiento
        • Washington University
        • Contacto:
          • Deanna Barch, Ph.D.
          • Número de teléfono: 314-935-8729
          • Correo electrónico: dbarch@wustl.edu
        • Contacto:
          • Lori Ingram
          • Número de teléfono: 314-747-2160
          • Correo electrónico: ingram@wustl.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 59 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Motion Perception Task Performance
Periodo de tiempo: 1 hour

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

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

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

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

Trust indexed by mean investment versus learning rates
1 hour

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Washington University School of Medicine

Colaboradores

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

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

30 de junio de 2031

Finalización del estudio (Estimado)

30 de junio de 2031

Fechas de registro del estudio

Enviado por primera vez

11 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Publicado por primera vez (Actual)

2 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 201904012: Study 1
  • 2R01MH084840 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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