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State Representation in Early Psychosis 2 (STEP2)

15 septembre 2026 mis à jour par: University of Minnesota

This observational study will examine behavioral and electroencephalography measures related to state representation in individuals with early psychosis and healthy control participants.

Participants will complete clinical interviews, self-report measures, cognitive assessments, computerized behavioral tasks, and EEG assessments. The study will evaluate performance and computed parameters from the Translational Orientation Pattern Expectancy task and Translational Bandit Task, along with EEG variables related to cognitive control, reward processing, and neural synchrony.

The study aims to better understand heterogeneity in early psychosis and identify neurocognitive and neurophysiologic markers that may inform future precision psychiatry approaches.

Aperçu de l'étude

Description détaillée

State Representation in Early Psychosis 2 is an observational study of individuals with early psychosis and healthy control participants. The study is part of an NIH Silvio O. Conte Center for Translational Mental Health Research grant and is designed to examine behavioral and neural markers of state representation processes in early psychosis.

The study will enroll individuals with early psychosis and demographically similar healthy controls. Participants will complete interviews, self-report measures, behavioral tasks, cognitive assessments, and electroencephalography assessments. The study focuses on computational and EEG measures related to state estimation, state maintenance, and state learning.

Participants will complete variants of two computerized tasks: the Translational Orientation Pattern Expectancy task and the Translational Bandit Task. EEG will be collected while participants complete these tasks and during resting state. EEG variables of interest include P300, reward positivity, phase synchrony, spectral power density slope, and prefrontal/parietal theta.

Clinical and functional measures will also be collected, including measures of psychiatric symptoms, functioning, motivation, pleasure, discrimination, disability, depression, anxiety, and general cognitive ability. The study will compare early psychosis participants with healthy control participants and evaluate how behavioral, computational, EEG, cognitive, clinical, and functional measures relate to heterogeneity in early psychosis.

Type d'étude

Observationnel

Inscription (Estimé)

500

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • Minnesota
      • Minneapolis, Minnesota, États-Unis, 55455
        • Recrutement
        • University of Minnesota Ambulatory Research Center
        • Contact:
        • Chercheur principal:
          • Scott Sponheim, PhD, LP
      • Minneapolis, Minnesota, États-Unis, 55455
        • Recrutement
        • University of Minnesota Department of Psychology
        • Contact:
        • Chercheur principal:
          • Scott Sponheim, PhD, LP

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

15 ans à 45 ans (Enfant, Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The study population includes individuals with early psychosis and demographically similar healthy control participants. Early psychosis participants will have a clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis. Healthy control participants will be recruited from the community and must not meet DSM-5 criteria for psychotic or bipolar disorder or have a first-degree family history of psychotic or bipolar disorder. Participants will be 15 to 45 years old and will complete clinical interviews, self-report measures, cognitive assessments, computerized behavioral tasks, and EEG assessments.

La description

Inclusion Criteria:

All participants:

  • Aged between 15 and 45 years
  • English proficiency, as determined by staff observation and participant self-report
  • Estimated IQ at or above 70, as estimated by cognitive assessments
  • Estimated visual acuity at 20/40, as estimated by the visual acuity test

Early Psychosis participants:

  • Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis
  • Age 35 years or younger, or age 36 to 45 years with onset of psychotic symptoms within the previous 5 years
  • Achieved clinical stability, defined as outpatient status for at least one month prior to study participation

Exclusion Criteria:

All participants:

  • Unable or unwilling to provide informed consent
  • Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member
  • Illiterate
  • Previous clinically significant head injury or prolonged unconsciousness, as determined by the investigators
  • Meets criteria for severe substance or alcohol use disorder within 3 months of behavioral assessment
  • Presence of any major medical condition that, in the opinion of the investigators, would impede participation or put the participant at additional risk
  • Has participated in significant formal cognitive training programs, as determined by the investigators
  • Meets criteria for clinical risk of suicidal behavior

Early Psychosis participants:

- Presence of a major neurological disorder

Healthy Control participants:

  • Meets DSM-5 criteria for psychotic or bipolar disorder
  • Has a first-degree family history of psychotic or bipolar disorder
  • Presence of a major neurological disorder

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Early Psychosis Participants

Participants with a clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis. Participants will complete clinical interviews, self-report measures, cognitive/computerized tasks, and EEG assessments.

Healthy Control Participants

Community control participants without psychotic or bipolar disorder and without a first-degree family history of psychotic or bipolar disorder. Participants will complete clinical interviews, self-report measures, cognitive/computerized tasks, and EEG assessments.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Combined TOPX and TBT State Representation Parameter Score
Délai: Baseline study assessment, up to 8 weeks

Performance and computed parameters from the Translational Orientation Pattern Expectancy task and Translational Bandit Task will be combined to evaluate state estimation, state maintenance, and state learning processes. The Translational Orientation Pattern Expectancy task is a cognitive control task used to evaluate dysregulated expectancy through responses to expected and unexpected stimuli. The Translational Bandit Task is a reward learning task used to evaluate responses to rewards. Together, task-derived parameters will be combined into model-derived parameter scores reflecting state estimation, state maintenance, and state learning.

Unit: model-derived parameter score

Baseline study assessment, up to 8 weeks
P300 Amplitude During AX-CPT Task
Délai: Baseline study assessment, up to 8 weeks

P300 will be assessed during the AX-CPT task as a parietally maximal positive-going event-related potential component occurring approximately 300 to 600 milliseconds after stimulus presentation. Cue-locked P300 responses to A versus B cues and probe-locked P300 responses to AX versus AY probes will be used to assess attention allocation and context/state representation during proactive and reactive cognitive control.

Unit: Microvolts

Baseline study assessment, up to 8 weeks
Reward Positivity Amplitude During Translational Bandit Task
Délai: Baseline study assessment, up to 8 weeks

Reward positivity will be assessed during the Translational Bandit Task as a frontocentrally maximal event-related potential component occurring approximately 250 to 350 milliseconds after reward versus non-reward feedback. Reward positivity will be used to assess reward sensitivity and reinforcement learning.

Unit: Microvolts

Baseline study assessment, up to 8 weeks
Resting-State EEG Phase Synchrony
Délai: Baseline study assessment, up to 8 weeks

Phase synchrony will be assessed during resting-state EEG using measures of the consistency of phase relationships between electrode sites, such as phase-locking value or weighted phase-lag index. Resting-state EEG will include eyes-closed and eyes-open conditions and will be used to assess coordination of neural activity across distributed brain regions.

Unit: phase-locking value

Baseline study assessment, up to 8 weeks
Resting-State EEG Spectral Power Density Slope
Délai: Baseline study assessment, up to 8 weeks

The slope of spectral power density will be assessed during resting-state EEG as the aperiodic, 1/f-like component of the power spectrum. The slope will be estimated after separating periodic oscillatory activity from the aperiodic component and will be used to assess cortical excitation/inhibition balance and arousal state.

Unit: aperiodic exponent

Baseline study assessment, up to 8 weeks
Prefrontal and Parietal Theta Power
Délai: Baseline study assessment, up to 8 weeks

Prefrontal and parietal theta activity will be assessed using electroencephalography during computerized tasks and resting state as a neurophysiologic measure related to cognitive control and state representation.

Unit: decibels

Baseline study assessment, up to 8 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Minnesota Symptoms Severity Questionnaire Score
Délai: Baseline study assessment, up to 8 weeks

Physical and mental well-being symptoms will be assessed using the 29-item Minnesota Symptoms Severity questionnaire. Items are scored from 1, absent, to 5, occurring nearly every day. Higher scores indicate higher frequency of physical and mental health symptoms.

Unit: points

Baseline study assessment, up to 8 weeks
Scale for the Assessment of Negative Symptoms Score
Délai: Baseline study assessment, up to 8 weeks

Negative symptoms will be assessed using the Scale for the Assessment of Negative Symptoms. Items are scored from 0, absent, to 5, severe. Higher scores indicate greater negative symptom severity.

Unit: points

Baseline study assessment, up to 8 weeks
Scale for the Assessment of Positive Symptoms Score
Délai: Baseline study assessment, up to 8 weeks

Positive symptoms will be assessed using the Scale for the Assessment of Positive Symptoms. Items are scored from 0, absent, to 5, severe. Higher scores indicate greater positive symptom severity.

Unit: points

Baseline study assessment, up to 8 weeks
Brief Psychiatric Rating Scale Score
Délai: Baseline study assessment, up to 8 weeks

Psychiatric symptoms will be assessed using the Brief Psychiatric Rating Scale. The scale assesses 24 psychiatric symptom constructs, with items scored from 1, absent, to 7, extremely severe. Higher scores indicate greater psychiatric symptom severity.

Unit: Points

Baseline study assessment, up to 8 weeks
Schizotypal Personality Questionnaire-Brief Revised Score
Délai: Baseline study assessment, up to 8 weeks

Schizotypal traits will be assessed using the 32-item Schizotypal Personality Questionnaire-Brief Revised. Items are scored from 0, strongly disagree, to 4, strongly agree. Higher scores indicate greater schizotypal trait severity.

Unit: Points

Baseline study assessment, up to 8 weeks
Intersectional Discrimination Index Score
Délai: Baseline study assessment, up to 8 weeks

Experiences of discrimination will be assessed using the 31-item Intersectional Discrimination Index. The measure uses multiple item response scales to assess experiences of, and worries about, discrimination. Higher scores indicate more frequent or more intense experiences or concerns related to discrimination.

Unit: Points

Baseline study assessment, up to 8 weeks
Motivation and Pleasure Scale-Self Report Score
Délai: Baseline study assessment, up to 8 weeks

Motivation and pleasure will be assessed using the 15-item Motivation and Pleasure Scale-Self Report. Items are scored from 0 to 4. Lower scores indicate greater deficits in motivation and pleasure.

Unit: Points

Baseline study assessment, up to 8 weeks
World Health Organization Disability Assessment Schedule Score
Délai: Baseline study assessment, up to 8 weeks

Disability will be assessed using the 15-item World Health Organization Disability Assessment Schedule. Items are scored from 1, none, to 5, extreme or cannot do. Higher scores indicate greater disability.

Unit: Points

Baseline study assessment, up to 8 weeks
Global Functioning Social Scale Score
Délai: Baseline study assessment, up to 8 weeks

Social functioning will be assessed using the Global Functioning Social scale. Scores range from 1, extreme social isolation, to 10, superior social functioning. Lower scores indicate worse social functioning.

Unit: Points

Baseline study assessment, up to 8 weeks
Test My Brain Matrix Reasoning Score
Délai: Baseline study assessment, up to 8 weeks

Fluid cognitive ability and nonverbal reasoning will be assessed using the Matrix Reasoning assessment from Test My Brain.

Unit: Points

Baseline study assessment, up to 8 weeks
Test My Brain Digit Symbol Matching Score
Délai: Baseline study assessment, up to 8 weeks

Processing speed and visual short-term memory will be assessed using the Digit Symbol Matching assessment from Test My Brain.

Unit: Points

Baseline study assessment, up to 8 weeks
Test My Brain Verbal Paired Associates Memory Score
Délai: Baseline study assessment, up to 8 weeks

Verbal memory and episodic memory will be assessed using the Verbal Paired Associates Memory assessment from Test My Brain.

Unit: points

Baseline study assessment, up to 8 weeks
Test My Brain Multiracial Emotion Recognition Score
Délai: Baseline study assessment, up to 8 weeks

Face emotion perception and emotion identification will be assessed using the Multiracial Emotion Recognition assessment from Test My Brain.

Unit: Points

Baseline study assessment, up to 8 weeks
Wechsler Test of Adult Reading Score
Délai: Baseline study assessment, up to 8 weeks

Verbal intelligence will be assessed using the Wechsler Test of Adult Reading. Unit: Points

Baseline study assessment, up to 8 weeks
Global Functioning Role Scale Score
Délai: Baseline study assessment, up to 8 weeks

Role functioning will be assessed using the Global Functioning Role scale. Scores range from 1, extremely poor role functioning, to 10, superior role functioning. Lower scores indicate worse occupational or role functioning.

Unit: Points

Baseline study assessment, up to 8 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Scott Sponheim, PhD, LP, University of Minnesota

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 octobre 2025

Achèvement primaire (Estimé)

30 juin 2030

Achèvement de l'étude (Estimé)

30 juin 2030

Dates d'inscription aux études

Première soumission

2 septembre 2026

Première soumission répondant aux critères de contrôle qualité

15 septembre 2026

Première publication (Réel)

22 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • STUDY00024589
  • CON000000112940 (Autre identifiant: National Institute of Mental Health)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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