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State Representation in Early Psychosis 2 (STEP2)

15 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

500

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

    • Minnesota
      • Minneapolis, Minnesota, Stany Zjednoczone, 55455
        • Rekrutacyjny
        • University of Minnesota Ambulatory Research Center
        • Kontakt:
        • Główny śledczy:
          • Scott Sponheim, PhD, LP
      • Minneapolis, Minnesota, Stany Zjednoczone, 55455
        • Rekrutacyjny
        • University of Minnesota Department of Psychology
        • Kontakt:
        • Główny śledczy:
          • Scott Sponheim, PhD, LP

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

15 lat do 45 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: COHORT
  • Perspektywy czasowe: PROSPECTIVE

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Combined TOPX and TBT State Representation Parameter Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Minnesota Symptoms Severity Questionnaire Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Śledczy

  • Główny śledczy: Scott Sponheim, PhD, LP, University of Minnesota

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 października 2025

Zakończenie podstawowe (Szacowany)

30 czerwca 2030

Ukończenie studiów (Szacowany)

30 czerwca 2030

Daty rejestracji na studia

Pierwszy przesłany

2 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 września 2026

Pierwszy wysłany (Rzeczywisty)

22 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • STUDY00024589
  • CON000000112940 (Inny identyfikator: National Institute of Mental Health)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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