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State Representation in Early Psychosis 2 (STEP2)

15 september 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Minnesota
      • Minneapolis, Minnesota, Förenta staterna, 55455
        • Rekrytering
        • University of Minnesota Ambulatory Research Center
        • Kontakt:
        • Huvudutredare:
          • Scott Sponheim, PhD, LP
      • Minneapolis, Minnesota, Förenta staterna, 55455
        • Rekrytering
        • University of Minnesota Department of Psychology
        • Kontakt:
        • Huvudutredare:
          • Scott Sponheim, PhD, LP

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

15 år till 45 år (Barn, Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Combined TOPX and TBT State Representation Parameter Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Minnesota Symptoms Severity Questionnaire Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Scott Sponheim, PhD, LP, University of Minnesota

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 oktober 2025

Primärt slutförande (Beräknad)

30 juni 2030

Avslutad studie (Beräknad)

30 juni 2030

Studieregistreringsdatum

Först inskickad

2 september 2026

Först inskickad som uppfyllde QC-kriterierna

15 september 2026

Första postat (Faktisk)

22 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • STUDY00024589
  • CON000000112940 (Annan identifierare: National Institute of Mental Health)

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