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RecruitingNCT07834203STEP2Updated Sep 22, 2026

State Representation in Early Psychosis 2

An observational study in Early Psychosis, Psychosis and Schizophrenia, sponsored by University of Minnesota. Recruiting at 2 sites in United States. Open to participants aged 15 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by University of Minnesota · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
15 Years to 45 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies in Psychotic Disorders by University of Minnesota — 4 open to participants now, 6 under way, 2 of them phase 3. Psychotic Disorders · University of Minnesota.

Started
2025
with 1 other
Observational
6 of 19
1 open now
Registered
19th of 19
by date

Among the 19 studies in Psychotic Disorders by University of Minnesota, this one is one of 2 that started in 2025, is one of 6 observational ones, and was the 19th registered.

Psychotic Disorders

1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.

Browse Psychotic Disorders studies →

Open to participants now

4 of the 19 studies in Psychotic Disorders by University of Minnesota are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 205 Psychotic Disorders studies recruiting now, 53 (26%) set no upper age limit and 143 (70%) stop at 75 or younger; 51 take children under 18; 41 take healthy volunteers.

This study: 15 Years to 45 Years · all sexes · healthy volunteers too.

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02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Early Psychosis
  • Psychosis
  • Schizophrenia
  • Bipolar Disorder With Psychosis
  • Schizoaffective Disorder

Keywords

  • STEP2
  • State representation
  • Electroencephalography
  • Psychosis
04

Who can participate

Ages eligible
15 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

All participants:

  • Unable or unwilling to provide
  • Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member
  • Illiterate
  • Previous 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 criteria for psychotic or bipolar disorder
  • Has a first-degree family history of psychotic or bipolar disorder
  • Presence of a major neurological disorder
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Combined TOPX and TBT State Representation Parameter Score

    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

    Time frame: Baseline study assessment, up to 8 weeks

  2. P300 Amplitude During AX-CPT Task

    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

    Time frame: Baseline study assessment, up to 8 weeks

  3. Reward Positivity Amplitude During Translational Bandit Task

    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

    Time frame: Baseline study assessment, up to 8 weeks

  4. Resting-State EEG Phase Synchrony

    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

    Time frame: Baseline study assessment, up to 8 weeks

  5. Resting-State EEG Spectral Power Density Slope

    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

    Time frame: Baseline study assessment, up to 8 weeks

  6. Prefrontal and Parietal Theta Power

    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

    Time frame: Baseline study assessment, up to 8 weeks

Secondary outcomes

  1. Minnesota Symptoms Severity Questionnaire Score

    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

    Time frame: Baseline study assessment, up to 8 weeks

  2. Scale for the Assessment of Negative Symptoms Score

    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

    Time frame: Baseline study assessment, up to 8 weeks

  3. Scale for the Assessment of Positive Symptoms Score

    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

    Time frame: Baseline study assessment, up to 8 weeks

  4. Brief Psychiatric Rating Scale Score

    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

    Time frame: Baseline study assessment, up to 8 weeks

  5. Schizotypal Personality Questionnaire-Brief Revised Score

    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

    Time frame: Baseline study assessment, up to 8 weeks

  6. Intersectional Discrimination Index Score

    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

    Time frame: Baseline study assessment, up to 8 weeks

  7. Motivation and Pleasure Scale-Self Report Score

    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

    Time frame: Baseline study assessment, up to 8 weeks

  8. World Health Organization Disability Assessment Schedule Score

    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

    Time frame: Baseline study assessment, up to 8 weeks

  9. Global Functioning Social Scale Score

    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

    Time frame: Baseline study assessment, up to 8 weeks

  10. Test My Brain Matrix Reasoning Score

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

    Time frame: Baseline study assessment, up to 8 weeks

  11. Test My Brain Digit Symbol Matching Score

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

    Time frame: Baseline study assessment, up to 8 weeks

  12. Test My Brain Verbal Paired Associates Memory Score

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

    Time frame: Baseline study assessment, up to 8 weeks

  13. Test My Brain Multiracial Emotion Recognition Score

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

    Time frame: Baseline study assessment, up to 8 weeks

  14. Wechsler Test of Adult Reading Score

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

    Time frame: Baseline study assessment, up to 8 weeks

  15. Global Functioning Role Scale Score

    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

    Time frame: Baseline study assessment, up to 8 weeks

07

Study locations

2 of 2 sites recruiting
  • University of Minnesota Ambulatory Research Center
    Minneapolis, Minnesota 55455, United States
    Recruiting
    • Grace Owens · Contactowens387@umn.edu · 612-741-2826
    • Scott Sponheim, PhD, LP · Principal investigator
  • University of Minnesota Department of Psychology
    Minneapolis, Minnesota 55455, United States
    Recruiting
    • Grace Owens · Contactowens387@umn.edu · 612-741-2826
    • Scott Sponheim, PhD, LP · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Jun 2030, 56 months after the start.

Of 74 non-industry observational studies under Psychotic Disorders, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 124. This study's planned 56 months is below that.

Counting every sponsor, half of 76 studies reached it within 64 months; a quarter within 35 and three quarters within 124.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 22, 2026
StartActual
Oct 15, 2025
Primary completionEst.
Jun 30, 2030
CompletionEst.
Jun 30, 2030
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07834203
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Oct 15, 2025
Primary completion
Jun 30, 2030 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Sep 22, 2026

Study contacts

Grace Owens
Contact
step2study@umn.edu
(612) 741-2826
Scott Sponheim, PhD, LP
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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