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NCT Number: NCT07834203

State Representation in Early Psychosis 2

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.

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Key information

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota Ambulatory Research Center, Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Combined TOPX and TBT State Representation Parameter Score

    Time frame: 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

  2. P300 Amplitude During AX-CPT Task

    Time frame: 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

  3. Reward Positivity Amplitude During Translational Bandit Task

    Time frame: 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

  4. Resting-State EEG Phase Synchrony

    Time frame: 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

  5. Resting-State EEG Spectral Power Density Slope

    Time frame: 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

  6. Prefrontal and Parietal Theta Power

    Time frame: 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

Secondary outcomes

  1. Minnesota Symptoms Severity Questionnaire Score

    Time frame: 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

  2. Scale for the Assessment of Negative Symptoms Score

    Time frame: 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

  3. Scale for the Assessment of Positive Symptoms Score

    Time frame: 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

  4. Brief Psychiatric Rating Scale Score

    Time frame: 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

  5. Schizotypal Personality Questionnaire-Brief Revised Score

    Time frame: 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

  6. Intersectional Discrimination Index Score

    Time frame: 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

  7. Motivation and Pleasure Scale-Self Report Score

    Time frame: 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

  8. World Health Organization Disability Assessment Schedule Score

    Time frame: 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

  9. Global Functioning Social Scale Score

    Time frame: 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

  10. Test My Brain Matrix Reasoning Score

    Time frame: 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

  11. Test My Brain Digit Symbol Matching Score

    Time frame: 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

  12. Test My Brain Verbal Paired Associates Memory Score

    Time frame: 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

  13. Test My Brain Multiracial Emotion Recognition Score

    Time frame: 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

  14. Wechsler Test of Adult Reading Score

    Time frame: Baseline study assessment, up to 8 weeks

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

  15. Global Functioning Role Scale Score

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Owens

CONTACT

[email protected]

(612) 741-2826

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: STEP2

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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