State Representation in Early Psychosis 2

NCT07834203 | Recruiting

• 2 other identifiers: STUDY00024589CON000000112940
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Early Psychosis; Psychosis; Schizophrenia; Bipolar Disorder With Psychosis; Schizoaffective Disorder

Keywords

STEP2; State representation; Electroencephalography; Psychosis

Outcome Measures

Primary Outcomes (6)

• 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

  Baseline study assessment, up to 8 weeks

• 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

  Baseline study assessment, up to 8 weeks

• 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

  Baseline study assessment, up to 8 weeks

• 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

  Baseline study assessment, up to 8 weeks

• 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

  Baseline study assessment, up to 8 weeks

• 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

  Baseline study assessment, up to 8 weeks

Secondary Outcomes (15)

• Minnesota Symptoms Severity Questionnaire Score

  Baseline study assessment, up to 8 weeks

• Scale for the Assessment of Negative Symptoms Score

  Baseline study assessment, up to 8 weeks

• Scale for the Assessment of Positive Symptoms Score

  Baseline study assessment, up to 8 weeks

• Brief Psychiatric Rating Scale Score

  Baseline study assessment, up to 8 weeks

• Schizotypal Personality Questionnaire-Brief Revised Score

  Baseline study assessment, up to 8 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Minnesota Ambulatory Research Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

University of Minnesota Department of Psychology

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Scott Sponheim, PhD, LP

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Owens

CONTACT

(612) 741-2826; step2study@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 22, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

US (2)