Recruiting

Observational StudyState Representation in Early Psychosis 2

Sponsor:

University of Minnesota

Code:

NCT07834203

Conditions

Early Psychosis

Psychosis

Schizophrenia

Bipolar Disorder With Psychosis

Schizoaffective Disorder

Eligibility Criteria

Sex: All

Age: 15 - 45

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT07834203

Start date

Oct 15, 2025

Status verified date

Sep, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 15 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

Combined TOPX and TBT State Representation Parameter Score [ Time Frame: Baseline study assessment, up to 8 weeks ]
P300 Amplitude During AX-CPT Task [ Time Frame: Baseline study assessment, up to 8 weeks ]
Reward Positivity Amplitude During Translational Bandit Task [ Time Frame: Baseline study assessment, up to 8 weeks ]
Resting-State EEG Phase Synchrony [ Time Frame: Baseline study assessment, up to 8 weeks ]
Resting-State EEG Spectral Power Density Slope [ Time Frame: Baseline study assessment, up to 8 weeks ]
Prefrontal and Parietal Theta Power [ Time Frame: Baseline study assessment, up to 8 weeks ]

Central Contacts and Locations

Central contacts

Grace Owens

(612) 741-2826 step2study@umn.edu

Locations

University of Minnesota Ambulatory Research Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Grace Owens

612-741-2826 owens387@umn.edu

Principal Investigator:

Scott Sponheim, PhD, LP

University of Minnesota Department of Psychology

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Grace Owens

612-741-2826 owens387@umn.edu

Principal Investigator:

Scott Sponheim, PhD, LP

More Information

Sponsor

University of Minnesota

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

STEP2
State representation
Electroencephalography
Psychosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.