NCT07834203 · University of Minnesota
State Representation in Early Psychosis 2
(STEP2)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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
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
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
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
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
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Minneapolis, Minnesota
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 22, 2026 · Source of record for eligibility and locations