State Representation in Early Psychosis 2

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-45
SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 2 trial groups
Group A: Early Psychosis Participants
Group B: Healthy Control Participants

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator