Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services
NCT06740383
Bipolar 1 Disorder, Bipolar Disorder
Hartford, Connecticut, United States
View Trial DetailsNCT Number: NCT07834203
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.
Interested in participating?
Request Info15 year–45 year
All sexes
Observational
University of Minnesota Ambulatory Research Center, Minneapolis, Minnesota, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All participants:
Early Psychosis participants:
Exclusion criteria
All participants:
Early Psychosis participants:
Healthy Control participants:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Baseline study assessment, up to 8 weeks
Verbal intelligence will be assessed using the Wechsler Test of Adult Reading. Unit: Points
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
Contact information is provided by the study sponsor or research team.
University of Minnesota
Other
Acronym: STEP2
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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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