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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50MH119569 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to examine state representation in individuals aged 15-45 who have been diagnosed with a psychotic illness, as well as young adults who do not have a psychiatric diagnosis. State Representation is our ability to process information about our surroundings. Participants will complete computerized tasks that measure state representation while having their brain activity measured.
Participants will be asked to complete two sets of appointments six months apart. During both sets of appointments, participants will be asked to complete interviews examining behaviors and symptoms of mental health conditions, self-report questionnaires, and a neurocognitive assessment. In addition, participants will complete an imaging appointment, in which they will receive simultaneous electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI) while performing two computerized tasks.
The purpose of this study is to determine how differences in information processing that support state representation in neural circuits relate to clinical heterogeneity in early psychosis. To this end, the investigators will: (a) Recruit people with early psychosis and demographically similar adults without a psychiatric illness aged 15-45 years; (b) Determine test-retest reliability of variants of the Dot Pattern Expectancy (DPX) and Bandit tasks as assessments of state representation processes; (c) Characterize behavioral performance and neurophysiology at baseline using the DPX and Bandit task variants during simultaneous EEG-fMRI along with other MRI modalities; (d) Follow patients for 6 months while they receive usual care, to delineate their clinical trajectories; (e) Repeat the behavioral and EEG-fMRI assessments after six months. The data the investigators acquire will allow us to examine the baseline relationships between clinical and experimental measures, and also to investigate how changes in clinical and experimental measures are related over a 6-month time period during a critical phase of illness.
Participants in this protocol will be invited to participate in a follow on study, NCT05664594.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Psychosis participants | Individuals who have been diagnosed with a psychosis spectrum illness, such as schizophrenia, and are in the early stages of the disease (i.e., aged 15-35, or if 36-45, has had the onset of psychotic symptoms within the last 5 years) | ||
| Healthy Controls | Demographically matched participants who do not have a personal or immediate family history of psychosis spectrum illnesses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Performance of Dot Pattern Expectancy (DPX) Task Variant | The DPX task variant consists of a series of pattern sequences. One pattern is designated the "A" cue, and another the "X" cue, which requires one response (AX, 60-70% of trials, e.g. respond with the left button), while other sequences require a different response (AY or BX, 12-15% of trials each, or BY, 6-10% of trials, e.g. respond with the right button). Given the strong expectation that X's evokes a valid response, BX trials place demands on the fidelity (stability, memory) of the "B" cue state representation to overcome this tendency. Performance is assessed based on accuracy and response time. | Baseline, 6 month follow up |
| Change in Performance of Bandit Task Variant | This is a task variant that uses choice options (neutral images) that are rewarded probabilistically. The rewarded stimulus with the highest reward is changed over time. State learning associated with staying or switching stimuli too quickly (lose-switching) can be evaluated. Performance is based on accuracy, response time, and behavior of reward seeking. | Baseline, 6 month follow up |
| Change in Test My Brain Neurocognitive Assessment performance: Global Cognition Z Score. | The investigators will examine global cognition scores from the Test My Brain neurocognitive battery. Z scores range from -5 to 5, with higher score indicating increased cognitive functioning. | Baseline, 6 month follow up |
| Change in EEG Variables | Analysis will examine variables including phase synchrony, slope of the spectral power density (indexing E-I balance), and prefrontal/parietal theta as a measure of perceptual noise. | Baseline, 6 month follow up |
| Change in MRI Variables | MRI assessments will include structural MRI, Diffusion-weighted MRI, Resting State fMRI. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale | This 29-item measure assesses symptoms in several domains such as anxiety, depression, sleep problems, somatic symptoms, and substance use. Scores range from 0 to 116, with a higher score indicating greater symptom severity. | Baseline,6 month follow up |
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Inclusion Criteria:
Additional Inclusion Criteria for Early Psychosis Participants:
Exclusion Criteria:
Additional Exclusion Criteria for Early Psychosis Participants:
Additional Exclusion Criteria for Control Participants:
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Participants are recruited from Minnesota. Most participants are located in the Twin Cities Metro area.
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| Name | Affiliation | Role |
|---|---|---|
| Sophia Vinogradov, MD | University of Minnesota | Principal Investigator |
| Angus MacDonald III, Ph.D. | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
This data is shared with the NIMH Data Archive, Collection ID C3504, and will include demographics, imaging data, and primary and secondary outcome data.
The data will become available 12 months after the completion of this study.
Access will be provided to users who have an account with the NIMH Data Archive and who request permission through a Data Access Request.
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Baseline, 6 month follow up |
| Change in symptoms and functioning as indicated by the SANS/SAPS |
The Scale for Assessment of Negative Symptoms (SANS, 25 items) and Scale for Assessment of Positive Symptoms (SAPS, 34 items) assess negative and positive symptoms of schizophrenia in a standardized interview. Scores on the SANS ranges from 0-125, and the SANS ranges from 0-170, with higher scores indicating increased symptom severity. |
| Baseline, 6 month follow up |
| Change in symptoms and functioning as indicated by the BPRS | The Brief Psychiatric Rating Scale is a 24-item interview which assesses psychiatric symptoms. Scores on the BPRS rang from 24-168, with a higher score indicating increased symptom severity. | Baseline, 6 month follow up |
| Change in symptoms and functioning as indicated by the SPQ-BR | Schizotypal Personality Questionnaire Brief Revised, a 32-item measure to assess a broad array of schizotypal symptoms and signs. The SPQ ranges from 32-160, with a higher score indicating greater schizotypy. | Baseline, 6 month follow up |
| Change in symptoms and functioning as indicated by the SGI | The Sensory Gating Inventory Brief is a 10-item measure assesses an individual's subjective ability to modulate, filter, over-include, discriminate, attend to, and tolerate sensory stimuli. The SGI ranges from 10-60, with higher score indicating increased perceptual abnormalities. | Baseline, 6 month follow up |
| Change in symptoms and functioning as indicated by the IDI | The Intersectional Discrimination Index is a 31-item measure assesses anticipated, day to day, and major discrimination experienced by the participant. Scores range from 0-136, with higher scores indicating greater discrimination experienced by the individual. | Baseline, 6 month follow up |
| Change in symptoms and functioning as indicated by the WHODAS 2.0 Brief | The World Health Organization Disability Assessment Schedule is a 12-item self-administered scale measuring disability and functional impairment. The WHODAS ranges in score from 12-60, with a higher score indicating increased disability. | Baseline, 6 month follow up |
| Change in symptoms and functioning as indicated by the GFS/GFR | The Global Functioning Social/Global Functioning Role scales provide a rating on a scale from 1-10 for social functioning and for role functioning, with higher scores indicating increased functioning. | Baseline, 6 month follow up |
| Change in Test My Brain Neurocognitive Assessment performance: Digit Symbol Matching Z Score | This subdomain of the TMB battery assesses processing speed. Z scores range from -5 to 5, with higher score indicating increased functioning. | Baseline, 6 month follow up |
| Change in Test My Brain Neurocognitive Assessment performance: Verbal Pair Associates Memory Z Score | This subdomain of the TMB battery assesses verbal learning. Z scores range from -5 to 5, with higher score indicating increased functioning. | Baseline, 6 month follow up |
| Change in Test My Brain Neurocognitive Assessment performance: Matrix Reasoning Z Score | This subdomain of the TMB battery assesses reasoning skills and also provides an IQ estimate. Z scores range from -5 to 5, with higher score indicating increased functioning. | Baseline, 6 month follow up |
| Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score | This subdomain of the TMB battery is a social cognition test that assesses the ability to recognize emotions (happiness, sadness, anger, and fear). Z scores range from -5 to 5, with higher score indicating increased functioning. | Baseline, 6 month follow up |