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PsychosisSTEP (P4)NCT05664594

State Representation in Early Psychosis - Project 4

A study testing Computerized Cognitive Training in people with Psychosis and Schizophrenia, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 15 to 45 yearsHealthy volunteers can take part
What is being tested?
Computerized Cognitive Training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
31 Jul 2022to 31 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • English proficiency, as determined by staff observation and participant self-report
  • Estimated IQ at or above 70, as estimated by the cognitive assessments
  • Additional Inclusion Criteria for Early Psychosis Participants:
  • Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis; participants aged 36-45 must have onset of psychosis within the past 5 years
  • Achieved clinical stability, defined as outpatient status for at least one month prior to study participation

Who cannot join

  • Unable or unwilling to provide informed consent
  • The participant is unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study
  • Participant is pregnant
  • Participant is illiterate
  • Cannot pass the CMRR Subject Safety Screen due to MRI contraindications
  • Presence of a major neurological disorder (psychosis patients may have a diagnosis of autism spectrum disorder)
Show all 20Show fewer
  • Previous clinically significant head injury or prolonged unconsciousness, as determined by the PI/Co-Is
  • Meets criteria for substance or alcohol dependence within 3 months of enrollment
  • The presence of any major medical condition that, in the opinion of the PI/Co-Is, would impede participation in the study or would put the participant at additional risk by participating
  • Presence of severe alcohol or substance abuse
  • Has participated in significant formal cognitive training programs, as determined by the PI/Co-Is
  • Additional Exclusion Criteria for Early Psychosis Participants:
  • Meets criteria for clinical risk of suicidal behavior, as defined by:
  • Clinician judgement
  • A suicide attempt within 6 months of enrollment
  • Active suicidal ideation at screening or baseline, as indicated by the C-SSRS
  • Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment, as indicated by the C-SSRS
  • Additional Exclusion Criteria for Control Participants:
  • Meets DSM-5 criteria for psychotic, bipolar, or autism spectrum disorder
  • Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Minnesota

    Minneapolis, Minnesota, 55454

Other trials in United States

About this study

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. The investigators will complete a clinical trial examining two paradigms of cognitive training. They will study the impact of the cognitive training on state representation, measured by computerized tasks, and brain activity during those tasks.

Read the detailed description

This is the second component of the State Representation in Early Psychosis study; the first component is reflected in NCT05273164. The 6-month follow up visit data from the first component will be used as the Baseline data for this secondary component.

In this portion of the study, participants will be invited to enroll in a clinical trial examining two forms of computerized cognitive training. They will be asked to complete 10 hours of training over a 3-6 week period. Upon completion of the training paradigm, they will have two additional follow up visits, a post-intervention and a 5 month follow up (which will correspond to approximately 12 months from enrollment). At both of these appointments, participants will complete the same activities completed in the first component of this project, which include interviews examining behaviors and symptoms of mental health conditions, self-report questionnaires, and a neurocognitive assessment. In addition, participants will complete 2 imaging appointments, in which they will receive simultaneous electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI) while performing two computerized tasks.

In the second component, the investigators will recruit adults with early psychosis and demographically matched individuals without a mental health diagnosis who have completed the first component of the research. Participants will be stratified on an EEG index of state estimation processes (fronto-parietal theta power at encoding) and randomly assigned to the two training paradigms. The investigators will investigate parameter changes in the fit causal discovery analyses in each group, fit to DPX and Bandit task variant behavioral data immediately after training and 5 months later, and they will assess whether parameter changes reflect restorative or compensatory modifications. Finally, the investigators will test the hypothesis that state representation processes and cognitive performance show greater improvement in subjects who received training tailored to their state estimation parameter.

Being tested
Computerized Cognitive Training
Keywords
Cognitive Training, Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), State Representation
Medical subject headings
Psychotic Disorders, Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computerized Cognitive TrainingDevice

    Participants will complete computerized cognitive training developed by Posit Science Corporation. For a description of the training paradigms please review arm descriptions.

Study groups in NCT05664594
Study groupRoleWhat they receive
Perceptual Discrimination TrainingExperimentalTraining will involve Gabor patch and other visual stimuli discrimination exercises that focus on improving signal-to-noise resolution and attentional control with minimal working memory/cognitive control effects. On each training trial, participants are required to distinguish a target stimulus among a set of distractor stimuli. The similarity between target and distractors increases in level of difficulty based on an adaptive perceptual processing staircase function. Consecutive correct responses lead to increased modulation of the distractors to be more similar to the target, while 1 incorrect response drops the user to an easier level. Difficulty is adapted to maintain an 80% correct response rate. Each session will consist of 4 exercises requiring ~45 minutes. with 40 trials for each exercise.
Receives: Device: Computerized Cognitive Training
Visual Cognitive Control TrainingExperimentalTraining will involve maintaining accurate representations of cognitive context (the "rule") in working memory during response selection. On each training trial, participants must observe stimuli, and hold the correct response context "on-line" in order to select the correct response from among the stimuli. Training is adaptive using a staircase function, such that two consecutive correct responses increases either the speed of stimuli presentation or the working memory load via an increased number of stimuli that are presented; one incorrect response reduces the cognitive load. Each session will consist of 45 exercises requiring ~45 minutes.
Receives: Device: Computerized Cognitive Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Performance of 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  2. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  3. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  4. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  5. Change in MRI Variables

    MRI assessments will include structural MRI, Diffusion-weighted MRI, Resting State fMRI.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

Secondary outcomes (12)
  1. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  2. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  3. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  4. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  5. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  6. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  7. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  8. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  9. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  10. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  11. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

  12. 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.

    Measured: Baseline, Immediately after the intervention, 5 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study start31 Jul 2022
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05664594
Sponsor's protocol ID
STUDY00009964 (P4)
Other IDs
P50MH119569
Acronym
STEP (P4)
Status last verified
Dec 2025
First submitted
15 Dec 2022
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: This data is shared with the NIMH Data Archive, Collection ID C3504, and will include demographics, imaging data, and primary and secondary outcome data.

Questions about this trial

What is this clinical trial studying?

A study testing Computerized Cognitive Training in people with Psychosis and Schizophrenia, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Performance of DPX Task Variant (time frame: Baseline, Immediately after the intervention, 5 month follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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State Representation in Early Psychosis - Project 4 | AzTrials