NCT05664594

State Representation in Early Psychosis - Project 4

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

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. 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.

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.

Conditions

• Psychosis
• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders
• Schizoaffective Disorder

Interventions

Type	Name	Description
DEVICE	Computerized Cognitive Training	Participants will complete computerized cognitive training developed by Posit Science Corporation. For a description of the training paradigms please review arm descriptions.

Timeline

• Start date: 2022-07-31
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2022-12-23
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study