State Representation in Early Psychosis — STEP  

Schizophrenia Clinical Trial

Official title: State Representation in Early Psychosis

Status Recruiting

Clinical 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. The investigators will complete some observational tests as well as a cognitive training clinical trial.

Clinical Trial Description

In the first component of this study, 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 EEG and fMRI while performing two computerized tasks.

The purpose of this component is to determine how failures 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 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.

In the second component of this 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, including the interviews, questionnaires, neurocognitive assessment, and imaging combined with 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05273164
• Study type: Interventional
• Source: University of Minnesota
• Contact: Connor Petricek, BA
• Phone: 612-741-2826
• Email: Stepstudy@umn.edu
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Completion date: March 31, 2025