State Representation in Early Psychosis - Project 4

Launched by UNIVERSITY OF MINNESOTA · Dec 15, 2022

Keywords

ClinConnect Summary

This clinical trial, called "State Representation in Early Psychosis - Project 4," is looking to understand how individuals aged 15 to 45, both with and without psychotic illnesses like schizophrenia, process information about their environment. The study will involve different types of cognitive training, which is a way to help improve mental skills. Researchers want to see how these training exercises affect the participants' ability to understand and react to the world around them.

To join this study, participants need to be proficient in English and have an estimated IQ of 70 or higher. Those with early psychosis must have a diagnosed condition and have been stable in their treatment for at least a month. However, people who are pregnant, unable to understand consent, or have certain medical conditions may not qualify. Participants will engage in training sessions and may undergo assessments to measure their cognitive abilities. This study aims to gather valuable information that could help improve treatment and support for individuals experiencing psychosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • 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
• Additional Exclusion Criteria for Early Psychosis Participants:
• • Has participated in significant formal cognitive training programs, as determined by the PI/Co-Is
• * 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