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Recruiting
NCT05664594
State Representation in Early Psychosis - Project 4
Conditions: Psychosis, Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Schizoaffective Disorder
Sex: All
Ages: 15 Years – 45 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 200
Sponsor: University of Minnesota
Location: United States
Summary
The purpose of this study is to examine state representation in individuals aged 15-40 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.
Eligibility Criteria
Inclusion Criteria:English proficiency, as determined by staff observation and participant self-reportEstimated IQ at or above 70, as estimated by the cognitive assessmentsAdditional 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, with onset of psychotic symptoms within the previous 5 yearsAchieved clinical stability, defined as outpatient status for at least one month prior to study participation plus clinically stable doses of psychiatry medications for at least one month prior to study participationExclusion Criteria:Unable or unwilling to provide informed consentThe 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 studyParticipant is pregnantParticipant is illiterateCannot pass the CMRR Subject Safety Screen due to MRI contraindicationsPresence of a major neurological disorderPrevious clinically significant head injury or prolonged unconsciousness, as determined by the PI/Co-IsMeets criteria for substance or alcohol dependence within 3 months of enrollmentThe 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 participatingAdditional Exclusion Criteria for Early Psychosis Participants:Has participated in significant formal cognitive training programs, as determined by the PI/Co-IsMeets criteria for clinical risk of suicidal behavior, as defined by:Clinician judgementA suicide attempt within 6 months of enrollmentActive suicidal ideation at screening or baseline, as indicated by the C-SSRSPrevious intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment, as indicated by the C-SSRSAdditional Exclusion Criteria for Control Participants:Meets DSM-5 criteria for psychotic, bipolar, or autism spectrum disorderHas a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder
Source: ClinicalTrials.gov (NCT05664594). StuddyBuddy aggregates publicly available trial information.