COMPLETED

State Representation in Early Psychosis - Project 4

Conditions

Psychosis Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizoaffective Disorder Cognitive Training Magnetic Resonance Imaging (MRI)Electroencephalography (EEG)State Representation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

State Representation in Early Psychosis - Project 4

Quick Facts

Study Start:2022-07-31

Study Completion:2025-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05664594

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* English proficiency, as determined by staff observation and participant self-report * Estimated IQ at or above 70, as estimated by the cognitive assessments * 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	* 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) * 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 * Meets criteria for clinical risk of suicidal behavior, as defined by: * 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 * 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

Inclusion Criteria

Exclusion Criteria

* English proficiency, as determined by staff observation and participant self-report
* Estimated IQ at or above 70, as estimated by the cognitive assessments
* 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

* 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)
* 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
* Meets criteria for clinical risk of suicidal behavior, as defined by:
* 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
* 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

Contacts and Locations

Principal Investigator

Sophia Vinogradov, MD

PRINCIPAL_INVESTIGATOR

University of Minnesota

Angus MacDonald III, Ph.D.

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

University of Minnesota

Minneapolis, Minnesota, 55454

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Sophia Vinogradov, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota
Angus MacDonald III, Ph.D., PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-31

Study Completion Date2025-10-31

Study Record Updates

Study Start Date2022-07-31

Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

Cognitive Training
Magnetic Resonance Imaging (MRI)
Electroencephalography (EEG)
State Representation

Additional Relevant MeSH Terms

Psychosis
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Schizoaffective Disorder