Examining cognitive training in individuals with early psychosis
State Representation in Early Psychosis - Project 4
This study is testing whether a computer-based brain training program can help young people with early psychosis improve their thinking skills and how their brains work.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 15 Years to 45 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05664594 on ClinicalTrials.gov |
What this trial studies
This study investigates state representation in individuals aged 15-45 diagnosed with psychotic disorders and demographically matched individuals without psychiatric diagnoses. Participants will undergo 10 hours of computerized cognitive training over 3-6 weeks, followed by assessments including interviews, self-report questionnaires, and neurocognitive evaluations. The study utilizes EEG and fMRI imaging to analyze brain activity during cognitive tasks, aiming to understand the effects of cognitive training on state representation. This is a continuation of a previous study, using baseline data from earlier assessments.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 15-45 with a clinical diagnosis of schizophrenia or related disorders, as well as demographically matched individuals without psychiatric diagnoses.
Not a fit: Patients who are unable to provide informed consent or have contraindications for MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cognitive functioning and improve the quality of life for individuals with early psychosis.
How similar studies have performed: Previous studies have shown promise in cognitive training approaches for psychosis, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Sophia Vinogradov, MD — University of Minnesota
- Study coordinator: Liberty Holmberg Kohler, BA
- Email: step-phase2@umn.edu
- Phone: 612-772-2201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.