Improving cognition and motivation in early psychosis
EPI-MINN: Targeting Cognition and Motivation in Coordinated Specialty Care for Early Psychosis
This study is testing a 12-week mobile program to see if it can help people with early psychosis improve their thinking skills and motivation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 15 Years to 40 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 3 sites (Duluth, Minnesota and 2 other locations) |
| Trial ID | NCT05112432 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance cognitive function and motivation in individuals experiencing early psychosis through a 12-week mobile intervention program. Participants, who are already enrolled in a measurement-based care protocol, will receive cognitive and social cognitive training along with personalized real-time motivational enhancement via a mobile app. The study builds on previous findings that suggest addressing cognitive dysfunction and motivation can significantly improve long-term outcomes for individuals with psychosis. Data collected from standard care assessments will be utilized to evaluate the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with early psychosis who are clinically stable and enrolled in a measurement-based care program.
Not a fit: Patients who are under legal commitment to treatment or have significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved cognitive abilities and motivation in patients with early psychosis, enhancing their overall functioning and quality of life.
How similar studies have performed: Previous studies have shown promising results in improving cognitive function in early psychosis, indicating that this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Enrolled in EPI-MINN: Measurement Based Care protocol, STUDY00009334 * Good general health (i.e. not acutely ill or experiencing a severe/chronic illness that would impede their ability to complete study activities. This determination shall be, if necessary, made at the discretion of the PIs) * Estimated IQ at or above 70, as estimated by the Penn CNP Matrix Reasoning Test * Achieved clinical stability, defined as outpatient status for at least one month prior to study participation and clinically stable doses of psychiatric medication (by PI discretion) for at least one month prior to study participation (including no medication) * Has access to a smartphone or other mobile device to use the PRIME app Exclusion Criteria: * Under legal commitment to treatment or is under medical guardianship, and there is no provision in the guardianship order or a court order to allow the guardian to consent to participation in research * Participated in significant cognitive training programs within the last three years * Diagnosed with a neurological disorder (Autism Spectrum Disorder is allowed) * Clinically significant substance abuse that is impeding the participant's abulity to participate fully during recruitment, enrollment, assessment, or training, (is unable to remain sober for assessments and training) * Risk of suicidal behavior, as indicated by the clinicall obtained C-SSRS or clinician judgement. Risk of suicidal behavior is defined as: * Active suicidal ideation at screening or baseline, or * Previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months
Where this trial is running
Duluth, Minnesota and 2 other locations
- Human Development Center — Duluth, Minnesota, United States (Recruiting)
- Hennepin Healthcare — Minneapolis, Minnesota, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Sophia Vinogradov, MD — University of Minnesota Department of Psychiatry and Behavioral Sciences
- Study coordinator: Nate Olinger
- Email: epinetrct@umn.edu
- Phone: (612) 403-4587
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.