ACTIVE_NOT_RECRUITING

EPI-MINN: Targeting Cognition and Motivation - National

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 perform a practice-based research project designed to assess whether cognition and motivated behavior in early psychosis can be addressed as key treatment goals within real-world settings by using a 12-week mobile intervention program. We will recruit participants who are receiving care for early psychosis from clinics across the United States. We will compare outcomes from participants who receive treatment at coordinated specialty care (CSC) early psychosis clinics to those that receive standard community care. A qualifying CSC program will provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, and work or education support. This study will be conducted remotely, and participants can participate at home with their own electronic devices. The aim of this study is to investigate a well-defined 12-week mobile intervention program specifically designed to target cognitive functioning and motivated behavior for individuals with early psychosis. Participants will complete a screening interview which will include diagnosis and symptom ratings, neurocognitive assessment, and self-reports of symptoms, behavior, and functioning. Then participants will be randomized to receive the 12-week mobile intervention, or an active control of treatment as usual. The investigators will test for differences in the clinical trajectories after training, and at two follow up appointments at 6 and 12 months post-training.

Official Title

EPI-MINN: Targeting Cognition and Motivation in Coordinated Specialty Care for Early Psychosis: A National Comparison Study

Quick Facts

Study Start:2023-05-30
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05877716

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 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 15-40 (inclusive)
  2. * Is enrolled in an early psychosis coordinated specialty care clinic, or is receiving services by a mental health care professional.
  3. * Symptoms of psychosis started within the last 5 years
  4. * Is in good general physical health (e.g., not acutely ill or experiencing a sever/chronic illness that would impede their ability to complete study activities)
  5. * Fluent in spoken and written English
  6. * Estimated IQ at or above 70, as estimated by the Test My Brain matrices task
  7. * Participants will show overall clinical stability as determined by interview measures. Generally, participants who have not been hospitalized within the last 30 days, who have not had significant changes to medications, and do not have active suicidal ideation will be considered stable.
  8. * Has access to a smart phone or other mobile device to use the PRIME App
  9. * Has access to a computer or tablet to complete cognitive training exercises and study assessments
  1. * Unable to provide informed consent (i.e., cannot pass UBACC assessment)
  2. * Participant is under legal commitment to treatment or is under medical guardianship
  3. * Participated in significant cognitive training programs within the last 3 years
  4. * Diagnosed with a neurological disorder that may interfere with participation in the study
  5. * Clinically significant substance abuse that is impeding the participant's ability to participate fully during enrollment, assessment, or training (i.e., is unable to remain sober)
  6. * Risk of suicidal behavior

Contacts and Locations

Principal Investigator

Sophia Vinogradov, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota Department of Psychiatry and Behavioral Sciences
Piper Meyer-Kalos, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota Department of Psychiatry and Behavioral Sciences

Study Locations (Sites)

University of Minnesota Department of Psychiatry & Behavioral Sciences
Minneapolis, Minnesota, 55454
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Sophia Vinogradov, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota Department of Psychiatry and Behavioral Sciences
  • Piper Meyer-Kalos, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota Department of Psychiatry and Behavioral Sciences

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 Date2023-05-30
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-05-30
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Cognitive Training
  • Motivation Enhancement
  • First Episode Psychosis
  • Schizophrenia Spectrum Disorders
  • Remote

Additional Relevant MeSH Terms

  • Psychosis
  • Psychosis Nos/Other
  • Schizophrenia
  • Schizo Affective Disorder
  • Schizoaffective Disorder
  • Prodromal Schizophrenia
  • Schizophrenia Spectrum and Other Psychotic Disorders
  • Schizophreniform Disorders
  • Major Depression With Psychotic Features
  • Unspecified Psychosis
  • Bipolar Disorder