ACTIVE_NOT_RECRUITING

EPI-MINN: Targeting Cognition and Motivation

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Conditions

PsychosisCognitive TrainingMotivation EnhancementFirst Episode PsychosisSchizophrenia Spectrum Disorders

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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 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. Participants who are enrolled in a chart review study of measurement-based care will be recruited to participate in this study. In the measurement-based care study, participants are enrolled in coordinated specialty care programs for early psychosis that provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, work or education support, and measurement-based care. Participants will complete a set of well-defined measures every 6 months that assess symptoms, functioning, cognition and motivation as standard of care. The current study will utilize the data acquired in the measurement-based care study. 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. The investigators will test for differences in the clinical trajectories over 18 months in those who receive the intervention vs. those who do not. This study will be conducted jointly with a sister protocol under a separate NCT listing. This iteration will be conducted locally within the EPI-MINN Network, while the other project will be conducted on a national scale.

Official Title

EPI-MINN: Targeting Cognition and Motivation in Coordinated Specialty Care for Early Psychosis

Quick Facts

Study Start:2021-08-12
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05112432

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. * Enrolled in EPI-MINN: Measurement Based Care protocol, STUDY00009334
  2. * 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)
  3. * Estimated IQ at or above 70, as estimated by the Penn CNP Matrix Reasoning Test
  4. * 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)
  5. * Has access to a smartphone or other mobile device to use the PRIME app
  1. * 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
  2. * Participated in significant cognitive training programs within the last three years
  3. * Diagnosed with a neurological disorder (Autism Spectrum Disorder is allowed)
  4. * 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)
  5. * Risk of suicidal behavior, as indicated by the clinicall obtained C-SSRS or clinician judgement. Risk of suicidal behavior is defined as:
  6. * Active suicidal ideation at screening or baseline, or
  7. * Previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months

Contacts and Locations

Principal Investigator

Sophia Vinogradov, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota Department of Psychiatry and Behavioral Sciences

Study Locations (Sites)

Human Development Center
Duluth, Minnesota, 55805
United States
Hennepin Healthcare
Minneapolis, Minnesota, 55404
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Sophia Vinogradov, MD, 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 Date2021-08-12
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-08-12
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Psychosis