Transition Care for FEP

NCT07713849 | Recruiting

• 1 other identifier: IRB25-1866
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

This study is testing a new approach to help people with first episode psychosis transition successfully from the hospital to outpatient mental health care. Many patients lose contact with services after they leave the hospital, which can lead to worse outcomes. The investigators have developed a Transition Care Team (TCT) that works with patients while they are in the hospital and continues to support them after discharge. The team provides therapy, case management, and coordination with community programs that offer ongoing care. The main goal of the study is to find out if this new program increases the number of patients who successfully begin outpatient treatment after hospitalization, compared to usual care. The investigators will also look at whether the program improves symptoms, functioning, and overall well-being.

Conditions

Schizoaffective Disorders; Bipolar Disorder With Psychotic Features; Schizophrenia Disorders; Major Depressive Disorder With Psychotic Features; Psychosis NOS

Keywords

First Episode Psychosis; Bipolar; Inpatient Unit; Transition Care Team; Schizophrenia; Coordinated Specialty Care

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Transition Care Team for First Episode Psychosis

  Attendance at 1 or more than 1 CSC appointment within 6 weeks of discharge

  6 weeks post-discharge

Secondary Outcomes (3)

• Demographic Factors affecting CSC Engagement

  From enrollment to the end of intervention at 6 week follow up

• Symptom Severity/BPRS Score

  From enrollment to the 6 week timepoint.

• Barriers to Engagement

  From the baseline to 6 week timepoint.

Study Arms (1)

Individuals with First Episode Psychosis

Adults ages 18-40 admitted o an inpatient psychiatric unit with a first episode of psychosis (onset within prior 2 years) who received the Transition Care Team (TCT-FEP) intervention from hospitalization through to 6 weeks post-discharge

Behavioral: Transition Care Team

Interventions

Transition Care Team BEHAVIORAL

The novel intervention is the Transition Care Team (TCT), a multidisciplinary clinical support model designed to improve continuity of care for individuals experiencing a first episode of psychosis. The TCT provides short-term post-discharge services, including psychoeducation, case management, peer support, and coordination with outpatient programs until participants are established in Coordinated Specialty Care (CSC). This differs from standard care, where patients typically receive discharge referrals without structured follow-up. The intervention itself uses evidence-based clinical practices but applies them in a new, transitional format for this population, which is not currently part of standard inpatient-to-outpatient care at UChicago or Ingalls.

Individuals with First Episode Psychosis

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from those admitted to the psychiatry units in the Wyman Gordon building at University of Chicago Ingalls Memorial hospital.

You may qualify if:

• Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, major depressive disorder with psychotic features, schizophreniform disorder, or psychosis NOS
• The diagnosis of one of the psychotic disorders has a duration of less than two years.
• Able to read, speak, and understand English, which will be assessed through observation.
• Able and willing to provide written informed consent or assent, in cases where caregivers are considered legal guardians. Dr. Shima, co-I of the study, is a forensic psychiatrist, and particularly adept at judging such ability. Drs. Erickson and Keedy have conducted studies in individuals with psychotic disorders, including FEP and in the context of clinical trials, for years, and are similarly competent to judge whether individuals can provide informed consent. Finally, we will also use an Evaluation to Sign Consent form that documents subjects' verbalized understanding of key aspects of the study.
• have an estimated IQ of \> 65, assessed by the Wechsler Test of Adult Reading
• Eligible caregivers/proxy informants must be identified by the participant or clinical team as being involved in the participant's discharge planning or follow-up care, be able to provide informed verbal consent, and be able to speak and read English sufficiently to complete study questionnaires. Caregivers may include family members, close supports, or legally authorized representatives.

You may not qualify if:

• Individuals with substance-induced psychosis or psychosis due to a medical condition will not be included in the study. We will use the Structured Clinical Interview for DSM-5 as well as medical records, and if the subject gives permission, caregiver information in this process
• Individuals who do not meet criteria for a first episode of psychosis

Sponsors & Collaborators

• University of Chicago: lead
• Sidney R. Baer, Jr. Foundation: collaborator

Study Sites (2)

University of Chicago Medical Center, Biological Science Division

Chicago, Illinois, 60637, United States

ACTIVE NOT RECRUITING

University of Chicago Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

RECRUITING

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MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Molly Erickson, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Carolyn Shima, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Sarah Keedy, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline Perez Lab Manager, B.S

CONTACT

773-712-9178; keedylab@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 20, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): May 6, 2028
• Study Completion (Estimated): May 6, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)