NCT07713849 · University of Chicago
Transition Care for FEP
(TCT FEP)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Transition Care Team
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.
Primary outcome measures
Effectiveness of Transition Care Team for First Episode Psychosis
Time frame: 6 weeks post-discharge
Attendance at 1 or more than 1 CSC appointment within 6 weeks of discharge
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
Where
- Chicago, Illinois
- Harvey, Illinois
Collaborators
Sidney R. Baer, Jr. Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2026 · Source of record for eligibility and locations