Transition Care for FEP
Recruiting · NCT07713849 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Chicago
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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.
Who can take part
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 it is running
4 locations listed across 1 US state.
- University of Chicago Medical Center, Biological Science Division - Chicago, Illinois, United States
- University of Chicago Medical Center, Biological Science Division - Chicago, Illinois, United States
- University of Chicago Ingalls Memorial Hospital - Harvey, Illinois, United States
- University of Chicago Ingalls Memorial Hospital - Harvey, Illinois, United States