Schizoaffective DisordersTCT FEPNCT07713849
Transition Care for FEP
An observational study of Schizoaffective Disorders and Bipolar Disorder With Psychotic Features, run by University of Chicago at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizoaffective Disorders, Bipolar Disorder With Psychotic Features, Schizophrenia Disorders
- What is being tested?
- Transition Care Team
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 May 2026to 6 May 2029
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Active, not recruiting
University of Chicago Medical Center, Biological Science Division
Chicago, Illinois, 60637
- Recruiting
University of Chicago Ingalls Memorial Hospital
Harvey, Illinois, 60426
Madeline Perez, B.S, 773-712-9178, maddieg@bsd.uchicago.edu
Carolyn Shima, PhD
About this study
Official title: Adapting and Improving Transition Care for First Episode Psychosis
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.
Read the detailed description
For individuals experiencing the onset of a psychotic disorder such as schizophrenia, the period of time around their first hospitalization and subsequent stabilization in outpatient care is a critical juncture for establishing the trajectory of their recovery. Engaging early and consistently in care not only yields more rapid stabilization of symptoms, but it is also associated with improved long-term prognosis and better quality of life. In recent years, the field has focused on developing a gold standard outpatient treatment model for individuals experiencing their first episode of psychosis (FEP), called Coordinated Specialty Care (CSC). This model features wraparound services, shared decision making with the young adult experiencing FEP, peer support, and caregiver engagement. It has been consistently shown to improve outcomes for these individuals. Unfortunately, however, many patients who would qualify for enrollment in CSC programs are unable to benefit from this effective treatment. That is, there is a vulnerable period in between the initial diagnosis and stabilization of a psychotic disorder-often occurring on inpatient care units-and successful engagement in the CSC program. In this vulnerable care transition time, many patients are lost to follow-up, thus losing the treatment gains of acute inpatient care and failing to take advantage of progressing further into recovery via CSCs. The barriers to effective transition between these two treatment settings are numerous: poor insight regarding the need for continued care, inadequate caregiver support, insufficient knowledge of the healthcare system, practical/structural constraints such as lack of transportation, long wait times for the initial appointment, and more. In our own preliminary data from one inpatient unit, 76% of qualifying FEP individuals did not successfully attend an outpatient CSC appointment. Accordingly, there is a significant clinical care gap in practice: CSC may be the best outpatient treatment program for individuals with FEP, but many are unable to benefit as a result of being lost to follow-up. In this project, the investigators will pilot an intervention designed to close this gap. The investigators have adapted the concept of transitional care, used in other medical settings, for hospitalized FEP individuals to facilitate engagement in outpatient CSC care. A Transition Care Team (TCT) will engage with FEP patients before and after hospitalization, incorporating CSC elements such as family engagement, peer support, and case management. Importantly, it will also be resourced to provide interim medication management, transportation, etc., which will be offered until the patient engages with CSC for the next stage of their care. This integrates two established care models-transitional care and CSC-for FEP populations. The investigators expect this approach will be successful by addressing targets at the patient, provider, and system levels.
Given the emphasis on transitional care between acute and outpatient settings, this intervention will begin on the inpatient unit itself shortly after the FEP individual begins to stabilize. In preparation for discharge, the TCT will meet individually with the FEP patient and their caregivers to conduct a needs assessment for the transition period. This team will then continue following the patient after discharge, maintaining contact with the individual, their caregivers, and the CSC program they are referred to, for up to 6 weeks or until attendance of the CSC appointment.
- Conditions
- Schizoaffective Disorders, Bipolar Disorder With Psychotic Features, Schizophrenia Disorders, Major Depressive Disorder With Psychotic Features, Psychosis NOS
- Being tested
- Transition Care Team
- Keywords
- First Episode Psychosis, Bipolar, Inpatient Unit, Transition Care Team, Schizophrenia, Coordinated Specialty Care
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition Care TeamBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Transition Care Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Transition Care Team for First Episode Psychosis
Attendance at 1 or more than 1 CSC appointment within 6 weeks of discharge
Measured: 6 weeks post-discharge
Secondary outcomes (3)
Demographic Factors affecting CSC Engagement
Assessing mechanisms underlying effectiveness of CSC engagement by dividing subjects into those that did attend CSC and those that did not and compare the demographic [sex, age, socioeconomic status] data of patients.
Measured: From enrollment to the end of intervention at 6 week follow up
Symptom Severity/BPRS Score
Assessing mechanisms underlying the effectiveness of CSC engagement by dividing subjects into those that did attend CSC and those that did not attend and compare the symptom severity (BPRS score) at the patient-level.
Measured: From enrollment to the 6 week timepoint.
Barriers to Engagement
Assessing mechanisms underlying effectiveness of CSC engagement by dividing subjects into those that did attend CSC and those that did not attend and compare the needs (family support) and system-level variables including transportation, insurance, etc. that are barriers that can affect attendance.
Measured: From the baseline to 6 week timepoint.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start6 May 2026
- Primary completion6 May 2028 (estimated)
- Study completion6 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Schizoaffective DisordersStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Sidney R. Baer, Jr. Foundation
- Responsible party
- Sponsor
- Investigators
- Molly Erickson, PhD, Principal investigator, University of ChicagoCarolyn Shima, PhD, Principal investigator, University of ChicagoSarah Keedy, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713849
- Sponsor's protocol ID
- IRB25-1866
- Acronym
- TCT FEP
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study
Publications
Ma CF, Chan SKW, Chung YL, Ng SM, Hui CLM, Suen YN, Chen EYH. The predictive power of expressed emotion and its components in relapse of schizophrenia: a meta-analysis and meta-regression. Psychol Med. 2021 Feb;51(3):365-375. doi: 10.1017/S0033291721000209. Epub 2021 Feb 11.
PubMed 33568244Keegan C, Brown K, Gaynor K. A Systematic Review Exploring the Relationship Between Family Factors and Symptom Severity, Relapse and Social or Occupational Functioning in First-Episode Psychosis. Early Interv Psychiatry. 2025 Mar;19(3):e13643. doi: 10.1111/eip.13643. Epub 2025 Jan 8.
PubMed 39779465Villagonzalo KA, Leitan N, Farhall J, Foley F, McLeod B, Thomas N. Development and validation of a scale for self-efficacy for personal recovery in persisting mental illness. Psychiatry Res. 2018 Nov;269:354-360. doi: 10.1016/j.psychres.2018.08.093. Epub 2018 Aug 25.
PubMed 30173041Amador XF, Strauss DH, Yale SA, Flaum MM, Endicott J, Gorman JM. Assessment of insight in psychosis. Am J Psychiatry. 1993 Jun;150(6):873-9. doi: 10.1176/ajp.150.6.873.
PubMed 8494061Schneider LC, Struening EL. SLOF: a behavioral rating scale for assessing the mentally ill. Soc Work Res Abstr. 1983 Fall;19(3):9-21. doi: 10.1093/swra/19.3.9.
PubMed 10264257Humensky JL, Bello I, Malinovsky I, Nossel I, Patel S, Jones G, Cabassa LJ, Radigan M, Sobeih T, Tobey C, Basaraba C, Scodes J, Smith T, Wall M, Labouliere C, Stanley B, Dixon LB. OnTrackNY's learning healthcare system. J Clin Transl Sci. 2020 Apr 6;4(4):301-306. doi: 10.1017/cts.2020.35.
PubMed 33244410Vohs JL, Srihari V, Vinson AH, Lapidos A, Cahill J, Taylor SF, Heckers S, Weiss A, Chaudhry S, Silverstein S, Tso IF, Breitborde NJK, Breier A. The Academic Community Early Psychosis Intervention Network: Toward building a novel learning health system across six US states. Learn Health Syst. 2024 Nov 17;9(2):e10471. doi: 10.1002/lrh2.10471. eCollection 2025 Apr.
PubMed 40247900Tryon VL, Nye KE, Savill M, Loewy R, Miles MJ, Tully LM, Padovani AJ, Tancredi DJ, Melnikow J, Ereshefsky S, Sharma N, McNamara AP, Kado-Walton M, Hakusui CK, Miller C, Nguyen KLH, Safdar M, Padilla VE, Smith L, Wilcox AB, Banks LM, Hayes SL, Pierce KM, Muro K, Shapiro DI, Bolden-Thompson KA, Botello RM, Grattan RE, Zhang Y, Hotz B, Dixon L, Carter CS, Niendam TA. The California collaborative network to promote data driven care and improve outcomes in early psychosis (EPI-CAL) project: rationale, background, design and methodology. BMC Psychiatry. 2024 Nov 14;24(1):800. doi: 10.1186/s12888-024-06245-6.
PubMed 39543502Dow JF, Cerundolo N, Konstas K, Carol EE, Johnson KA, Keshavan MS, Ongur D. Implementing early psychosis services: Experiences from the laboratory for early psychosis center. Schizophr Res. 2025 Mar;277:124-129. doi: 10.1016/j.schres.2025.02.016. Epub 2025 Mar 7.
PubMed 40056755Calkins ME, Jumper M, Ered A, Dong F, Sarpal DK, Baker KK, Bencivengo DJ, Margolis RL, Buchanan RW, Boumaiz Y, Burris E, Campbell PD, Chengappa KNR, Conroy C, Cooke A, Dickerson F, Flowers N, Fauble M, Goldberg RW, Harvin A, Howell C, Kelly C, Kreyenbuhl J, Li L, Lucksted A, Marsteller JA, Moxam A, Namowicz D, Nayar S, Oko J, Riggs J, Saravana A, Scheinberg R, Smith WR, States R, Suhail-Sindhu T, Taylor J, Vatza CL, Wolcott M, Kohler CG, Bennett ME. Connection Learning Healthcare System Hub of the Early Psychosis Intervention Network: Program and Participant Characteristics. Early Interv Psychiatry. 2025 Apr;19(4):e70031. doi: 10.1111/eip.70031.
PubMed 40175161Gleeson JFM, Ludwig K, Stiles BJ, Piantella S, McNab C, Cotton S, Fraser MI, Alvarez-Jimenez M, Watson A, Fraser E, Penn DL. Systematic review and meta-analysis of family-based interventions for early psychosis: Carer and patient outcomes. Schizophr Res. 2025 Feb;276:57-78. doi: 10.1016/j.schres.2025.01.006. Epub 2025 Jan 23.
PubMed 39854977Bebbington P, Kuipers L. The predictive utility of expressed emotion in schizophrenia: an aggregate analysis. Psychol Med. 1994 Aug;24(3):707-18. doi: 10.1017/s0033291700027860.
PubMed 7991753Sheehan KJ, Bastas D, Guerra S, Creanor S, Hulme C, Lamb S, Martin FC, Sackley C, Smith T, Bell P, Hillsdon M, Pope S, Cook H, Godfrey E. Protocol for a feasibility randomised controlled trial of the 'Outdoor' mobility intervention for older adults after hip fracture. PLoS One. 2024 Aug 12;19(8):e0306871. doi: 10.1371/journal.pone.0306871. eCollection 2024.
PubMed 39133712Unick JL, Duffy C, Dizon D, Fenton MA, Cao Z, Oselinsky K, Tobin SY, Wing RR. Evaluation of a Translatable Web-Based Intervention for Increasing Physical Activity Among Cancer Survivors: Pilot Randomized Trial. JMIR Cancer. 2025 Oct 2;11:e79610. doi: 10.2196/79610.
PubMed 41037739Brown H, Ongur D, Smurawska L, Valcourt S. Inpatient - Outpatient transitions in first episode psychosis care. Schizophr Res. 2022 Dec;250:123-124. doi: 10.1016/j.schres.2022.10.014. Epub 2022 Nov 17. No abstract available.
PubMed 36401993
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Improving Transition Care for First Episode Psychosis
- ClinicalTrials.gov ID
- NCT07713849
- Acronym / sponsor ID
- TCT FEP / IRB25-1866
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Sidney R. Baer, Jr. Foundation
- Study start
- 6 May 2026 (actual)
- Primary completion
- 6 May 2028 (estimated)
- Study completion
- 6 May 2029 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For individuals experiencing the onset of a psychotic disorder such as schizophrenia, the period of time around their first hospitalization and subsequent stabilization in outpatient care is a critical juncture for establishing the trajectory of their recovery. Engaging early and consistently in care not only yields more rapid stabilization of symptoms, but it is also associated with improved long-term prognosis and better quality of life. In recent years, the field has focused on developing a gold standard outpatient treatment model for individuals experiencing their first episode of psychosis (FEP), called Coordinated Specialty Care (CSC). This model features wraparound services, shared decision making with the young adult experiencing FEP, peer support, and caregiver engagement. It has been consistently shown to improve outcomes for these individuals. Unfortunately, however, many patients who would qualify for enrollment in CSC programs are unable to benefit from this effective treatment. That is, there is a vulnerable period in between the initial diagnosis and stabilization of a psychotic disorder-often occurring on inpatient care units-and successful engagement in the CSC program. In this vulnerable care transition time, many patients are lost to follow-up, thus losing the treatment gains of acute inpatient care and failing to take advantage of progressing further into recovery via CSCs. The barriers to effective transition between these two treatment settings are numerous: poor insight regarding the need for continued care, inadequate caregiver support, insufficient knowledge of the healthcare system, practical/structural constraints such as lack of transportation, long wait times for the initial appointment, and more. In our own preliminary data from one inpatient unit, 76% of qualifying FEP individuals did not successfully attend an outpatient CSC appointment. Accordingly, there is a significant clinical care gap in practice: CSC may be the best outpatient treatment program for individuals with FEP, but many are unable to benefit as a result of being lost to follow-up. In this project, the investigators will pilot an intervention designed to close this gap. The investigators have adapted the concept of transitional care, used in other medical settings, for hospitalized FEP individuals to facilitate engagement in outpatient CSC care. A Transition Care Team (TCT) will engage with FEP patients before and after hospitalization, incorporating CSC elements such as family engagement, peer support, and case management. Importantly, it will also be resourced to provide interim medication management, transportation, etc., which will be offered until the patient engages with CSC for the next stage of their care. This integrates two established care models-transitional care and CSC-for FEP populations. The investigators expect this approach will be successful by addressing targets at the patient, provider, and system levels.
Given the emphasis on transitional care between acute and outpatient settings, this intervention will begin on the inpatient unit itself shortly after the FEP individual begins to stabilize. In preparation for discharge, the TCT will meet individually with the FEP patient and their caregivers to conduct a needs assessment for the transition period. This team will then continue following the patient after discharge, maintaining contact with the individual, their caregivers, and the CSC program they are referred to, for up to 6 weeks or until attendance of the CSC appointment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with First Episode Psychosis | – | Behavioral: Transition Care TeamAdults 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transition Care TeamThe 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. | Behavioural | Individuals with First Episode Psychosis |
Primary outcome
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
3 secondary outcomes
Demographic Factors affecting CSC Engagement
Time frame: From enrollment to the end of intervention at 6 week follow up
Symptom Severity/BPRS Score
Time frame: From enrollment to the 6 week timepoint.
Barriers to Engagement
Time frame: From the baseline to 6 week timepoint.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 33568244Ma CF, Chan SKW, Chung YL, Ng SM, Hui CLM, Suen YN, Chen EYH. The predictive power of expressed emotion and its components in relapse of schizophrenia: a meta-analysis and meta-regression. Psychol Med. 2021 Feb;51(3):365-375. doi: 10.1017/S0033291721000209. Epub 2021 Feb 11.
- Background: PubMed 39779465Keegan C, Brown K, Gaynor K. A Systematic Review Exploring the Relationship Between Family Factors and Symptom Severity, Relapse and Social or Occupational Functioning in First-Episode Psychosis. Early Interv Psychiatry. 2025 Mar;19(3):e13643. doi: 10.1111/eip.13643. Epub 2025 Jan 8.
- Background: PubMed 30173041Villagonzalo KA, Leitan N, Farhall J, Foley F, McLeod B, Thomas N. Development and validation of a scale for self-efficacy for personal recovery in persisting mental illness. Psychiatry Res. 2018 Nov;269:354-360. doi: 10.1016/j.psychres.2018.08.093. Epub 2018 Aug 25.
- Background: PubMed 8494061Amador XF, Strauss DH, Yale SA, Flaum MM, Endicott J, Gorman JM. Assessment of insight in psychosis. Am J Psychiatry. 1993 Jun;150(6):873-9. doi: 10.1176/ajp.150.6.873.
- Background: PubMed 10264257Schneider LC, Struening EL. SLOF: a behavioral rating scale for assessing the mentally ill. Soc Work Res Abstr. 1983 Fall;19(3):9-21. doi: 10.1093/swra/19.3.9.
- Background: PubMed 33244410Humensky JL, Bello I, Malinovsky I, Nossel I, Patel S, Jones G, Cabassa LJ, Radigan M, Sobeih T, Tobey C, Basaraba C, Scodes J, Smith T, Wall M, Labouliere C, Stanley B, Dixon LB. OnTrackNY's learning healthcare system. J Clin Transl Sci. 2020 Apr 6;4(4):301-306. doi: 10.1017/cts.2020.35.
- Background: PubMed 40247900Vohs JL, Srihari V, Vinson AH, Lapidos A, Cahill J, Taylor SF, Heckers S, Weiss A, Chaudhry S, Silverstein S, Tso IF, Breitborde NJK, Breier A. The Academic Community Early Psychosis Intervention Network: Toward building a novel learning health system across six US states. Learn Health Syst. 2024 Nov 17;9(2):e10471. doi: 10.1002/lrh2.10471. eCollection 2025 Apr.
- Background: PubMed 39543502Tryon VL, Nye KE, Savill M, Loewy R, Miles MJ, Tully LM, Padovani AJ, Tancredi DJ, Melnikow J, Ereshefsky S, Sharma N, McNamara AP, Kado-Walton M, Hakusui CK, Miller C, Nguyen KLH, Safdar M, Padilla VE, Smith L, Wilcox AB, Banks LM, Hayes SL, Pierce KM, Muro K, Shapiro DI, Bolden-Thompson KA, Botello RM, Grattan RE, Zhang Y, Hotz B, Dixon L, Carter CS, Niendam TA. The California collaborative network to promote data driven care and improve outcomes in early psychosis (EPI-CAL) project: rationale, background, design and methodology. BMC Psychiatry. 2024 Nov 14;24(1):800. doi: 10.1186/s12888-024-06245-6.
- Background: PubMed 40056755Dow JF, Cerundolo N, Konstas K, Carol EE, Johnson KA, Keshavan MS, Ongur D. Implementing early psychosis services: Experiences from the laboratory for early psychosis center. Schizophr Res. 2025 Mar;277:124-129. doi: 10.1016/j.schres.2025.02.016. Epub 2025 Mar 7.
- Background: PubMed 40175161Calkins ME, Jumper M, Ered A, Dong F, Sarpal DK, Baker KK, Bencivengo DJ, Margolis RL, Buchanan RW, Boumaiz Y, Burris E, Campbell PD, Chengappa KNR, Conroy C, Cooke A, Dickerson F, Flowers N, Fauble M, Goldberg RW, Harvin A, Howell C, Kelly C, Kreyenbuhl J, Li L, Lucksted A, Marsteller JA, Moxam A, Namowicz D, Nayar S, Oko J, Riggs J, Saravana A, Scheinberg R, Smith WR, States R, Suhail-Sindhu T, Taylor J, Vatza CL, Wolcott M, Kohler CG, Bennett ME. Connection Learning Healthcare System Hub of the Early Psychosis Intervention Network: Program and Participant Characteristics. Early Interv Psychiatry. 2025 Apr;19(4):e70031. doi: 10.1111/eip.70031.
- Background: PubMed 39854977Gleeson JFM, Ludwig K, Stiles BJ, Piantella S, McNab C, Cotton S, Fraser MI, Alvarez-Jimenez M, Watson A, Fraser E, Penn DL. Systematic review and meta-analysis of family-based interventions for early psychosis: Carer and patient outcomes. Schizophr Res. 2025 Feb;276:57-78. doi: 10.1016/j.schres.2025.01.006. Epub 2025 Jan 23.
- Background: PubMed 7991753Bebbington P, Kuipers L. The predictive utility of expressed emotion in schizophrenia: an aggregate analysis. Psychol Med. 1994 Aug;24(3):707-18. doi: 10.1017/s0033291700027860.
- Individual participant dataSharing planned: No. This is a pilot study
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Schizophenia Disorder, Severe Mental Illness
Not yet recruiting
A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness
Severe Mental Illness, Bipolar Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Molly Erickson, PhD principal investigator
University of Chicago
Carolyn Shima, PhD principal investigator
University of Chicago
Sarah Keedy, PhD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizoaffective Disorders and Bipolar Disorder With Psychotic Features, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeline Perez Lab Manager, B.S (773-712-9178, keedylab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Transition Care Team for First Episode Psychosis (time frame: 6 weeks post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07713849, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.