Status:
ACTIVE_NOT_RECRUITING
Trial to Increase FEP Attendance
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Penn Innovation in Suicide Prevention for Implementation Research (INSPIRE) Center
Conditions:
First-Episode Psychosis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Individuals with first-episode psychosis (FEP) are at high-risk for several poor functional and clinical outcomes, including suicide. Coordinated Specialty Care (CSC) is a multidisciplinary, team-base...
Eligibility Criteria
Inclusion
- For all participants, age ≥ 18 years old.
- For intervention trial and patient feasibility and acceptability measurement: Patients with first-episode psychosis, enrolled in Coordinated Specialty Care at the Psychosis Education, Assessment, Care and Empowerment (PEACE) clinic and Psychosis Evaluation and Recovery Center (PERC).
- For clinician feasibility and acceptability measurement at intervention sites: Clinicians working at PEACE and PERC where the intervention will be piloted.
- For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: Clinicians in Connection LHS who work at sites other than PEACE and PERC.Participants must sign the informed consent form
Exclusion
- For intervention trial and patient feasibility and acceptability measurement: Expectation of leaving coordinated specialty care programing within 6 months (which will exclude all of the PI's patient panel) and/or intellectual disability of sufficient degree that the patient's primary psychiatrist expects to compromise capacity to consent to this research and/or psychosis secondary to another medical condition (which may not share the same motivational features that are otherwise understood about the primary psychiatric conditions with psychosis).
- For clinician feasibility and acceptability measurement at intervention sites: Study investigators who work at these clinics will be excluded from participation in the feasibility and acceptability study component given their role in the trial planning and execution.
- For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: none.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT05967195
Start Date
February 1 2025
End Date
January 31 2026
Last Update
December 12 2025
Active Locations (3)
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1
University of North Carolina at Chapel Hill (ENCOMPASS Program)
Raleigh, North Carolina, United States, 27608
2
PEACE Program, Horizon House, Inc.
Philadelphia, Pennsylvania, United States, 19123
3
University of Pennsylvania
Philadephia, Pennsylvania, United States, 19104