Trial to Increase FEP Attendance

Early Phase 1

Recruiting

• Conditions: First-Episode Psychosis

• Registration Number: NCT05967195
• Lead Sponsor: University of Pennsylvania

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-based intervention known to improve such outcomes, including suicide risk. However, 30-50% of patients disengage from CSC, thereby limiting its impact. This pilot study will develop and test feasibility of a behavioral change program that uses moderate financial incentives to encourage treatment engagement in 2 CSC programs. A single-arm of 80 patient-participants at these two clinics will be recruited to assess feasibility and acceptability from patient perspectives. Additionally,15 clinicians at these two clinics will be recruited to assess feasibility and acceptability from clinician perspectives, and 50 clinicians from peer clinics not involved in the intervention will be recruited to assess scalability of the intervention. The trial will feature an three-month period for recruitment and baseline data collection and will subsequently feature three intervention periods (3 months each) where modifications to the interventions will be tested (each informed by the feasibility and acceptability findings of the prior period) with the aim of sequentially improving it.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-01
• Study Start: 2025-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

1. For all participants, age ≥ 18 years old.
2. 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).
3. For clinician feasibility and acceptability measurement at intervention sites: Clinicians working at PEACE and PERC where the intervention will be piloted.
4. 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 Criteria

1. 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).
2. 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.
3. For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: none.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acceptability of intervention measure (AIM)	Change at 4 months	The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.
Feasibility of intervention measure (FIM)	Change at 4 months	The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.

Secondary Outcome Measures

Name	Time	Method
Implementation Survey Response	Change at 4 months	Implementation survey. Results will be used to optimize intervention from implementation perspective.
Motivation Survey Response	Change at 4 months	Motivation survey. Results will be used to optimize intervention from motivation perspective.
Ethical Concern Survey Response	Change at 4 months	Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.

Trial Locations

Locations (3)

University of North Carolina at Chapel Hill (ENCOMPASS Program); 🇺🇸 Raleigh, North Carolina, United States

PEACE Program, Horizon House, Inc.; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadephia, Pennsylvania, United States