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NCT05967195 · ClinicalTrials.gov registry record · Early Phase 1
Trial to Increase FEP Attendance
A Early Phase 1 study of First Episode Psychosis, sponsored by University of Pennsylvania.
- Active
- Registry status
- Early Phase 1
- Development phase
- 145
- Enrollment target
- 3
- Study locations
NCT05967195: Active Early Phase 1 study of First Episode Psychosis, sponsored by University of Pennsylvania.
NCT05967195 is a Early Phase 1 study of First Episode Psychosis that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 145 participants, below the 6,415-participant average among 8 other First Episode Psychosis trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05967195, a Early Phase 1 study of First Episode Psychosis, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 145 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Financial Incentive and Text-Messages
Study Locations (3)
Pennsylvania
- PEACE Program, Horizon House, Inc. - Philadelphia
- University of Pennsylvania - Philadephia
North Carolina
- University of North Carolina at Chapel Hill (ENCOMPASS Program) - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2025-02-01 |
| Est. Completion | 2026-03-31 |
| Phase | Early Phase 1 |
What the registry record for NCT05967195 still lists
NCT05967195 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 6,415-participant average among 8 other First Episode Psychosis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with First Episode Psychosis appearing as the primary indexed condition, and to 1 intervention - of which Financial Incentive and Text-Messages is the first listed.
NCT05967195 reports a single indexed study location in Pennsylvania, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05967195 about?
NCT05967195 is a clinical study titled "Trial to Increase FEP Attendance". 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 d...
What is the current status of trial NCT05967195?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 145 participants. The study started on 2025-02-01. Estimated completion is 2026-03-31.
What conditions does trial NCT05967195 study?
This clinical trial studies the following conditions: First Episode Psychosis.
What interventions are being tested in trial NCT05967195?
The interventions under investigation include: Financial Incentive and Text-Messages (BEHAVIORAL).
Who is sponsoring clinical trial NCT05967195?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05967195 being conducted?
This trial has 3 study locations across North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05967195's enrollment target sits among peer trials
145 6th of 8 higher than 3 of 8 other First Episode Psychosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other First Episode Psychosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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