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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 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.

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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.

Conditions Studied

First Episode Psychosis

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

FieldValue
Enrollment Target 145 participants
Start Date 2025-02-01
Est. Completion 2026-03-31
Phase Early Phase 1

Sponsor

University of Pennsylvania

1,423 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05967195

The ClinicalTrials.gov registry entry for NCT05967195 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,415-participant average among 8 other First Episode Psychosis trials with a reported enrollment target (98% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.