Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05967195 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Trial to Increase FEP Attendance

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Jul 31, 2026 to Dec 31, 2026 Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 9 of 9 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 9 of 9 entries
  2. Completion pushed from Mar 31, 2026 to Jul 31, 2026v12
  3. Primary completion date changed from estimate of Jan 1, 2026 to Dec 18, 2025 Completion date: Jan 31, 2026 to Mar 31, 2026v11 Show 1 more changeShow less
    • Completion date: Jan 31, 2026 to Mar 31, 2026
  4. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Sep 2025 to Jan 1, 2026 · Completion date: Sep 2025 to Jan 31, 2026 · Site details revised at 3 of 3 sitesv10 Show 3 more changesShow less
    • Primary completion date: Sep 2025 to Jan 1, 2026
    • Completion date: Sep 2025 to Jan 31, 2026
    • Site details revised at 3 of 3 sites
  5. Site details revised at 1 of 3 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Start date: Nov 15, 2024 to Feb 1, 2025 · Study sites: 0 to 3 · Primary and study completion dates: Jun 2025 to Sep 2025 · 1 morev8 Show 4 more changesShow less
    • Start date: Nov 15, 2024 to Feb 1, 2025
    • Study sites: 0 to 3
    • Primary and study completion dates: Jun 2025 to Sep 2025
    • Secondary endpoints: details revised at 9 of 9 entries
  2. Start date: Sep 15, 2024 to Nov 15, 2024v7
  3. Start date: Jun 2024 to Sep 15, 2024v6
  4. Start date: Feb 2024 to Jun 2024 Primary and study completion dates: Feb 2025 to Jun 2025v5 Show 1 more changeShow less
    • Primary and study completion dates: Feb 2025 to Jun 2025
  5. Primary and study completion dates: Jul 2024 to Feb 2025 Start date: Nov 2023 to Feb 2024v4 Show 1 more changeShow less
    • Start date: Nov 2023 to Feb 2024
  6. Start date: Aug 2023 to Nov 2023v3
  7. Start date: Jul 2023 to Aug 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05967195
Lead Sponsor University of Pennsylvania
Collaborators: Penn Innovation in Suicide Prevention for Implementation Research (INSPIRE) Center
Conditions First-Episode Psychosis
Enrollment 145 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov