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Trial to Increase FEP Attendance

NCT05967195 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2026-05-11

No results posted yet for this 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

  • First-Episode Psychosis

Interventions

BEHAVIORAL

Financial Incentive and Text-Messages

Patient-participants will receive modest financial incentive for attending therapy or medication management appointments combined with text messages to encourage attendance at these appointments. Text messages will be informed by principles of behavioral economics. Maximum incentive = $50/month if all appointments attended. Incentives will be pro-rated by percentage of appointments attended. Pro-rating strategies (e.g., uniform amount per appointment, escalating \[aka, 'back-loaded'\], or decreasing \[aka 'frontloaded'\] will be sequentially changed based on acceptability and other intervention-related data gathered from participants during the trial. Clinician-participants will not receive any intervention, but will receive surveys and interviews to assess their perceptions about the optimization, acceptability, scalability, and other implementation barriers/facilitators for the intervention.

Sponsors & Collaborators

  • Penn Innovation in Suicide Prevention for Implementation Research (INSPIRE) Center

    collaborator UNKNOWN

  • University of Pennsylvania

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-12-18
Completion
2026-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05967195 on ClinicalTrials.gov