Financial Incentives for First Episode Psychosis

Recruiting at 3 trial locations

Overseen By Willam R Smith, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Pennsylvania

Disqualifiers: Intellectual disability, Secondary psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

145 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with first-episode psychosis enrolled in Coordinated Specialty Care at PEACE and PERC clinics. It's also for clinicians at these sites, plus those from other Connection LHS sites to assess scalability. Participants must consent to join.

Inclusion Criteria

Clinicians employed at PEACE and PERC sites will be evaluated for their capability to implement the intervention.

Patients with initial psychotic episodes, enrolled in the PEACE and PERC Coordinated Specialty Care services, will be assessed for their suitability and acceptability of intervention trials.

Clinicians in Connection LHS who are based at sites other than PEACE and PERC must assess facilitators and barriers to implementation, as well as the potential scalability of the project

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 months

1 visit (in-person)

Intervention Period 1

First intervention period with financial incentives to encourage treatment engagement

3 months

Regular visits as per CSC program schedule

Intervention Period 2

Second intervention period with modifications based on prior findings

3 months

Regular visits as per CSC program schedule

Intervention Period 3

Third intervention period with further modifications based on prior findings

3 months

Regular visits as per CSC program schedule

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 months

Treatment Details

Trial Overview The study is testing a program that offers financial incentives to encourage patients with first-episode psychosis to stay engaged in their treatment. The pilot will involve modifications over three periods based on feedback aiming to improve the intervention.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

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

Collaborator

Trials

1

Recruited

150+