Trial to Increase FEP Attendance

NCT05967195 | Active Not Recruiting Early Phase 1

• 1 other identifier: 2023-03
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (6)

• Acceptability of intervention measure (AIM)

  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.

  Change at 8 months

• Acceptability of intervention measure (AIM)

  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.

  Change at 6 months

• Acceptability of intervention measure (AIM)

  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.

  Change at 4 months

• Feasibility of intervention measure (FIM)

  The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.

  Change at 8 months

• Feasibility of intervention measure (FIM)

  The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.

  Change at 6 months

• Feasibility of intervention measure (FIM)

  The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.

  Change at 4 months

Secondary Outcomes (9)

• Implementation Survey Response

  Change at 8 months

• Implementation Survey Response

  Change at 6 months

• Implementation Survey Response

  Change at 4 months

• Motivation Survey Response

  Change at 8 months

• Motivation Survey Response

  Change at 6 months

Other Outcomes (27)

• attrition

  Change at 8 months

• attrition

  Change at 6 months

• attrition

  Change at 4 months

Interventions

Financial Incentive and Text-Messages BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all participants, age ≥ 18 years old.
• For intervention trial and patient feasibility and acceptability measurement: Patients with first-episode psychosis, enrolled in Coordinated Specialty Care at the Psychosis Education, Assessment, Care and Empowerment (PEACE) clinic and Psychosis Evaluation and Recovery Center (PERC).
• For clinician feasibility and acceptability measurement at intervention sites: Clinicians working at PEACE and PERC where the intervention will be piloted.
• For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: Clinicians in Connection LHS who work at sites other than PEACE and PERC.Participants must sign the informed consent form

You may not qualify if:

• For intervention trial and patient feasibility and acceptability measurement: Expectation of leaving coordinated specialty care programing within 6 months (which will exclude all of the PI's patient panel) and/or intellectual disability of sufficient degree that the patient's primary psychiatrist expects to compromise capacity to consent to this research and/or psychosis secondary to another medical condition (which may not share the same motivational features that are otherwise understood about the primary psychiatric conditions with psychosis).
• For clinician feasibility and acceptability measurement at intervention sites: Study investigators who work at these clinics will be excluded from participation in the feasibility and acceptability study component given their role in the trial planning and execution.
• For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: none.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Penn Innovation in Suicide Prevention for Implementation Research (INSPIRE) Center: collaborator

Study Sites (3)

University of North Carolina at Chapel Hill (ENCOMPASS Program)

Raleigh, North Carolina, 27608, United States

Location

PEACE Program, Horizon House, Inc.

Philadelphia, Pennsylvania, 19123, United States

Location

University of Pennsylvania

Philadephia, Pennsylvania, 19104, United States

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: August 1, 2023
• Study Start: February 1, 2025
• Primary Completion: December 18, 2025
• Study Completion: March 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (3)