NCT04497857

Academic-Community EPINET (AC-EPINET)

Academic-Community EPINET (AC-EPINET): Mitigating Barriers to Care PILOT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial.

Detailed description

160 subjects will be randomized into a 12 month study, to one of two treatment arms. The investigators will assess four important elements of engagement to determine which are most sensitive to TH treatment and mediates effects on hospitalization rates. The investigators will assess acceptability and satisfaction of CSC-TH compared to CSC-SD, and deliver a training manual for implementing TH in CSC clinics and for use in future research. Although this study has exploratory aims consistent with pilot projects, The investigators have incorporated methodological rigor where possible (randomization, powering for hospitalization rate) in order to achieve the most robust data to assess the main study questions and inform future trials.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorders
• Major Depression With Psychotic Features
• Bipolar Disorder With Psychotic Features

Interventions

Type	Name	Description
OTHER	Coordinated Specialty Care (CSC)	CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders

Timeline

• Start date: 2022-03-16
• Primary completion: 2025-07-29
• Completion: 2025-07-29
• First posted: 2020-08-04
• Last updated: 2025-12-24

Locations

6 sites across 1 country: United States